Supernus Pharmaceuticals Inc. has announced that the U.S. Food and Drug Administration (FDA) has disapproved its application for the SPN-830 infusion device.
SPN-830 is an exploratory apomorphine infusion device being evaluated for the long-term treatment of motor disorders in Parkinson’s disease (PD). Before the news of the rejection was announced, the company was planning to launch the infusion device in the first quarter of 2023.
The FDA provided the pharmaceutical firm with a Complete Response Letter (CRL) for its application. According to the CRL, the FDA needs more thorough information and analysis vis-a-vis the infusion device across several aspects of the New Drug Application (NDA). These areas include, but are not limited to, risk analysis, device performance, product labeling and overall quality.
The CRL marks the second time in as many years that the FDA has rejected a request for the approval of the treatment of motor fluctuations. Supernus bought the SPN-830 infusion device in 2020, after which it immediately filed for its approval as potentially the first non-surgical device to fight motor fluctuations in patients with Parkinson’s Disease. This meant that, pending approval, SPN-830 could be used by PD patients as an alternative to invasive surgical operations such as deep brain stimulation.
The FDA further stated that in order to approve the NDA, the agency would need to carry out additional inspections, which could not be finished in a timely manner due to the travel restrictions brought on by the pandemic. These restrictions have also stalled reviews for other drugs. However, the CRL mentioned that no further safety clinical studies are needed.
Supernus will continue to collaborate closely with the FDA to respond to all inquiries and, whenever needed, to shed light on the potential timing of resubmitting the NDA. The FDA has initially decided that the CRL-related update to the firm’s application will go through a Class 2 review timeline.
Jack Khattar, the CEO of Supenus, stated, “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. 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.”
Annabel Samimy, an analyst for Stifel, noted that although Supernus is bitterly disappointed at FDA’s rejection, the company doesn’t consider it a major roadblock in terms of gaining long-term revenue. The FDA’s decision to not ask for more clinical studies is a definite silver lining.
Apomorphine, the main component in Supernus’ infusion device, was actually given the green light by the FDA back in 2004. It was authorized for use as an injection marketed under the trade name “Apokyn”.
Since then, a number of pharmaceutical companies have been working to restructure the existing Parkinson’s drugs in an effort to either improve their effectiveness or ease of use. For instance, ABBVie is currently in discussions with the FDA about giving the go-ahead to a medication that combines synthetic forms of carbidopa and levodopa.
