In one of the most significant milestones for depression treatment in decades, the U.S. Food and Drug Administration announced today that it has approved a new drug with esketamine, a derivative of ketamine.

Made by Johnson & Johnson under the brand name Spravato, the drug is meant to be taken as a nasal spray in conjunction with an oral antidepressant and targets patients who have not responded to other treatments. Spravato is the first major new depression treatment to be approved by the FDA since Prozac, which had less side effects than older antidepressants, hit the market more than 30 years ago, and is especially notable because it is supposed to work much more quickly than other drugs.

This is the first time the FDA has approved esketamine for any use (it approved ketamine as an anesthetic in 1970). Despite ketamine’s reputation as a recreational drug, doctors have been prescribing it off-label for years to patients who have not responded to antidepressants and other treatments. The FDA’s advisory committee voted 14-2 (with one abstention) for its approval last month.

The FDA approved esketamine with the caveat that Spravato will only be available through REMS (Risk Evaluation and Mitigation Strategies), its restricted distribution system for drugs with major safety concerns, citing the risk of sedation and dissociation, as well as the potential for abuse and misuse. Patients administer the nasal spray themselves, but they only will be allowed to do so in a doctor’s office or clinic, and cannot take Spravato home with them.

Spravato’s effectiveness was evaluated in three short-term clinical trials, as well as one longer trial. One of the short-term studies, each four weeks long, found that the combination of Spravato and an oral antidepressant demonstrated a “statistically significant effect” compared to a placebo, sometimes within two days (the other two short-term trials did not meet pre-determined statistical tests for effectiveness).

In the longer trial, patients who had stabilized and continued with the medication combo took a “statistically significant longer time” to relapse than patients who received a placebo nasal spray with their oral antidepressant.</s>(CNN) The US Food and Drug Administration approved Janssen Pharmaceuticals Inc.'s esketamine on Tuesday for treatment-resistant depression; the drug is the chemical cousin of ketamine, the powerful anesthetic that has been used illegally as the club drug Special K.

It will be sold as Spravato. More specifically, it's for patients who have tried at least two other medications without success, and it should be taken with an oral antidepressant.

"There has been a longstanding need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products at the FDA's Center for Drug Evaluation and Research, said in a news release announcing the approval.

Spravato is a nasal spray administered by an approved health care provider in a doctor's office or a medical clinic. It may also be self-administered but only under the supervision of a care provider and cannot be taken home.

"Because of [safety] concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient," Farchione said.

Read More</s>The Food and Drug Administration on Tuesday approved a form of ketamine, which is a rapid acting anesthetic that has been used illegally as a party drug known as "Special K," as a treatment for depression. Esketamine, developed by Johnson & Johnson and produced as a nasal spray, can only be administered in a doctor's office.

J&J touted esketamine as the first new drug treatment approved for depression in decades.

The nasal spray is a chemical cousin of ketamine, which has been used for decades as a powerful anesthetic to prepare patients for surgery. In the 1990s, the medication was adopted as a party drug by the underground rave culture due to its ability to produce psychedelic, out-of-body experiences. More recently, some doctors have given ketamine to people with depression without formal FDA approval.

The FDA approved Spravato as a fast-acting treatment for patients who have failed to find relief with at least two antidepressants. Up to 7.4 million American adults suffer from so-called treatment-resistant depression, which heightens the risk of suicide, hospitalization and other serious harm, according to the FDA.

There have been no major pharmaceutical innovations for depression since the launch of Prozac and related antidepressants in the late 1980s. Those drugs target the feel-good brain chemical serotonin, and can take weeks or months to kick in.

Ketamine and J&J's version work differently than those drugs, targeting a chemical called glutamate that is thought to restore brain connections that help relieve depression.

When the drug works, its effect is almost immediate. That speed "is a huge thing because depressed patients are very disabled and suffer enormously," said Dr. John Mann, a psychiatrist and researcher at Columbia University. If the drug doesn't work, physicians can quickly switch to other options, he noted.

The FDA approved Spravato, known chemically as esketamine, based on study results that showed patients taking the drug experienced a bigger improvement in their depression levels than patients taking a sham treatment, when measured with a psychiatric questionnaire.

The drug is designed to be lower-dose and easier to use than ketamine, which is normally given as an intravenous infusion.

