Pozen Inc. completed a second Phase III trial demonstrating that MT 100, its lead product candidate for migraine, is as efficacious as Imitrex, the leading marketed product for the condition.
The study showed that a single tablet dose of MT 100 provided comparable efficacy to GlaxoSmithKline plc’s Imitrex 50 mg and was superior to placebo for both two-hour pain relief and sustained pain relief. MT 100 is a proprietary formulation of two approved drugs, a fast-release metoclopramide and naproxen sodium.
“We did a comparative study with Imitrex earlier,” Pozen CEO John Plachetka said. “This was a confirming study that we conducted to a higher standard.”
The Phase III trial, actually the sixth Phase III trial for MT 100, included 1,027 migraine patients in a double-blind, placebo-controlled study conducted at 41 sites in the United States.
“We did [the trial] because we wanted to improve our position in the marketplace, which clearly this does,” Plachetka said, explaining that if companies don’t do comparative trials they are not in a position to give guidance to physicians upon marketing.
With the second trial against the lead comparator, it showed how well MT 100 “works against the gold standard,” he said.
“Because we now have two studies, we should meet the FDA’s criteria for promotional support,” Plachetka said.
The key differentiator between MT 100 and Imitrex, he said, is that there is a different mechanism of action for MT 100 that is devoid of any cardiovascular risk.
Pozen, of Chapel Hill, N.C., plans to submit a new drug application for MT 100 in the first half of 2003.
In January 2001, the FDA informed Pozen that the agency would require the company to conduct carcinogenicity studies of MT 100 in order to submit a new drug application. At the time, analysts said that could set the company back 18 months, and it caused Pozen’s stock to drop 49 percent that day. (See BioWorld Today, Jan. 29, 2001.)
In February this year, Pozen said it had reached agreement with the FDA that the agency would accept results from the company’s ongoing rat carcinogenicity study, scheduled for completion of the in-life portion in August 2003, while the NDA review is taking place.
Pozen has a portfolio of products for migraine. It began the final Phase III trial of MT 300, an injectable dihydroergotamine mesylate compound, in February. The primary endpoint is sustained pain response, with nausea and sensitivity to light as secondary endpoints. The company plans to file an NDA for MT 300 by the end of the year, Plachetka said.
Another product candidate is MT 400, a combination triptan and nonsteroidal anti-inflammatory. Pozen plans to initiate a large, multicenter trial of MT 400 in the near term.
Pozen’s stock (NASDAQ:POZN) fell 6.9 cents Thursday to close at $5.88.