For the second time in as many years, the FDA has hit Supernus Pharmaceuticals with a Complete Response Letter, citing undisclosed quality and master filing issues for the drug-device combination.
The FDA has for the second time rejected Maryland-based Supernus Pharmaceuticals’ drug-device combination treatment for Parkinson’s disease—this time over quality and device issues—the company announced Monday.
The FDA issued a Complete Response Letter (CRL) to the New Drug Application (NDA) for Supernus’ candidate SPN-830, an investigational apomorphine infusion device designed to provide continuous treatment for motor fluctuations in Parkinson’s disease (PD). The letter said two areas needed more review by the FDA or information from Supernus, including more info about the product’s quality.
“The CRL indicates that the review cycle for the application is complete, but that the application is not ready for approval in its present form,” according to Supernus.
No additional details about the quality of the product or what information the FDA needed were disclosed. Supernus noted that it had recently submitted more product quality data to the regulator, which has not been reviewed yet.
The other issue cited by the FDA is related to the master file for the infusion device. Supernus said that the master file is proprietary and is planning to discuss the regulator’s requested information and steps required to resubmit the NDA with the device manufacturer. At the same time, Supernus said that no clinical safety or efficacy issues were identified as a requirement for approval.
“We remain committed to bringing SPN-830 to the market as an important treatment option for PD patients who experience motor fluctuations associated with off episodes. We will work with the FDA to address the CRL and to successfully resubmit our SPN-830 NDA,” Supernus CEO Jack Khattar said in a statement.
Supernus’ stock dropped approximately 11% in premarket trading Monday morning, according to Seeking Alpha.
This is not the first time the FDA has rejected Supernus’ drug-device treatment. In 2022, the regulator also hit the company with a Complete Response Letter stating that more information and analysis were needed for SPN-830. This included additional details about the candidate’s labeling, product quality, risk analysis and device performance.
The FDA accepted the resubmission of SPN-830’s NDA in November 2023 and successfully completed a preapproval inspection of the device manufacturer’s facility in February 2024.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
