NEW YORK, Sept 30 Endo Pharmaceuticals (ENDP.O) and Vernalis (VER.L) said on Sunday the U.S. Food and Drug Administration had identified deficiencies and asked for more information regarding their application for approval of Frova for menstrual migraine prevention.
The companies said they plan to decide on a course of action after analyzing and discussing with the FDA a number of issues that the U.S. agency had raised.
Endo had made a supplemental new drug application for Frova, already approved and marketed for the acute treatment of migraines, for the short-term prevention of menstrual migraines.
While drug trials met their primary endpoints in significantly improving the number of headache-free perimenstrual periods, the FDA questioned whether the benefit was clinically meaningful, the companies said.
The FDA issued a "non-approvable" letter and said that while serious adverse effects were not observed, an increased risk could not be ruled out, they said.
Endo is reviewing the financial impact of the FDA's decision on its 2007 results and plans to provide further guidance with its third-quarter results, the company said.
Vernalis said it has "already been evaluating a number of options" for its overall operations and that it would review those options in light of the FDA decision.
Vernalis said it would provide more details "in due course."