WASHINGTON (Reuters) - As the United States battles a growing opioid abuse crisis, the Food and Drug Administration on Thursday asked Endo International Plc to withdraw from the market its long-lasting opioid painkiller, Opana ER, sending Endo’s shares down more than 12 percent.

FILE PHOTO - A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo

The move marks the first time the agency has called for the removal of an opioid painkiller for public health reasons and comes after a panel of advisers concluded in March that the drug’s benefits did not outweigh the risks.

“We are facing an opioid epidemic - a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” Dr. Scott Gottlieb, the FDA’s newly appointed commissioner said in a statement.

Opioids were involved in more than 33,000 deaths in 2015 and opioid overdoses have quadrupled since 1999, according to the Centers for Disease Control and Prevention.

It remains to be seen whether Endo will comply with the FDA’s request. The company said in a statement it is “evaluating the full range of potential options as we determine the appropriate path forward.”

If Endo refuses to withdraw the product, the FDA could offer the company an opportunity for a hearing to make the case for why the product should not be removed. If, after the hearing, the FDA decided to withdraw its approval, Endo could, in theory, sue the agency.

“Despite the FDA’s request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product’s safety or efficacy when taken as prescribed,” the company said.

Opana ER was approved in 2006 and a reformulated version was introduced in 2012.

In March a panel of advisers to the FDA voted 18-8, with one abstention, that the drug’s benefits no longer outweighed the risks. Data showed that while nasal abuse rates fell, the rate of intravenous abuse increased.

The drug has also been associated with a serious outbreak of HIV and hepatitis C, the agency said, as well as a serious blood disorder known as thrombotic microangiopathy.

“If Endo resists taking this off the market immediately, the people who are injured or killed as a result of it being on the market longer than it should, there will be a wave of product liability litigation against the company,” said Sidney Wolfe, founder and senior adviser to consumer watchdog Public Citizen.

Ohio filed a lawsuit in May against the pharmaceutical industry, charging that a number of companies, including Endo, Purdue Pharma, Teva Pharmaceutical Industries Ltd, Johnson & Johnson and Allergan Plc conducted misleading marketing campaigns that downplayed the drugs’ addictiveness. Other states and cities have filed similar lawsuits.

Gottlieb said the agency will “continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”

Randall Stanicky, an analyst at RBC Capital Markets, said Opana ER is a declining asset whose sales are expected to fall to $97 million in 2019, down from an estimated $134 million in 2017.

Endo’s shares fell 12.2 percent to $12.10 in extended trading.</s>FRIDAY, June 9, 2017 (HealthDay News) -- Sales of reformulated Opana ER, a prescription opioid painkiller, should be halted in the United States, the U.S. Food and Drug Administration says.

In its request Thursday for Endo Pharmaceuticals to voluntarily withdraw the drug, the FDA said the benefits of the drug may no longer outweigh the risk of abuse. It's the first time the FDA has moved to take an opioid pain medication off the market due to the public health threat of abuse.

The FDA's analysis of data gathered after the drug was approved showed that injection abuse of reformulated Opana ER (oxymorphone hydrochloride) was linked with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder called thrombotic microangiopathy.

In March 2017, an FDA advisory committee concluded that the benefits of reformulated Opana ER no longer outweigh its risks.

"We are facing an opioid epidemic -- a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse," FDA Commissioner Dr. Scott Gottlieb said in an agency news release.

"We will continue to take regulatory steps when we see situations where an opioid product's risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse," he added.

Addiction to prescription opioids, which include oxycodone (Oxycontin, Percocet) and hydrocodone (Vicoprofen), is a growing epidemic in the United States. The number of opioid overdose deaths has quadrupled in the past 15 years, health officials report.

Opana ER was first approved in 2006 for the management of moderate-to-severe pain in patients who required an around-the-clock opioid for an extended period of time. In 2012, Endo replaced the original formulation of Opana ER with a new formulation intended to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting.

However, the FDA has concluded that the reformulation can't meaningfully reduce abuse of the drug.

"The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in the news release.</s>The following Schedule 2 narcotics are shown : Morphine Sulfate, OxyContin and Opana on January 18, 2013 in Carmichael, Calif. File Rich Pedroncelli / AP File

For the first time ever, the Food and Drug Administration has asked a drug company to pull a painkiller off the market because it has such a high potential for abuse.

The FDA said Thursday that Opana ER, an extended release form of the opioid drug oxymorphone made by the drug company Endo, was being crushed up and injected by people seeking to abuse it.

“Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market,” the FDA said in a statement.

