RISKS OUTWEIGH BENEFITS OF MIGRAINE DRUG, SAY EXPERTS
A panel of FDA experts has dealt another blow to the marketing prospects of MT 100, a migraine drug candidate developed by pharmaceutical firm Pozen.
In a unanimous vote, the FDA's Peripheral and Central Nervous System Drugs Advisory Committee concluded the benefits of the drug do not outweigh its risks, particularly those of tardive dsykinesia (TD), a movement disorder that affects the face. The panel also recommended future studies, according to an FDA spokeswoman.
MT 100 is a novel combination drug composed of naproxen sodium and metoclopramide HCl in a single tablet. The drug had a proposed indication of acute treatment of migraine headache.
In May 2004, the FDA rejected MT 100 based in part on the potential risks of TD linked to the use of metoclopramide. The FDA also cited a MT 100 clinical trial that failed to meet endpoints on measures of pain as well as symptoms of nausea, photophobia and phonophobia.
In its briefing materials for the FDA advisory meeting, Pozen said it believes TD associated with chronic daily use of metoclopramide is a relatively rare adverse event.
The benefits of MT 100 in the treatment of all migraine attacks have been conclusively shown by the data on its use in the treatment of more than 3,000 subjects in clinical trials, the firm said.
The migraine treatment market had revenues of roughly $2.4 billion in 2003, according to a report from Datamonitor, a business information firm. The migraine treatment market has had revenue growth of roughly 12 percent in recent years, but growth is expected to slow as the market becomes increasingly crowded, said Datamonitor.