Corium is having another crack at getting its weekly patch treatment for Alzheimer’s disease to market, securing a March PDUFA date a little more than one year after the FDA rejected its first try.
The FDA hit Corium with a complete response letter last summer, setting back the company’s plans to start selling a patch formulation of donepezil for the treatment of Alzheimer’s. Corium designed the once-weekly patch to spare patients the need to remember to take donepezil, the active ingredient in Aricept, orally and used data on the Eisai-Pfizer drug in its 505(b)(2) filing.
After the FDA rejection, Corium began a crossover pharmacokinetic study to compare two doses of its transdermal patch to Aricept in healthy volunteers. Corium, which wrapped up the trial in April, included data from three studies conducted after the FDA rejection in its latest filing. The FDA is set to decide whether to approve the patch, branded Adlarity, by March.
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Approval of Adlarity would enable patients to access donepezil in a new delivery format. The FDA has previously approved donepezil as a once-daily tablet and as an orally disintegrating tablet. Both of the existing formats create the risk of missed doses as well as gastrointestinal side effects.
Corium is going into its latest attempt to get Adlarity to market on the back of the FDA approval of another of its drugs, ADHD treatment Azstarys. The July approval showed Corium can get products to market. In the past, Corium has been involved in complete response letters for Adlarity and Twirla, a contraceptive patch that it supported as a contract manufacturer. The FDA approved Twirla last year.