FDA requests further analysis of Supernus Parkinson’s treatment

Supernus Pharmaceuticals Inc. announced that the FDA has issued a complete response letter for its new drug application of SPN-830, requesting more information.

SPN-830 is an investigational apomorphine infusion device for treatment of motor fluctuations in Parkinson’s disease.

According to a press release from Supernus, the complete response letter (CRL) requires additional information and analysis related to the infusion device and drug product across several areas of the NDA, including labeling, product quality and manufacturing, device performance and risk analysis.

Further, approval of the NDA requires inspections that could not be completed in a timely manner due to COVID-19 travel restrictions, but additional efficacy and safety clinical studies were not requested, the release said.

Supernus will continue to work closely with the FDA to address all questions and provide clarity regarding the potential timing of resubmission of the NDA, the company said.

“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,” Supernus President and CEO Jack Khattar said in the release. “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.”

The FDA determined that the amendment to Supernus’ application in response to the CRL will be subject to a class 2, or 6-month, review timeline, the release stated.