Press Release: Endo, Vernalis Plc Drug Frova FDA Review Period To Be Extended Additional Three Months
Endo, Vernalis Plc Drug Frova FDA Review Period To Be Extended Additional Three Months Endo Pharmaceuticals Holdings Inc. and Vernalis today announced that the U.S. Food and Drug Administration (FDA) has informed the companies that it will require an additional three months to review Endoâ€™s previously submitted Supplemental New Drug Application (sNDA) for Frova(r) (frovatriptan succinate) 2.5 mg tablets for the expanded indication of short-term prevention of menstrual migraine (MM). The agency now anticipates completing its review of this application on or before August 19, 2007. As previously disclosed, the original PDUFA (Prescription Drug User Fee Act) review date was May 19, 2007. The companies noted that the FDAâ€™s request relates solely to the presentation of the data and not its content and that no additional data have been requested. "We look forward to working with the FDA to expand Frova(r)â€™s indication and bring this important new prophylactic treatment for menstrual migraine to market," said Peter A. Lankau, President and Chief Executive Officer of Endo. He added that the PDUFA date extension would have no impact on Endoâ€™s 2007 financial guidance. Important Information about Frova(r) Frova(r) was approved by the FDA on November 8, 2001 for the acute treatment of migraine attacks with or without aura (subjective symptoms at the onset of a migraine headache) in adults. Frova(r) is generally well tolerated, with a side-effect profile that is typical of the triptan class of drugs. Frova(r) is indicated for the acute treatment of migraine attacks with or without aura in adults where a clear diagnosis of migraine has been established. Frova(r) is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. The safety and effectiveness of Frova(r) have not been established for cluster headache, which is present in an older, predominantly male population. Frova(r) should not be given to patients with cerebrovascular syndromes, peripheral vascular disease, uncontrolled hypertension, ischemic heart disease, or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetalâ€™s variant angina or other significant underlying cardiovascular disease. Frova(r) should not be given to patients within whom unrecognized coronary artery disease is predicted by the presence of risk factors without a prior cardiovascular evaluation. The most common adverse events (greater than, or equal to 4%) include dizziness, fatigue, paresthesia, flushing, and headache. The FDA-approved dosing for Frova(r) is one 2.5 mg tablet up to three times within a 24-hour period. Frova(r) is not currently approved by the FDA for any indications other than for the treatment of acute migraine headaches, and its safety and efficacy in other indications have not been established.