FDA Issues CRL for Parkinson’s Therapy

The FDA has issued a complete response letter (CRL) for the Supernus Pharmaceuticals’ new drug application for SPN-830. SPN-830 is an apomorphine infusion device under review to treat short-term, intermittent “off” episodes in people with Parkinson’s disease. The infusion device would create a continuous treatment with apomorphine.

The FDA is asking for additional analysis related to the infusion device used with SPN-830. The agency is also requiring inspections of manufacturing facilities.

“SPN-830 remains a key priority for Supernus as there is a need to provide a minimally invasive therapy for PD patients who are experiencing motor fluctuations not adequately controlled with current treatment options,” Jack Khattar, president and CEO of Supernus, said in a press release. “We are committed to Parkinson’s disease patients and to working with the FDA to address the CRL issues so that we can put the NDA back on track toward potential U.S. approval.”

The company had resubmitted the NDA in December 2021 following the agency’s initial refusal to file the application because it was incomplete.

Related: FDA Updates Warning Labels on Parkinson’s Therapies

Supernus markets Apokyn, an injection form of apomorphine but in February 2022, a first generic was approved. The generic was only for Sage Chemical’s drug cartridge, which is compatible for use with the Apokyn pen. It has already been removed from several formularies, including Cigna and Prime Therapeutics, and sales of the therapy have started to slip. In the first half of this year, sales of Apokyn are down 20%.