Robin Prothro, 60, began taking antidepressants more than 20 years ago. But she says none of the five medications she tried relieved the depression that has stymied her personal and professional life.

Since enrolling in a Spravato trial two years ago, Prothro says her depression has lifted and she's returned to hobbies she abandoned years ago, like gardening.

She takes the drug every two weeks at her psychiatrist's office while reclining in a comfortable chair.

"You can feel it coming on, it's a strong drug," she said, describing colors and shapes that drift before her eyes. "I just let the drug work. I close my eyes and my mind is amazingly quiet."

The ketamine-like drug is the first of several psychoactive substances making their way through the U.S. regulatory process as physicians search further afield for new therapies. Researchers are conducting late-stage trials of psilocybin, the active ingredient in magic mushrooms, and MDMA, a euphoria-inducing club drug, as potential treatments for depression and post-traumatic stress disorder.

"Substantially different agents are only rarely appearing from pharmaceutical companies or other laboratories," said Dr. Paul Summergrad, a psychiatrist at Tufts University. "That's prompting people to investigate other compounds."

Unlike ketamine, psilocybin and MDMA have no legal medical use. Classified in the same category as heroin and LSD, they are tightly restricted by the federal government. But the FDA's approval of esketamine could smooth their path.

Depression is among the leading causes of disability in the U.S. and is being closely monitored by health authorities amid rising suicides nationwide. In 2017, the U.S. suicide rate rose to 14 deaths per 100,000 people, the highest rate in at least 50 years, according to federal records.

Government officials haven't suggested an explanation for the trend, though academic researchers point to the nation's widening income gap, financial struggles and divisive politics.

J&J's drug will be subject to a number of restrictions due to its abuse potential, side effects and lingering safety questions.

The drug will only be given by accredited specialists who must monitor patients for at least two hours after administration, due to its trippy, disorienting effects. Additionally, all patients will be tracked in a registry to monitor long-term safety and effectiveness.

The immediate impact of ketamine is thought to last just four to seven days and there's no consensus yet on how long patients can benefit from ongoing treatment.

Still, there are few other options for patients who fail to respond to antidepressants. The most effective treatment in such cases, electroshock therapy, requires patients to be fully sedated and can cause persistent memory loss.

Wall Street has high expectations for J&J's medication, with analysts predicting more than $600 million in annual sales by 2022. But J&J will face competition in the marketplace.

A decades-old drug, ketamine is already used off-label to treat depression by some doctors. At least 150 clinics around the U.S. provide treatment with various forms of the drug, which is available as a low-cost generic. Patients often pay hundreds or thousands of dollars for intravenous infusions of the drug over several weeks or months. Such therapies are generally not covered by insurance because they haven't been approved as safe and effective by FDA regulators.

Some doctors plan to offer both ketamine and the new J&J drug.

Dr. Steve Levine says having FDA-approved standards for dosing and administering the new drug should raise standards in the field and drive out some of the bad actors who are not qualified to treat depression.

"This is going to bring in some standards, regulation and it's going to make it safer and more accessible to patients," said Levine, who serves as vice president of the American Society of Ketamine Physicians, a group representing doctors, nurses and others using ketamine for treating depression or other nonapproved uses.</s>A drug similar to ketamine has been approved by the Food and Drug Administration (FDA) as a treatment for drug-resistant depression.

The New York Times reports that the drug will be marketed as a nasal spray to those who struggle with treatment-resistant depression. The drug, esketamine, is a chemical cousin to ketamine and will be marketed under the brand name Spravato, developed by the drug company Johnson and Johnson.

Spravato has been approved by the FDA for use among patients who have failed to respond to at least two traditional antidepressant medications, such as Prozac. It will only be available under medical supervision in treatment centers that are approved to administer the drug.

“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in a press release announcing the FDA’s decision. “Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment.”

Although ketamine is FDA approved only as a drug for anesthesia and is best known as the recreational drug Special K, there’s a substantial amount of research to suggest that it could also help alleviate treatment-resistant depression, or depression that does not respond to a standard course of treatment.

According to data from the National Institute of Mental Health (NIMH), nearly 16.2 million American adults have experienced a major depressive episode, or a little more than 6 percent of all Americans. Some estimates suggest that approximately one-third of these adults struggle with treatment-resistant depression (TRD), or depression that does not respond to traditional antidepressant medications.

