FDA gives complete response to Rizaport VersaFilm for migraine

IntelGenx Corp has received a Complete Response Letter from the FDA regarding its resubmitted 505(b)(2) New Drug Application for Rizaport VersaFilm (film formulation of rizatriptan) for the treatment of acute migraines. The issues cited in the CRL relate to the Chemistry, Manufacturing and Controls section of the application. The Agency requested additional information, but no new bioequivalence study.

Comment: Rizaport is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.’s Maxalt. Rizatriptan is considered one of the most effective oral triptans, a class of molecules that constrict blood vessels in the brain to relieve swelling and other migraine symptoms. The administration method of the Rizaport oral thin film does not require the patient to swallow a pill or consume water, and presents a potentially attractive therapeutic alternative as many migraine patients, including those who suffer from migraine-related nausea - approximately 80% of the total migraine patient population.