Ouch:
>>>>CHAPEL HILL, N.C. & SAN DIEGO--(BUSINESS WIRE)--Oct. 20, 2003--POZEN Inc. (NASDAQ:POZN - News) and Xcel Pharmaceuticals, Inc. (Xcel) announced today that POZEN received a not-approvable letter from the U.S. Food and Drug Administration (FDA) related to its New Drug Application for MT 300(TM). The letter was issued based on the FDA's conclusion that while MT 300 achieved its primary endpoint, it failed to achieve statistical significance versus placebo for the relief at two hours of the secondary symptoms of migraine (nausea, sensitivity to light, and sensitivity to sound). No clinical safety issues were identified in the letter, nor were any non-clinical issues cited as impacting the FDA's decision to issue the not-approvable letter.
In the letter, the FDA acknowledged that MT 300 provided a statistically significant improvement over placebo on the pre-defined primary endpoint of sustained pain relief (defined as relief of migraine pain at two hours that is maintained throughout the next 22 hours) as well as relief of pain at two hours post dose. The sustained relief of the secondary symptoms (defined as relief of secondary symptoms at two hours that is maintained throughout the next 22 hours) was a secondary endpoint in both of the Phase III trials. POZEN submitted data indicating that MT 300 provided statistically significant sustained relief of the secondary symptoms of migraine with the exception of sustained nausea relief, in one of the two Phase III trials.
"We are disappointed with the Agency's conclusion, but we are committed to working with the FDA to seek to resolve the issues raised in the letter as soon as possible," stated John R. Plachetka, Pharm.D., POZEN's chairman, president, and chief executive officer.
POZEN looks forward to meeting with the FDA to discuss the requirements for resolution of identified issues concerning the New Drug Application. The company does not expect the not-approvable letter for MT 300 will change its financial outlook for 2003.
MT 300 is being developed as a new formulation of dihydroergotamine mesylate (DHE) in a pre-filled syringe. DHE has been used for migraine treatment for over 50 years and is regarded as clinically effective by clinicians worldwide. The MT 300 New Drug Application was submitted to the FDA by POZEN in December 2002 and accepted for filing in February 2003.
Separately, POZEN announced that it received a letter of comments from an advisory group to the Medicines and Healthcare Products Regulatory Agency (MHRA), relating to the Marketing Authorization Application (MAA) for MT 100. POZEN submitted the MAA to the MHRA in October 2002 to obtain marketing approval of MT 100 for the acute treatment of migraine. Following standard procedure in the U.K., POZEN intends to submit a response to the comments raised by the advisory group.
POZEN to host webcast today at 10:00 a.m. Eastern Time
POZEN will host a webcast today, October 20, at 10:00 a.m. Eastern Time to discuss the information in this release. The webcast will be live and archived on POZEN's home page at www.pozen.com.<<
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One might have to listen to the CC to determine if the company has the data the FDA wants, or rather that the drug just plain failed to achieve those secondary endpoints. Any thoughts?
Anyone -- like Nigel -- know the implications of a "letter of comments?"
Cheers, Tuck |