There are a number of alternative methods that have been suggested to help alleviate treatment-resistant depression, from cognitive behavioral therapy (CBT) to transcranial magnetic stimulation (literally, magnets near your brain). Yet some clinical trials have indicated that ketamine could help alleviate symptoms of depression in as little as 2 hours, which has led some doctors to propose it as a short-term, fast-acting treatment method for those who are admitted to emergency rooms with suicidal ideation. There is also some evidence that ketamine could potentially be used to help treat other mental illnesses, such as posttraumatic stress disorder (PTSD).

In 2017, the use of ketamine in mental healthcare had a breakthrough when the American Psychiatric Association (APA) issued a set of guidelines for how psychiatrists could administer the drug safely and responsibly in a JAMA Psychiatry report. Although the report cautioned against the off-label use of the drug due to the “major gaps that remain in our knowledge about the longer-term efficacy and safety of ketamine infusions,” over the past few years a handful of wellness centers have nonetheless started offering high-priced ketamine injections.

Ketamine doesn’t come with risks: it can cause hallucinations, delirium and changes in perception, as well as nausea and agitation, as can esketamine in high doses. That’s why Spravato will contain a low dose of esketamine and will only be administered under the supervision of a doctor at an approved treatment center.</s>Party drug Ketamine has officially been approved as a treatment for depression by US government officials.

Ketamine, which was originally developed as a horse tranquilizer, will be used as a nasal spray to treat patients who do not respond to traditional depression medications.

On Tuesday, the US Food and Drug Administration (FDA) approved the ketamine-derivative nasal spray, called esketamine, which is being developed by pharmaceutical company Johnson & Johnson.

Ketamine has been used as an anesthetic for decades and was experimentally tested to treat depression in the late 90s.

The drug is believed to work by helping parts of the brain physically damaged by mental illness to ‘blossom’ and heal, so that they resemble those found in a person who does not suffer from depression.

Johnson & Johnson’s subsidiary Janssen Parmaceutical Companies will sell the drug under the brand name Spravato. It will be much purer than ketamine taken illegally by recreational drug users, which would allow doctors to administer smaller doses with less side effects, according to Husseini Manji, the developer of the new drug.

According to Manji, the nasal spray will become effective within hours of use, compared to the four to eight weeks most antidepressants take to start working.

He said patients will get an esketamine dose twice a week for the first four weeks, but if they show signs of improvement the use will be lowered to once every week or two.

‘You can get people better rapidly with the nasal medication but depression is a chronic disease,’ he told ABC News.

Some in the medical community have doubts about ketamine’s use for depression.

Dr Julie Zito, who was one of the two doctors on the FDA’s 16-person board who voted against ketamine’s approval, said she thinks it needs further testing because findings were ‘inconsistent.’

‘The model of using a drug alone and expecting a magic bullet ignores 60 years of experience with antidepressants. We can use a medication as a start, then psychotherapeutic treatment, like cognitive behavioral therapy, that’s evidence-based and shown to be effective, has to come into play and address the problems that are causing the suffering,’ she said.

Manji said medical-grade ketamine has two ‘manageable’ side effects: high blood pressure and disassociation.

‘Colors might seem brighter, sounds might seem brighter, you might not seem real, the room might not seem real,’ he said, but added that the severity of this feeling will dissipate after the first dose.

An FDA approval means that esketamine would likely be covered under many insurance plans, which is not the case for ketamine used as a generic anesthetic, which is not approved for depression.</s>For the first time in years, a new medication will be available for people with depression.

The U.S. Food and Drug Administration approved esketamine, a nasal spray designed to treat severe forms of depression that are unresponsive to at least two other antidepressant medications. The drug will be sold under the brand name Spravato.
• Esketamine: What you need to know about this promising new drug for treatment-resistant depression
• A ketamine-like drug is inching toward FDA approval to treat severe depression

"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," said Dr. Tiffany Farchione, the acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research.

Treatment-resistant depression affects about one-third of the estimated 16.2 million American adults who have suffered a major depressive episode. They have a heightened risk of suicide.

The nasal spray is only available through a restricted distribution system, because of the risk of sedation and dissociation. The drug must be administered in a certified medical setting and the spray cannot be taken home. Depending on the patient, the Spravato should be administered either weekly or every other week.

