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Endo Withdraws Migraine Drug Application, Returns Chronogesic Rights to Durect

Posted on: Tuesday, 8 April 2008, 09:04 CDT

Endo Pharmaceuticals, a wholly owned subsidiary of Endo Pharmaceuticals Holdings, has notified the FDA of the withdrawal of the supplemental new drug application for Frova 2.5mg tablets.

This supplemental new drug application (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.

Endo also announced that it intends to return the rights to Chronogesic, which it had licensed from Durect for the US and Canada. 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.

Chronogesic is a sufentanil-containing implantable device intended for the treatment of moderate-to-severe chronic pain.

Source: Datamonitor

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