Questions about an infusion device have scuttled Supernus Pharmaceuticals’ attempt to win approval of a Parkinson’s disease therapy. The complete response letter marks the second time in two years that the FDA has knocked back a filing for approval of the continuous treatment of motor fluctuations.
Supernus acquired the apomorphine infusion pump in 2020 and quickly filed for approval of a candidate that it is pitching as potentially the first non-surgical continuous dopaminergic stimulation device. Rather than undergo invasive surgical procedures such as deep brain stimulation, Parkinson’s patients who have symptoms despite taking drugs such as oral levodopa could use Supernus’ drug-device combination.
The company has failed to convince the FDA. In 2020, the agency issued a refuse-to-file notice because the filing for approval of SPN-830 lacked information needed to perform a full review. This time around, the FDA agreed to review the filing but then identified a need for additional information and analyses.
In a statement to disclose the complete response letter, Supernus said the FDA’s request centers on the infusion device and drug product. The agency wants more information on labeling, product quality and manufacturing, device performance, risk analysis and more. Also, the FDA was unable to complete some inspections needed to approve the candidate because of COVID-19 restrictions, according to Supernus.
Supernus remains committed to SPN-830, telling investors that it will continue to work closely with the FDA to address the questions. The company is yet to share a timeline for resubmission, but did reveal the FDA’s initial position is that the next application will be subject to a six-month review. Prior to news of the rejection, Supernus was gearing up to launch SPN-830 in the first quarter of next year.
The company generated earnings of $33.5 million over the first half of the year, causing its bank balance to swell to $508.2 million by the end of June.