After administration, patients must be monitored by a health care provider for at least two hours. Patients must also make transportation arrangements because they are not to drive or use heavy machinery for the remainder of the day.

Manufactured by Janssen Pharmaceuticals, Spravato will be priced similarly to other specialty mental health drugs – about $590 to $885 per treatment session, according to CNN. Those prices may vary based on dosage, mandatory discounts and negotiated rebates.

The drug will include a boxed warning noting risks for sedation, difficulty with attention, dissociation, suicidal thoughts, and abuse and misuse.

The most common side effects observed during clinical trials included disassociation, dizziness, nausea, sedation, vertigo, hypoesthesia (reduced sense of touch or sensation), anxiety, lethargy, increased blood pressure, vomiting and feeling inebriated.

The drug has a similar chemical makeup to ketamine, a painkiller with hallucinogenic effects.

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Have a news tip? Let us know.</s>The Food and Drug Administration is expected to announce whether it will approve what could be the first new, novel treatment for depression in decades. It comes in the form of a nasal spray.It's called Esketamine and it's a derivative of ketamine, which is used in hospitals as an anesthetic.Research has shown it can help lift depression, but there are concerns it could also be abused.Ketamine was once known as a party-drug, sparking out-of-body type experiences. Under medical supervision, patients have been paying out-of-pocket for ketamine infusions, which have also been shown to help with depression.If the nasal spray version is approved, it still has to be given at a doctor's office.Many psychiatrists say approving the nasal spray could help millions of people. Sixteen million Americans suffer from depression and at least a third are not helped by traditional anti-depressants."This is a big deal. This is the first time we've had a truly new antidepressant in 50 or 60 years, but we want to make sure we do this in the right way and that people are safe and that they can be helped in the way we hope they are helped," said Dr. Steve Levine.Dr. Levine says the nasal spray would have to be administered by a healthcare provider, patients would then be monitored.The FDA is still weighing in their decision. A few weeks ago, a panel of experts recommended it for approval.</s>The U.S. Food and Drug Administration on Tuesday approved esketamine, an experimental nasal spray that delivers the active ingredients of the “club drug” ketamine, as a new treatment for severe depression.

The Johnson & Johnson nasal spray is a variation of the anesthetic ketamine — a pain reliever that was widely abused as a street drug, Special K, in the 1980s and 1990s. The new drug is especially effective in patients who have not benefited from at least two different therapies, also known as treatment-resistant depression, the FDA said.

"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said in a statement Tuesday.

Intravenous infusions of ketamine have been shown to help people with severe depression who experience suicidal thoughts, but patients are required to see a provider for treatment. Experts believe that the FDA approval of a quick-acting, easy-to-use spray treatmentis a pivotal moment in the history of mental health therapy.

“This offers an extremely important, new treatment for people suffering with treatment-resistant depression,” Dr. Gerard Sanacora, professor of psychiatry at Yale University and director of the Yale Depression Research Program, told NBC News. “We know that if you don’t respond to the first two standard classes of antidepressants, the chances of you responding to a third or fourth reduces significantly, so this drug which has a completely different mechanism of action is particularly effective for those who have no standard treatment.”

“Drug diversion is a real concern for this class of drug, but the plan is that the drug would be given to providers plan who would then administer the drug to patients on-site,” Sanacora said.

Drugmakers believe the spray can help 30 to 40 percent of patients who don't respond to antidepressants.

The spray works more quickly than other known treatments, such as antidepressants which can take two weeks or more to take effect, showing benefits after only four hours.

“This is extremely important for people who need a drug with a quicker clinical benefit. Esketamine may shorten hospital stay or be used in people who have imminent thoughts or risks of hurting themselves,” Sanacora said.

Depression is very common. Around the world, 300 million people are affected and almost 800,000 commit suicide, according to the World Health Organization. In the United States, from 2013 to 2016, eight percent of American adults had depression in a given 2-week period, and about 80 percent of adults reported at least some difficulty with work, home or social activities because of their depression symptoms, according to the Centers for Disease Control and Prevention.

While not every person with depression thinks about suicide, the lifetime risk of attempting suicide for someone with depression is approximately 20 times that of the general population, even among those who receive adequate treatment.

