Pozen Files NDA Days After Advisory Committee Rejection

August 15, 2005

Pharmaceutical Executive

Pharmaceutical Executive, Pharmaceutical Executive-08-16-2005, Volume 0, Issue 0

Migraine specialist abandons one problematic drug and maintains its position by filing an NDA the following week.

Just four days after an FDA advisory committee put an end to further trials of migraine treatment MT100, manufacturers Pozen Inc. submitted a New Drug Application for another migraine medication, Trexima (Sumatriptan Succinate and Naproxen Sodium).

    The Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously that MT100 did not provide enough benefit, especially since it is only indicated for migraine patients without nausea. The risks of a neurological disorder associated with one of its components, metoclopramide hydrochloride, were said to be too high.

    Metoclopramide, which acts against dopamine receptors, is associated with a disease called tardive dyskinesia, according to a memo to the committee written by Dr. Eric Bastings, the team leader of the Division of Neuropharmacological Drug Products. TD causes repetitive uncontrollable movement, especially in the mouth, such as smacking lips and sticking out of the tongue, Bastings said.

    Peter Young, president of specialist investment banking firm Young & Partners, described the Trexima NDA as a substitute for the failed approval. Pozen promised a quick NDA submission when it announced its decision to halt further research on MT100. The submission was earlier than the end-of-September date many expected, according to Fran Barsky, the company’s director of investor relations.

    The strategy appears to have worked. The two announcements prompted only small movements in the company’s stock prices. They fell 5.1 percent to a price of $7.97 Aug. 4, the day of the announcement. Prices rebounded to $8.29 the next day but dropped 31 cents after the Trexima NDA was filed.

    Like MT100, Trexima contains naproxen. But instead of metoclopramide, it uses sumatriptan succinate, the generic name for GlaxoSmithKlein’s Imitrex. Trexima’s future may be boosted as a result of this partnership with GSK, which is the leader in migraine treatment, Barsky said.

    “We are very happy to be collaborating with them on this,” she stated.

    According to GSK spokeswoman Robin Gaitens, Pozen is responsible for Trexima’s development, clinical trials and regulatory filings. GSK will commercialize all formulations of the drug.

    Analysts may still have some doubts about Trexima’s ability to succeed. In April, after Pozen announced the Phase II trial results for Trexima, Piper Jaffray analyst Deborah Knobelman said she was “cautious” about the drug’s likelihood of approval. But just before the NDA was submitted, Knobelman said that the approval prospects were “marginally higher.”

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