Shares in US drugmaker Pozen closed up nearly 3% at $9.91 on October 11, reflecting investor enthusiasm on the announcement that the firm and partner GlaxoSmithKline’s New Drug Application for the migraine therapy Trexima (sumatriptan plus naproxen) has been accepted for review by the US Food and Drug Administration.
The FDA’s acceptance of the NDA has triggered a $20 million milestone payment from GSK to Pozen, as per the terms of the companies’ agreement signed in June 2003.
Trexima combines GSK’s Imitrex (sumatriptan), which uses Pozen's RT Technology allowing drugs to quickly dissolve in the stomach, with the nonsteroidal anti-inflammatory, naproxen sodium. Pending FDA approval, the product could be available to patients as early as the latter half of 2006, the companies said.
Commenting on the drug, Stan Hull, senior vice president of US Pharmaceuticals RTPat GSK, said: “This multi-mechanism migraine product may offer an important treatment option for migraine sufferers.” GSK will certainly be hoping Trexima helps its position in the valuable migraine market; approximately 28 million people in the USA alone are afflicted by the condition.