Warning signs aren't always obvious, and they may vary from person to person. Some people make their intentions clear, while others keep suicidal thoughts and feelings secret, underscoring the importance of quick and effective treatment.

“Depression is thought to be the leading cause of disability around the world. At the individual level, there is a close relationship between depression and suicide. In the U.S., there are over 40,000 people a year who die of suicide, and up to 17 percent of people are affected with depression at any given time. So, it’s not only very common but it can have very serious consequences, which is a dangerous combination,” Sanacora said.

The discovery of ketamine’s effects on depression was unexpected and researchers are still unsure how the drug works differently on those with severe depression versus those with milder forms.

In February, a federal advisory panel said the benefits of the nasal spray outweighed the risks. The panel noted that side effects, which include dizziness, nausea, increased blood pressure and an unpleasant feeling of dissociation, should be discussed with patients.

Sanacora, who was the lead author of a consensus statement that supported ketamine's use in the treatment of mood disorders, says the drug is safe for use, but noted its potential for abuse, cautioning that the drug is still not recommended for at-home use.

“We're a long way from this being an at-home or over-the-coutner drug. Drug diversion is a real concern for this class of drug, but the plan is that the drug would be given to providers plan who would then administer the drug to patients on-site,” Sanacora said.

Although today is an exciting next step for the field of novel drug development, he said, experts believe more research on its long-term use and putting measures in place to limit access to teens will play a big role in the drug's success.

“Studies looking at the long-term effects of esketamine have been conducted for up to a year, and there is an extension study that is currently ongoing. For esketamine, there was no evidence of cognitive deficits or trouble with the urinary bladder, as was seen in animal studies and those who frequently misused ketamine,” Sanacora said.

“Most antidepressant drugs are studied up to 8 weeks, so to have this one-year data is pretty unique,” he added.

Previously, the use of ketamine infusions to treat depression was not covered by insurance, and sessions cost in range from $350 to $700. The FDA did not say if the drug would be covered by all or most insurance companies.

Currently, Eli Lilly's Symbyax is the only FDA-approved drug for treatment-resistant depression.

“Esketamine isn’t to be used in place of Prozac. This is meant to be used alongside standard treatments and not instead of standard treatments. We want people to use the medicine responsibly and rationally,” Sanacora said.</s>MJ_Prototype/iStock(NEW YORK) — The U.S. Food and Drug Administration has approved a ketamine-derivative nasal spray to treat depression.

The medication is called eskatamine and it’s developed by Johnson & Johnson subsidiary Janssen Pharmaceutical Companies. Esketamine can now be used for patients who have “treatment-resistant depression,” or patients who didn’t respond to at least two other medications. The FDA made the announcement on Tuesday.

Ketamine, which is commonly known as the street drug “Special-K,” has been used as an anesthetic for decades. It has also been used experimentally to treat depression since the late 90s and has previously been administered with an IV.

Kaiser Permanente offers the IV form of ketamine to treat depression, but representatives for the health care system did not answer repeated requests from ABC News for information about the program, its history and the number of providers and patients who have participated in the program.

Janssen’s new esketamine spray, which will be sold under the brand name Spravato, was developed to be three to four times more potent than regular ketamine, which would allow doctors to administer less and reduce side effects, according to Husseini K. Manji, a developer of the drug and global head of Janssen’s neuroscience therapeutic area.

“We could get away with a very low dose of the drug and fewer side effects,” he told ABC News.

The spray works within hours compared to the four to eight weeks most anti-depressants take to become effective, Manji said.

However, not everyone is enthusiastic about the prospect of a ketamine nasal spray.

“The whole concept is suspect,” Dr. Julie Zito, professor emerita of pharmacology and psychiatry at the University of Maryland, told ABC News.

Zito was one of the two doctors — out on an FDA panel of 16 — who voted against recommending that eskatamine go forward in the approval process, and said that she thinks it needs further review because the findings were “inconsistent.”

“The model of using a drug alone and expecting a magic bullet ignores 60 years of experience with antidepressants,” Zito said, explaining that to think anyone is going to “fix depression” is a mistake. “We can use a medication as a start, then psychotherapeutic treatment, like cognitive behavioral therapy, that’s evidence-based and shown to be effective, has to come into play and address the problems that are causing the suffering.”

