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news.IntelGenx has announced, together with RedHill Biopharma, that they submitted a response to the complete response letter (CRL) of the US Food and Drug Administration (FDA) for the new drug application (NDA) for their VersaFilm oral film product for the treatment of acute migraines.
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The companies previously reported on 4 February 2014 that they received the FDA’s CRL which raised questions primarily related to third party Chemistry, Manufacturing and Controls (CMC) and to the packaging and labeling of the product.
The FDA’s CRL did not raise any questions or deficiencies relating to the anti-migraine VersaFilm product’s safety and did not require additional clinical studies. IntelGenx and RedHill believe that their response to the FDA addresses all the issues raised in the CRL.
IntelGenx and RedHill will continue working with the FDA on the continuing review of the anti-migraine VersaFilm(TM) NDA, and will provide additional updates as and when applicable.
The product is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck’s Maxalt(R). 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 worldwide annual sales of triptans were estimated to have exceeded $1bn in 20131.
The product is based on IntelGenx’ proprietary VersaFilm technology. It dissolves rapidly in the mouth, leading to the absorption of the drug through the gastro intestinal track and into the bloodstream.
The administration method of the oral thin film does not require the patient to swallow a pill or consume water, and presents a potentially attractive therapeutic alternative for many migraine patients, including those who suffer from migraine-related nausea – approximately 80% of the total migraine patient population.