Pozen’s proposed migraine drug known as MT 300 took a major step toward formal approval Thursday when the FDA disclosed that it had accepted Pozen’s new drug application.
While an NDA is not a guarantee of approval, acceptance of it by the FDA said all elements required for final review have been included. Pozen had submitted the NDA in December.
“We believe MT 300 has the potential to become an important new product for patients who need or want a convenient injectable therapy for migraine attacks,” said John Plachetka, Pozen’s chairman and chief executive officer.
The migraine treatment market is estimated at some $3 billion a year. Pozen already has submitted another product, MT 100, for review in the United Kingdom and hopes to file an NDA for MT 100 in the United States by mid-year, according to executive vice president Andrew Finn, who spoke at a recent investors’ conference in Raleigh.
Another drug, MT 400, is currently undergoing Phase II trials.
Finn pointed out that 18 percent of women and 6 percent of men, or 28 million people, suffer from migraines in the United States. He said management is convinced that Pozen has the potential with its three products “have in excess of $1 billion in sales opportunity.”
While there are two other injectable migraine treatments on the market that already generate some $200 million in sales, Finn said MT 300 has additional benefits, including fewer side effects such as nausea and heart pressure.