FDA Declines To Approve Supernus Pharma's Parkinson's Drug

(RTTNews) - The FDA has declined to approve Supernus Pharmaceuticals Inc.'s (SUPN) SPN-830, an apomorphine infusion pump, proposed for the continuous treatment of motor fluctuations, i.e., OFF episodes, in Parkinson's disease.

In the Complete Response letter, issued today, the FDA has asked the company for additional information and analysis related to the infusion device and drug product across several areas, including labeling, product quality and manufacturing, device performance and risk analysis.

However, the regulatory agency has not requested additional efficacy and safety clinical studies.

Supernus noted that it will work towards addressing all questions raised by the FDA, and provide clarity regarding the potential timing of a resubmission of the SPN-830 New Drug Application.

In November 2020, the FDA had refused to review the original New Drug Application for SPN-830, indicating that the filing was not sufficiently complete to permit a substantive review then.

Commenting on today's update, Jack Khattar, President and CEO of Supernus, said, "We are committed to PD patients and to working with the FDA to address the CRL issues so that we can put the NDA back on track towards potential U.S. approval."

SUPN is currently down 4% at $31.95.