"Humans have suffered from migraines for millennia. Yet despite decades of research there isnt a drug on the market today that prevents them by targeting the underlying cause. All of that could change in a few months when the Food and Drug Administration is expected to announce its decision about new therapies that have the potential to turn migraine treatment on its head. The new therapies are based on research begun in the s showing that people in the throes of a migraine attack have high levels of a protein called calcitonin generelated peptide or CGRP in their blood. Step by step researchers tracked and studied this neurochemicals effects. They found that injecting https the peptide into the blood of people prone to migraines triggers migrainelike headaches whereas people not prone to migraines experienced at most mild pain. Blocking transmission of CGRP in mice httponlinelibrary.wiley.comdoi.bcp.pdf appeared to prevent migrainelike symptoms. And so a few companies started developing a pill that might do the same in humans. Clinical trials of the first pills were effective against migraine but halted in  over concerns about potential liver damage. So four pharmaceutical companies rejiggered their approach. To bypass the liver all four instead looked to an injectable therapy called monoclonal antibodies  tiny immune molecules most commonly used to treat cancer. Not only do these bypass the liver to block CGRP but one injection appears to be effective for up to three months with almost no noticeable side effects. Two manufacturers Amgen in collaboration with Novartis and Teva Pharmaceuticals have completed clinical trials and expect to hear from the FDA by June whether the therapies have been approved. Two more companies Eli Lilly and Alder Biopharmaceuticals plan to file for FDA approval later this year. Current treatments dont always work Its been a long time coming. Right now the only available preventive treatments are accidental discoveries A number of people prescribed medications for depression high blood pressure and epilepsy discovered migraine relief too. Now many of those drugs including propranolol and topiramate have been tested and approved for migraine. But no one drug works for everyone and side effects can prove intolerable or downright unpleasant. Migraines are throbbing onesided headaches that can be accompanied by nausea as well as sensitivity to light sound smell and movement. At their best the headaches are an annoyance. At their worst they can be completely debilitating. So for those of us who get numerous migraines each month the prospect of a new approach feels almost lifechanging. According to one recent survey https by the Centers for Disease Control and Prevention about  percent of men and  percent of women in the U.S. reported having had a migraine in the last three months. And up to  percent https of all Americans has at least  migraine days every single month. The toll such pain can take on health morale and productivity is substantial. My own migraines started when I was . They struck a few times a week and I thought they were normal headaches httpsamericanmigrainefoundation.orgunderstandingmigraineidentifyingtreatingmigraine. For a while I tried the usual over the counter pain relievers but one by one they stopped working. By age  I started to wonder if there was something seriously wrong with my head. My general practitioner diagnosed me with migraines gave me my first preventive medication  an antidepressant  then sent me to see a specialist. Since that day more than  years ago I have tried six preventive prescription medications. Not one helped. I alternated among four different neurologistrecommended supplements all to no avail. I received bimonthly injections of magnesium and participated in one of the first clinical trials of Botox. And while Botox seemed to decrease my migraines by one or two per month it wasnt enough to bother fighting about it with a new insurance company. I exercised regularly. I experimented with an elimination diet that left me eating nothing but broccoli and white rice but still the migraines came. I averaged about  to  each month. Still I considered myself lucky. The headaches almost never came with nausea and I had medications that typically ousted them within an hour or two. All told I usually lost only a few hours of productivity a week. When I grew older and had two children my body changed and my migraines changed too. I get them less frequently now but when they come they can stick around for a few days or even a week. Abortive medications still work except when they dont. So when I heard about a new approach that was making its way through a number of pharmaceutical company pipelines I began combing through the national clinical trials database http to find a trial near me. I found one about  miles away which didnt seem too far a trek considering the tantalizing reward of a migrainefree life. I made an appointment. Clinical trials seem promising Neurologist David Dodick https at the Mayo Clinic in Phoenix has been involved in multiple clinical trials with each of the four antiCGRP antibody treatments in development. And he admits hes optimistic. He has good reason to be Each of the therapies decreases migraine frequency by at least one to two days per month. In a field where over time the progress and pace of research in understanding the underlying biology and mechanism of disease has been slow this was very exciting he says. Because migraines are not lifethreatening most drugs have to pass a pretty high bar to be approved. And so far patients on the experimental treatments report limited side effects that consist mostly of pain at the injection site https Unlike the current preventive medications there is no nausea no fuzzy thinking no nerve pain no weight loss or gain. And instead of remembering to take a daily pill there is just a oncemonthly injection. Neurologists already have patients eager to test these therapies especially when everything else theyve tried hasnt worked. Theres a big hole to fill both in prevention and acute therapies says Alexander Mauskop httpsnyheadache.comstaffalexandermauskop director of the New York Headache Center in New York City. Disclosure Hes my former neurologist. If I have someone whos really suffering and cant find a solution I tell them that in June I might have something new for them to try. Right now he says he has a list of about two dozen such patients. High price tag Even if the new therapies are approved however patients may still have to jump through a number of hoops to get them. Biologic therapies like these are expensive and treatment could reportedly range https anywhere from  to  a year. At that price Mauskop and other neurologists expect insurance companies to require patients to have tried just about everything else first. The other hitch at this stage is a lack of longterm safety data. If someone is wellcontrolled with Botox or another drug Id not suggest they switch Mauskop says. With Vioxx it took  years before they discovered that it increased the risk of heart problems. Side effects are a potential concern. Elizabeth Loder httpsphysiciandirectory.brighamandwomens.orgDetails chief of headache at Brigham and Womens Hospital in Boston points out that because CGRP constricts blood vessels there may be potential longterm effects on blood pressure or other cardiovascular function. In women of childbearing age who are the ones most prone to frequent migraines you can imagine that might have effects on fertility or placental function. Right now the longest patients have been on one of these new therapies is one to two years. I ask Mauskop whether hed recommend I enroll in a clinical trial given my failure to respond to most everything else. He pauses noting that hes no longer my neurologist and that he cant really give me any suggestions. But then he says that since Id previously shown some response to Botox perhaps I might want to give it another try. I think about my two young children and my risk tolerance. Perhaps in  years Ill feel differently. For now however I pick up the phone and cancel my clinical trial appointment."