Endo Pharmaceuticals (ENDP) Withdraws Frova Application for Menstrual Migraine
CHADDS FORD, PA--(MARKET WIRE)--Apr 7, 2008 -- Endo Pharmaceuticals Inc., a market leader in pain management and a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (NasdaqGS:ENDP - News), today announced that it has notified the U.S. 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 FROVAÂ® (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, Endo President and Chief Executive Officer. "We appreciate the guidance from the FDA during the development program and its comprehensive review of the supplemental application."
In other matters, Endo announced that it intends to return the rights to CHRONOGESICÂ®, which it had licensed from DURECT Corporation for the U.S. 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(TM)-Sufentanil) licensed by Endo from DURECT for the U.S. and Canada.
Finally, Endo reiterated earlier announcements that it has withdrawn any guidance as to the potential NDA filing dates of its phase III development projects, the ketoprofen patch and RAPINYLÂ®. 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.
Important Information about FROVA
FROVA is indicated for the acute treatment of migraine attacks with or without aura in adults. FROVA 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.
FROVA should only be used when a clear diagnosis of migraine has been established.
As with other drugs in this class, FROVA should not be given to patients with ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, or documented silent ischemia), or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal's variant angina or other significant underlying cardiovascular disease.
FROVA should not be given to patients with cerebrovascular syndromes including (but not limited to) strokes of any type, as well as transient ischemic attacks.
FROVA should not be given to patients with peripheral vascular disease including (but not limited to) ischemic bowel disease.
FROVA should not be given to patients with uncontrolled hypertension.
It is strongly recommended that FROVA not be given to patients in whom unrecognized coronary artery disease (CAD) is predicted by the presence of risk factors unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of coronary artery and ischemic myocardial disease or other significant underlying cardiovascular disease.
It is strongly recommended that patients who are intermittent long-term users of 5-HT1 agonists, including FROVA, and who have or acquire risk factors predictive of CAD, undergo periodic cardiovascular evaluation as they continue to use FROVA.
The development of a potentially life-threatening serotonin syndrome may occur with triptans, including FROVA treatment, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). If concomitant treatment with FROVA and an SSRI (e.g., fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram) or SNRI (e.g., venlafaxine, duloxetine) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
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.
Endo Pharmaceuticals Holdings Inc. is a specialty pharmaceutical company with market leadership in pain management. Through its wholly owned Endo Pharmaceuticals Inc. subsidiary, the company is engaged in the research, development, sale and marketing of branded and generic prescription pharmaceuticals used primarily to treat and manage pain. More information, including this and past press releases of Endo Pharmaceuticals Holdings Inc., is available at www.endo.com.
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