Over the weekend, specialty drugmaker Endo Pharmaceuticals
Frova was initially launched in 2002 to treat acute migraine headaches. Endo in-licensed the compound near the end of 2004 from drug developer Vernalis. So far the compound hasn't been much of a hit for Endo, with Frova sales growing in the single-digit percentage points to $41 million last year.
Frova was tested in two phase 3 label-expanding studies as a treatment for preventing menstrual migraines. The drug was originally up for FDA review on this label-expanding indication in May, but the FDA extended the PDUFA date another three months to Aug. 19. The data that Endo presented over the weekend was one of the phase 3 studies Endo is using to try and get this expanded label.
In this study, all doses of the drug produced highly statistically significant improvements in the number of headache-free perimenstrual periods for women who took Frova versus a placebo. The drug also reduced the incidence of severe headaches by nearly a third for one patient group taking Frova. These results, combined with the other Frova phase 3 study and the well-known drug profiles for the class of compounds that Frova is in, mean the drug stands a high chance of gaining regulatory approval in August to help prevent menstrual migraines.
It's clear that Endo will need new indications for which to market Frova if it wants to generate substantial new sales growth for the drug. One similar compound, Imitrex from GlaxoSmithKline
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