>>Endo Pharmaceuticals and Vernalis Receive Action Letter From FDA on FROVA(R) Supplemental New Drug Application
Sunday September 30, 5:00 am ET
CHADDS FORD, PA and WINNERSH, UK--(MARKET WIRE)--Sep 30, 2007 -- Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (NasdaqGS:ENDP - News), and Vernalis plc (LSE:VER.L - News) today announced that the U.S. Food and Drug Administration (FDA) has identified deficiencies and asked for additional information pertaining to Endo's supplemental New Drug Application (sNDA) for FROVA® (frovatriptan succinate) 2.5 mg tablets in a "not approvable" letter. The sNDA is for the additional indication of FROVA for the short-term (six days per month) prevention of menstrual migraine. 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.
While the FDA acknowledged that both pivotal efficacy trials that had been submitted as part of this sNDA met their primary endpoints in significantly improving the number of headache-free perimenstrual periods (PMPs), it questioned whether the benefit demonstrated was clinically meaningful. The FDA also noted that even though serious vascular adverse events were not observed in this drug development program, an increased risk (compared to the approved acute use) could not be ruled out.
"We believe that the data submitted to the FDA was sufficiently compelling to warrant approval of FROVA for the short-term prevention of menstrual migraine based on multiple studies that demonstrated the safety and effectiveness of the new treatment regimen," said Peter A. Lankau, Endo President and Chief Executive Officer. "Despite this, the FDA raised a number of issues that will need to be fully analyzed and then discussed with the FDA. Following this discussion with the FDA, Endo and Vernalis will decide upon the appropriate course of action."
Lankau also noted that Endo is reviewing the impact of the FDA's decision on Endo's financial results for 2007 and that Endo anticipates providing further guidance with its third quarter results.
"We are surprised and disappointed by the FDA's response, as they had not engaged the companies in any dialogue during the extended review cycle as to FDA's interpretation of the data in the application," stated Simon Sturge, Chief Executive Officer of Vernalis plc. "It is important to note that this action does not affect the current approved acute use of Frovatriptan and that, in addition to Frovatriptan, Vernalis has another product on the market and a further seven product candidates in clinical development. We have already been evaluating a number of options for our overall operations which we shall now review in the light of the FDA decision. Vernalis will provide more details of the actions to be taken by the Company in due course."
This announcement is being made in compliance with UK law, which requires publicly traded companies to disclose material information without delay.<<
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I gather Glaxo is trying for this indication with naratriptan. No triptan is approved for it, as you probably know. There aren't any BLOOM-like studies for this more chronic use of triptans, so far as I know. Only meta-analysis of smaller ones. So the FDA may want something BLOOM like for approval in this indication. That's a high risk/reward for companies of Endo size to take & Vernalis' to take on. Maybe Glaxo would do it.
Here's an overview of the CV issues from Medscape (free registration required for the whole thing). There are signals, even in acute use, so with the FDA in hyper cautious mode these days, perhaps this outcome is not so surprising. Though if Sturge is being truthful about the lack of communication from the FDA during the review process, that's certainly annoying, and makes the FDA seem more cavalier than perhaps it really is . . .
medscape.com
Cheers, Tuck |