“After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.”

The company is pushing back, saying the drug is safe and effective. The FDA says if Endo doesn’t voluntarily pull the drug from the market, it will withdraw approval.

“Endo is reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward,” Endo said in a statement.

“Despite the FDA's request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product's safety or efficacy when taken as prescribed.”

Opana is one of many opioid drugs being abused in the opioid epidemic that is sweeping the United States.

The Centers for Disease Control and Prevention says opioid overdoses have hit record highs, killing more than 47,000 people in 2014 — more than the 32,000 who died in road accidents.

"We are facing an opioid epidemic - a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse," FDA commissioner Dr. Scott Gottlieb said in a statement.

Endo, which sold $158 million worth of Opana ER in 2015, had reformulated the pills in 2012 and sought to get them labeled as abuse deterrent.

The FDA said that reformulation made things worse.

“The FDA’s decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation,” it said.

“Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C,” it added. Both viruses spread when people share needles.

Cities and states have started suing makers of opioid drugs, saying that they’ve pushed their drugs on doctors and patients alike, helping drice addiction. Studies show most addicts start out using opioids to treat legitimate pain.

Endo is one of five companies being sued by Ohio, the second state to sue companies after Mississippi. Everett, Washington sued Purdue Pharma, the maker of the opioid Oxycontin.

"The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak," said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

"When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” Woodcock added in a statement.

“This action will protect the public from further potential for misuse and abuse of this product.”</s>The U.S. Food and Drug Administration (FDA) requested on Thursday that the drug Opana ER be pulled from the market — the first time the agency has taken steps to remove a currently prescribed opioid pain medication from the market because of its potential for abuse.

The request, at this time, is voluntary. Opana manufacturer Endo Pharmaceuticals said in a statement Thursday that the company "is reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward."

In an FDA statement announcing the request, Dr. Scott Gottlieb, commissioner of food and drugs, cited the country’s ongoing opioid epidemic as a reason for the agency’s actions.

"We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits," he said, "not only for its intended patient population but also in regard to its potential for misuse and abuse."

Opana ER (extended-release) was approved in 2006 for the management of moderate-to-severe pain when around-the-clock relief is needed. Because of the increased risks of addiction and overdose with extended-release opioids, doctors are instructed to prescribe Opana ER only to patients for whom alternative treatment options are ineffective, not tolerated or otherwise inadequate.

In 2012, Opana ER was reformulated with the intention of making the tablets more resistant to manipulation for abuse by snorting or injecting. But the FDA determined that there wasn’t enough data to show the reformulation could meaningfully reduce abuse — and it declined Endo’s request to tout any abuse-deterrent properties on the label.

Now, the FDA says it has concerns that the benefits of the drug no longer outweigh its risks. Following the product’s reformulation , the agency says, data has shown a "significant shift in the route of abuse of Opana ER from nasal to injection."

Injecting the drug has been associated with a serious outbreak of HIV and hepatitis C , as well as cases of a serious blood disorder.

"When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market," said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in the FDA’s statement. "This action will protect the public from further potential for misuse and abuse of this product."

If Endo chooses not to remove Opana ER from the market, the FDA intends to formally withdraw approval. The agency says it will also continue to examine the risks and benefits of all approved opioid pain medicines, "and will take further actions as appropriate as a part of our response to this public health crisis."

In its own statement, Endo acknowledged that the misuse and abuse of opioids have greatly increased in the United States. But it also stresses that the FDA’s request "does not indicate uncertainty with the product’s safety or efficacy when taken as prescribed."

It also notes that, while an FDA advisory committee voted 18 to 8 that Opana ER’s benefits no longer outweigh its risks, more than half of the committee members expressed their preference that the drug remain on the market with new regulatory restrictions.

Although official government data for 2016 has not yet been released, preliminary data compiled by the New York Times shows that U.S. drug overdose deaths last year most likely exceeded 59,000 — the largest annual jump ever recorded.

Overdosing — on opioids as well as illicitly manufactured drugs — is now the leading cause of death among Americans under age 50, the newspaper reported this week.</s>TRENTON, N.J. (CBS News/AP) – U.S. regulators want a narcotic painkiller involved in the opioid epidemic off the market amid data showing people continue to abuse it.

The Food and Drug Administration said Thursday it has asked Endo Pharmaceuticals to stop selling its reformulated, extended-release painkiller, Opana ER, after concluding the drugs’s risks outweigh its benefits.