With the new drug, patients will get esketamine doses twice a week for the first four weeks, according to Manji. Once they show signs of improvement, treatments can be spread out to once a week or once every two weeks.

“You can get people better rapidly with the nasal medication but depression is a chronic disease,” he added.

Leading up to its approval, researchers examined about 1,700 people over 29 studies, which were executed in various phases with the FDA, according to Manji.

The two major side effects are an increase in blood pressure and disassociation, or feeling disconnected from one’s thoughts, feelings or body. When experienced, both seem to begin about 30 minutes after the treatment and end about 90 minutes afterward.

For about 90 percent of people who experience the blood pressure increase, Manji said it’s akin to “what you or I might have if we exercised.”

He added that with the dissociation, “colors might seem brighter, sounds might seem brighter, you might not seem real, the room might not seem real.” However, the severity of this feeling usually lessened after the first dose.

Because of the potential side effects,”you don’t go home with eskatamine,” Manji said. “You go to a clinic, it’s administered and you stay for 90 minutes and then go home.”</s>The U.S. Food and Drug Administration has approved the first new kind of depression treatment seen in decades, a nasal spray drug based on the sedative ketamine.



The new drug, licensed by Johnson & Johnson’s pharma division, Janssen Pharmaceuticals, isn’t ketamine exactly. It’s derived from esketamine, a chemical sibling of ketamine. It will be sold under the brand name Spravato.

For years, ketamine has been prescribed off-label via IV infusion for people struggling with severe depression and suicidal ideation, with some patients experiencing relief within hours. Importantly, these are typically patients who haven’t responded well to other treatments. The nasal spray will be approved for this same select group of patients.

“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in an FDA statement. “Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment.”

According to the FDA, J&J’s esketamine will be approved for people with treatment-resistant depression, meaning people who haven’t responded to at least two other antidepressant drugs. The drug will need to be taken alongside a standard antidepressant, and each dose will be administered under close medical supervision, with patients being monitored for at least two hours before being allowed to leave the clinic.

Dennis Charney, dean of the Icahn School of Medicine at Mount Sinai, was one of the first scientists to investigate and find evidence of ketamine’s benefits in treating depression and suicidal ideation; he later became one of the co-inventors of the nasal spray. (Charney, Mount Sinai, and others hold patent rights over the drug, which have since been licensed to J&J). Charney told Gizmodo that Spravato will give people who previously couldn’t afford the out-of-pocket costs of ketamine a new option for treatment.

“I’m obviously biased here, but this is honestly a game changer for depression treatment,” Charney told Gizmodo, echoing a familiar refrain shared by many in the field. “I mean, we’re talking about potentially millions of people who might be able to benefit from this treatment, if they haven’t responded to others.”

Because insurance companies typically don’t cover ketamine when used as an antidepressant, patients have been forced to pay hundreds of dollars per infusion out-of-pocket (the number of needed total infusions can vary, depending on the patient and their response, but it’s often half a dozen or more per each treatment course). J&J did not yet respond to a request for comment from Gizmodo concerning the pricing of Spravato.

The FDA’s decision comes in the wake of a nearly unanimous vote by an advisory committee to approve the drug last month. While the majority of experts agreed the benefits of ketamine outweighed any potential risks, short-lasting side-effects such as disorientation, raised blood pressure, and headaches have been commonly found. These same experts, even those who gave the drug their approval, also pointed out the lack of research into its long-term risks as a depression treatment, such as patients developing a substance use disorder or even brain damage—both of which have been seen in recreational users. And they called for long-term research to keep track of new ketamine patients and look out for these risks.

Charney, who said he wasn’t involved in J&J’s clinical development of Spravato, believes it’s important to keep a wary eye on the risks of ketamine. But he noted that ketamine dosages typically given to depression patients are often several-fold smaller than what people take recreationally.

“It’s something we’ve been able to look at for a couple years now. And I and the clinicians I’ve talked to, we haven’t seen that with patients,” he said. “At least so far, the risk of abuse seems to be very low.”
The US Food and Drug Administration approves Janssen Pharmaceutica's esketamine for treatment-resistant depression. The drug is the chemical cousin of ketamine, a powerful anesthetic and recreational drug, and the first major new depression treatment to be approved by the FDA in more than 30 years.