Supernus Pharmaceuticals’ Parkinson's Drug-Device Combination Fails FDA Approval for a Second Time

Supernus Pharmaceuticals announced on Monday, April 8, 2024, that the U.S. FDA has yet again declined to approve its drug-device combination therapy for the treatment of mobility symptoms associated with Parkinson’s disease. The announcement sent its stocks tumbling by 9% in early trade.

The FDA issued a Complete Response letter (CRL) to Supernus Pharmaceutical’s New Drug Application (NDA) for SPN-830. The CRL means that the application's review cycle was completed but is not ready for approval in its current form.

This is the second time Supernus’ combination therapy has failed to pass the scrutiny of U.S. regulators. The decline is a huge blow to the company’s year-long efforts to bring its pump-based treatment to the market. The regulators mentioned two areas that required additional review before the therapy would be ready for approval, according to the company. 

Back in 2022, the regulators declined the approval of the product citing the need for detailed information relating to product quality and manufacturing, labeling, risk analysis, and device performance. However, the regulators did not ask for additional efficacy and safety studies.

The FDA has asked Supernus Pharmaceuticals to provide additional information

In the current failed attempt to get the product to the market, the regulators are asking for additional information regarding product quality. Supernus Pharmaceuticals recently submitted additional data on the quality of their product. However, the data has yet to be reviewed by the FDA. 

The second area where the FDA is asking for additional information is related to the master file for the infusion device which is proprietary to the device manufacturer. Supernus Pharmaceuticals said it would “discuss with the device manufacturer” and brief them on the requested information as well as “the steps required for resubmission of the NDA for SPN-830”.

In February 2024, the FDA completed a preapproval inspection of the facility of the device manufacturer. Just like the last time, the regulators did not ask for clinical safety or raise efficacy concerns and did not list it as a prerequisite for the 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,” said Jack Khattar, the President and CEO of Supernus Pharmaceuticals. “We will work with the FDA to address the CRL and to successfully resubmit our SPN-830 NDA.”

Supernus is focused on treating central nervous system diseases

Supernus Pharmaceuticals channels its energy and resources into the development and commercialization of products for the treatment of central nervous system (CNS) diseases. Their portfolio includes approved treatments for the treatment of ADHD, epilepsy, chronic sialorrhea, cervical dystonia, and so much more.

According to government estimates, around 1 million people have Parkinson’s disease in the United States. Supernus’s SPN-830 aims to treat the so-called “off episode” which affects almost all Parkinson’s disease patients. It heightens symptoms like tremors and difficulty in walking when the medication wears off. 

Last year, the FDA also declined to approve a similar pump-based treatment by Abbvie which was aimed at treating “off episodes”. Abbvie’s attempt uses a combination of levodopa and carbidopa, which are the standard drugs for the treatment of Parkinson’s.