It’s the first time the FDA has asked a drugmaker to remove an opioid painkiller from the market. The agency said it has seen a “significant shift” from people crushing and snorting Opana ER to get high to injecting it.

Endo said in a statement it’s “reviewing the request and is evaluating the full range of potential options.”

Wall Street responded quickly with a sell-off, and Endo shares plunged 13.4 percent to $11.93 in trading after U.S. markets closed.

The FDA move comes after advisers, reviewing the safety of Opana ER at a March hearing, voted 18-8 against keeping it on the market.

Besides contributing to overdoses, abuse of Opana ER was blamed for a 2015 outbreak of HIV and hepatitis C in southern Indiana linked to sharing needles, according to the FDA.

“We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” FDA Commissioner Dr. Scott Gottlieb said in a statement. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits.”

About 2 million Americans are addicted to prescription opioids, and 91 die every day from overdosing on a painkiller or much-cheaper heroin.

Overdoses are now the leading cause of death of Americans under the age of 50. According to preliminary data compiled by The New York Times, deaths last year likely topped 59,000 — 19 percent more than the year before.

Endo first got U.S. approval for its extended-release opioid, Opana ER, in 2006. It reformulated that drug in 2012 and claimed the changes made it harder to manipulate physically or chemically to abuse it. Endo tried to persuade FDA officials that the new formulation was abuse-resistant, which likely would have given the product a marketing advantage in the crowded, lucrative category of opioid painkillers.

The FDA didn’t agree, refusing to let Endo market the new formulation as abuse-deterrent when it granted approval for sales several years ago.

If Endo doesn’t comply with the FDA’s request to stop selling Opana ER, the agency can hold a hearing and start a formal process for rescinding its approval.

According to the FDA, there are no generic versions of the reformulated Opana ER on the market. However, generic versions of both the original Opana ER and the original immediate-release version, called oxymorphone ER, are on sale.

Those generic products might also face action by the FDA, which said it is “assessing the latest available data on abuse patterns.”

Endo Pharmaceuticals makes generic pills and specialty drugs, which generally are expensive medicines for complex disorders. It’s part of Endo International plc, which is based in Dublin, Ireland, and has U.S. headquarters in the Philadelphia suburb of Malvern.

Endo had about $4 billion in revenue last year, only $159 million of that from Opana.</s>WASHINGTON, June 8 (Reuters) - The U.S. Food and Drug Administration said on Thursday it has asked Endo International Plc to withdraw from the market its long-lasting opioid painkiller Opana ER, sending the company's shares down more than 12 percent.

"After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks," the agency said in a statement.

The move comes after a panel of advisers concluded in March that the benefits of Opana ER, which was approved in 2006 and reformulated in 2012 to resist abuse, did not outweigh the risks. While nasal abuse rates fell, the rate of intravenous abuse increased.

The withdrawal marks the first time the agency taken steps to remove an opioid pain medication due to the public health implications and comes amid an intense national debate about the abuse of opioids. Opioids were involved in more than 33,000 deaths in 2015 and opioid overdoses have quadrupled since 1999, according to the Centers for Disease Control and Prevention.

"We are facing an opioid epidemic - a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse," Dr. Scott Gottlieb, the FDA's newly appointed commissioner said in a statement.

Opana ER has also been associated with a serious outbreak of HIV and hepatitis C, the agency said, as well as a serious blood disorder known as thrombotic microangiopathy.

The move coincides with a lawsuit filed on May 31 against the pharmaceutical industry by Ohio, charging that a number of companies, including Endo, Purdue Pharma, Teva Pharmaceutical Industries Ltd, Johnson & Johnson and Allergan Plc conducted misleading marketing campaigns that downplayed the drugs' addictiveness. Some other states and cities have filed similar lawsuits.

Gottlieb said the agency will "continue to take regulatory steps when we see situations where an opioid product's risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse."</s>The Food and Drug Administration has asked Endo Pharmaceuticals, the manufacturer of Opana ER, an extended-release semi-synthetic opioid painkiller, to remove the drug from the market, after the agency concluded that the drug’s potential for abuse outweighed its therapeutic value.

Endo had reformulated Opana ER (oxymorphone hydrochloride) to make it more difficult to abuse, but the FDA determined that this change ultimately resulted in a “significant shift in the route of abuse of Opana ER from nasal to injection.”

Oxymorphone hydrochloride is known for the potent high that results when it is ground, mixed with water, and injected. It has a short half-life, meaning the desired high is gone sooner than with other opioids. As a result, some who abuse Opana ER are injecting the drug more frequently.

