Pozen Inc has reached agreements with the U.S. Food and Drug Administration (FDA) and the Medicines Control Agency (MCA) of the United Kingdom on the development program for MT 400, the company's next generation migraine therapy product candidate.

In the United States, the FDA approved Pozen's request to submit MT 400 as a 505(b)(2) application. In the United Kingdom, the MCA agreed to a similar development program. As part of the agreement, Pozen will not be required to complete chronic toxicology and carcinogenicity studies. The regulatory bodies also indicated that adequate information was available to select a dose, thereby eliminating the need for Phase II dose ranging trials.

"These agreements will significantly reduce our development costs for MT 400 and will allow us to proceed directly to Phase III clinical trials," said John R. Plachetka, chairman, president and chief executive officer.

MT 400 combines a triptan with a long-acting non-steroidal, anti-inflammatory drug (NSAID) in a single tablet. In a previously completed Phase II clinical trial involving 972 patients, MT 400 showed a statistically significant superiority over placebo and its components on two-hour pain response and sustained pain relief, and showed effectiveness in the relief of migraine associated symptoms. Sustained pain relief was defined as patients achieving pain relief within two hours of dosing and neither relapsing nor using rescue medicine over the next 22 hours.

In addition, with respect to sustained pain relief, the therapeutic gain with MT 400 was more than twice the therapeutic gain seen with the triptan. Therapeutic gain was defined as the percent of patients with response on active agent minus the percent of patients with response on placebo control agent.