Endo Pharmaceuticals Inc, a market leader in pain management and a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc, has notified the US Food and Drug Administration (FDA) of the withdrawal of the supplemental new drug application (sNDA) without prejudice to refiling as afforded under 21 CFR 314.65 for Frova (frovatriptan succinate) 2.5 mg tablets.
This sNDA was for the additional indication of Frova for the short-term (six days per month) prevention of menstrual migraine. Endo is continuing to evaluate development opportunities for Frova for this indication and other, related indications. Frova is already approved and marketed for the acute treatment of migraine with or without aura in adults where a clear diagnosis of migraine has been established.
"The decision to withdraw the unapproved supplemental application was complex; however, after a lengthy and detailed evaluation of the points raised in the FDA 'not approvable' letter, we have determined the withdrawal to be the appropriate course of action at this time," said Dave Holveck, president and chief executive officer, Endo. "We appreciate the guidance from the FDA during the development programme and its comprehensive review of the supplemental application."
In other matters, Endo announced that it intends to return the rights to Chronogesic, which it had licensed from Durect Corporation for the US and Canada. Chronogesic is a sufentanil-containing implantable device intended for the treatment of moderate-to-severe chronic pain. Under the current terms of this license agreement, Endo is not responsible for any development costs for Chronogesic prior to May 1, 2008 so long as written notification of termination of the agreement is provided to Durect by April 30, 2008. This return of Chronogesic rights has no effect on Durect and Endo's collaboration with respect to the sufentanil transdermal patch (Transdur-Sufentanil) licensed by Endo from Durect for the US and Canada.
Endo reiterated earlier announcements that it has withdrawn any guidance as to the potential NDA filing dates of its phase III development projects, the ketoprofen patch and Rapinyl. The company will not provide guidance on these or its other pipeline projects until the previously announced in-depth review of its R&D pipeline is complete.
Frova is indicated for the acute treatment of migraine attacks with or without aura in adults. It is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. The safety and effectiveness of Frova have not been established for cluster headache, which is present in an older, predominantly male population.
The most common side effects associated with the use of Frova are dizziness, fatigue, paresthesia, flushing, headache, dry mouth, hot or cold sensation, skeletal pain, chest pain, and dyspepsia.
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