The third time is decidedly not the charm for Supernus and its Parkinson’s disease infusion pump.
After two prior attempts to win FDA approval for its apomorphine infusion device for the continuous treatment of motor fluctuations (or “off” episodes) in Parkinson’s patients, the agency has once again rejected the therapy.
This time, the complete response letter (CRL) was specifically tied to product quality and the drug’s master file, according to a company regulatory update. The prospect is coded as SPN-830 in Supernus' pipeline.
Supernus recently submitted product quality data that the FDA has “not yet reviewed,” it said.
As for the master file for the infusion device, the company “plans to discuss” the requested information and the steps to resubmit it with the device manufacturer.
A drug master file is an FDA submission that provides confidental information about “facilities, processes or articles” used in drug manufacturing, processing, packaging and storing, according to the agency’s master file guidelines. The filing is proprietary to the device manufacturer, Supernus explained.
The FDA has already finished a “successful preapproval inspection” of the device manufacturer’s facility in February.
Supernus is not deterred and remains “committed to bringing SPN-830 to the market,” CEO Jack Khattar said in a statement. “We will work with the FDA to address the CRL and to successfully resubmit our SPN-830 NDA.”
The infusion pump is designed to be a more convenient and less invasive way to deliver the company’s apomorphine (Apokyn), which is currently administered via subcutaneous injection.
Supernus’ string of regulatory stumbles started in 2020 when it quickly filed for approval after acquiring the device and Apokyn from US WorldMeds. That first attempt was shut down with an FDA refuse-to-file notice, as the agency said the filing lacked necessary information required to preform a thorough and complete review.
The second rejection came in 2022 in the form of a complete response letter. The agency's correspondence requested additional information on several portions of the application, including labeling, manufacturing and quality, risk analysis and “device performance,” Supernus disclosed at the time.
Further, while the agency didn’t require further efficacy or safety studies, it did need to complete inspections that it couldn’t carry out on time due to COVID-19 travel inspections.
Supernus submitted its most recent approval bid in October, a year after it received the complete response letter. At the time, Supernus believed it had “addressed the FDA’s questions,” the company said in a press release at the time.
The company isn’t the only one to face FDA troubles with a Parkinson’s disease pump. AbbVie last year hit a wall with a rejection for its ABBV-951.
That candidate combined foscarbidopa and foslevodopa, the prodrugs (which become active once inside the body) for the standard-of-care Parkinson’s meds carbidopa and levodopa. The medicine itself wasn’t the concern, but rather the pump device.
European regulators didn’t share the FDA’s hesitancies and authorized AbbVie’s device back in 2022.
Last year, Supernus’ Apokyn contributed $75.1 million to the company’s total 2023 sales haul of $573.9 million.