The FDA was able to link the shift from Opana inhalation to injection with a serious outbreak of HIV and hepatitis C, as well as cases of thrombotic microangiopathy, a dangerous blood disorder.

“When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research in a statement. “This action will protect the public from further potential for misuse and abuse of this product.”

Opana was linked to the 2015 HIV outbreak in the rural Indiana community of Austin that resulted in dozens of confirmed HIV cases in a town of only around 4,000 people. The outbreak was so severe that then-Governor Mike Pence declared a public health emergency, creating a temporary exception to the state’s ban on needle exchange programs. Though Pence had openly opposed needle exchanges, he eventually signed a new law that allows for their use in similar emergencies.

When reached for comment by Consumerist about the FDA’s request, Endo would not say whether it will oblige the FDA and remove Opana ER. Instead, the company says it is “evaluating the full range of potential options as we determine the appropriate path forward.”

Endo contends that the FDA’s request for removal “does not indicate “uncertainty with the product’s safety or efficacy when taken as prescribed. Endo remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients.”

The FDA says that if Endo is not willing to voluntarily remove the product from the marketplace, they will take steps to formally require its removal.

“We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” said FDA commissioner Scott Gottlieb.</s>The U.S. Food and Drug Administration (FDA) announced today (June 8) that it has requested that Endo Pharmaceuticals, a drug company, remove the opioid painkiller Opana ER from the drug market.

This is the first time that the federal agency has requested that a drug company voluntarily stop selling a medication because of the risk of abuse that the drug carries, the FDA said in a statement. If the company does not choose to do so voluntary, the FDA will force the issue by withdrawing its approval for the drug.

The request was made after the FDA determined that injecting the drug, which is one way of abusing it, was linked to outbreaks of disease, including HIV and hepatitis C. [America's Opioid-Use Epidemic: 5 Startling Facts]

"The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak," Dr. Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, said in a statement.

In March, an advisory committee of independent experts voted 18 to eight that the benefits of the drug no longer outweighed its risks.

"When we determined that the product had dangerous and unintended consequences, we made a decision to request its withdrawal from the market," Woodcock said. "This action will protect the public from further potential for misuse and abuse of this product."

Opana ER (oxymorphone hydrochloride) was first approved by the FDA in 2006 for use by people with moderate or severe chronic pain. The extended-release formulation of the medication allowed for a continuous release of the drug into the body.

The drug was reformulated in 2012 in an attempt to make the medication more difficult for people to abuse; specifically, the drug makers sought to make it difficult for users to snort or inject the drug. Although the reformulated drug was approved, the FDA later determined that this change did not "meaningfully reduce abuse." The agency said that it would not allow the company to label the drug with language describing its potentially abuse-deterring properties, the statement said.

An FDA review of available data on the drug found that the way people abuse the medication had shifted significantly after its reformulation, changing from snorting to injection. The increase in injection of Opana ER has been linked to outbreaks of HIV and hepatitis C, two viruses that can be transmitted through syringes. There have also been cases of a serious blood disorder called thrombotic microangiogpathy linked to the abuse of the drug.

The FDA has previously requested that companies remove opioid painkillers from the market; however, in those cases it was not because of the risk of abuse that the drug carried. In 2010, for example, the FDA recommended that drug companies stop selling the opioid pain reliever propoxyphene, but this was done because the agency determined that the drug was dangerous for heart health.

In addition, the FDA said it will continue to look at the risks versus the benefits of all other opioid painkillers on the market and take further action if needed.

"We are facing an opioid epidemic — a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse," FDA commissioner Dr. Scott Gottlieb said in the statement. "We will continue to take regulatory steps when we see situations where an opioid product's risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse."</s>FDA Asks Drug Maker To Pull Opioid Opana ER Off The Market

The Food and Drug Administration requested drug maker Endo Pharmaceuticals stop selling Opana ER, which is an opioid. NPR's Robert Siegel speaks with Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, about the decision.</s>June 8 (Reuters) - The U.S. Food and Drug Administration said on Thursday it has asked Endo International to withdraw from the market its long-lasting opioid painkiller Opana ER, sending the company's shares down as much as 13 percent.

"After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks," the agency said in a statement.

It is the first time the agency has taken steps to remove an opioid pain medication due to the public health implications of abuse.
The U.S. Food and Drug Administration asks pharmaceutical manufacturer Endo International plc to withdraw its long-lasting (12 hours) opioid painkiller, Opana ER, from the market after an FDA panel concluded the drug's benefits no longer outweighed the risks of abuse. Endo is evaluating its options.