Thirty months after being knocked back by the FDA, IntelGenx has filed its response to the complete response letter to advance its push to bring its oral disintegrating film migraine drug to the U.S. market.
The candidate, Rizaport VersaFilm, is a formulation of rizatriptan, a selective 5-HT1B/1D receptor agonist that is the active ingredient in Merck’s Maxalt. By delivering the triptan in a disintegrating film, IntelGenx thinks it can ensure the rapid release of the molecule and free migraine patients, many of whom suffer nausea, from having to swallow a pill or consume water.
While the product is approved in Europe, IntelGenx’s attempt to bring the migraine treatment to the U.S. market hit turbulence in 2019 and 2020. The FDA’s 2019 pre-approval inspection resulted in a Form 483 that detailed things that needed attention prior to approval, leading to a complete response letter that raised issues related to chemistry, manufacturing and controls. A second rejection followed in 2020.
The FDA’s complete response letter requested more information but didn’t task IntelGenx with running a new bioequivalence study. Thirty months after receiving the letter, IntelGenx has sent its response to the FDA.
“Based on the feedback from our Type A meeting, we conducted additional product testing and believe that this response provides all of the additional chemistry, manufacturing and controls information that the FDA required. We are looking forward to continuing to work with the agency to make Rizaport VersaFilm available to acute migraine patients,” IntelGenx CEO Horst Zerbe said in a statement.
Days after providing the update, IntelGenx revealed its buprenorphine buccal film has received a GDUFA date from the FDA. The agency will make a decision about the generic version of the opioid Belbuca by Apr. 28, 2023.