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
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