Pozen Inc, a pharmaceutical development company with a portfolio of product candidates for the treatment of migraine, announced the positive results from a 972- patient, Phase II double blind, placebo-controlled clinical trial with MT 400, its third product candidate being developed for the acute treatment of migraine.

In the clinical trial, MT 400 was significantly better than placebo with respect to the primary endpoint, sustained pain relief, and the secondary endpoints, including relief of pain, nausea, sensitivity to light, and sensitivity to sound, two hours after dosing.

MT 400 was also superior to the oral triptan comparator included in the study as a positive control. At the present time, triptans such as Imitrex, Zomig, and Maxalt are considered "the gold standard" of oral treatments for acute migraine attacks. With respect to the primary endpoint, sustained pain relief, the therapeutic gain with MT 400 was more than twice the therapeutic gain seen with the triptan.

MT 400 also provided superior efficacy versus the triptan with respect to the total number of patients with pain relief at two hours.

"MT 400 has met all our expectations. Although this is only a single double-blind, well-controlled clinical trial, the database is large, robust and compelling," said John R. Plachetka, Pozen's chairman, president and chief executive officer. "However, Phase II results do not necessarily predict the eventual outcomes of Phase III trials and we have substantial work to complete before this product is ready for a New Drug Application to the Federal Drug Administration.

"Based on our clinical trial data, we believe that MT 400, and our other acute treatment product candidates, MT 100 oral tablets and MT 300 injection, will be excellent complementary products for migraine patients. Each has a unique profile, which will allow physicians and patients the opportunity to customize their treatment strategy once these product candidates reach the market," Dr. Plachetka said.

"Pozen is the only company with a portfolio of well-differentiated product candidates that allows this patient-friendly approach. Our marketing research indicates that both physicians and patients really like the profiles of these product candidates and, because of that, we think that they have the potential to generate substantial revenue in the marketplace."