Frova sNDA not approvable

Vernalis (LSE:VER) was off 20.5p (51%) to 20p on Monday after it and partner Endo (ENDP) received a not approvable letter from FDA for an sNDA for Frova frovatriptan tablets for the short-term prevention of menstrual migraine. Although the selective serotonin (5HT1B/1D) receptor agonist met the primary endpoint of significantly improving the number of headache-free perimenstrual periods in Phase III trials, the companies said FDA questioned whether the benefit was "clinically meaningful." The partners also said that the agency 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." Frova is approved for the acute treatment of migraine with or without aura in adults where a clear diagnosis of migraine has been established. ...