Pozen rocked by delay to migraine drug

Shares in US firm Pozen lost almost half their value on January 26 afterthe US Food and Drug Administration asked for additional studies of its candidate migraine drug MT 100 (metoclopramide hydrochloride plus naproxen sodium). The stock fell 49% to $6.63 on the news, well short of its 52-week high of $21.88, which was achieved in December on optimism surrounding the prospects for the migraine drug.

In a statement, the company said that the agency had requested that it conduct carcinogenicity studies for MT 100, which has completed three Phase III trials, with two additonal pivotal trials near completion. Pozen had originally asked the FDA for leave to skip these carcinogenicity studies, given the long history of safe use of the two compounds included in MT 100. The agency said it wants to establish the safety of the combination and will assist with the design of the required studies.

"We hope to work with the FDA on a package of appropriate studies that will allow us to maintain our timeline for New Drug Application submission," commented John Plachetka, Pozen's chief executive. However, he noted that the program could be delayed by as much as 18 months as a result of the FDA's demands for additional information.