Carbidopa/Levodopa

Onapgo is approved for adult Parkinson’s patients experiencing motor fluctuations. Credit: Inside Creative House via Getty Images. Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of Parkinson’s disease. Supernus’ regulatory path for Onapgo has been marked by multiple setbacks over nearly five years, with the Food and Drug Administration (FDA) rejecting three prior applications before securing approval. The company acquired Onapgo, previously known as SPN-830, from US WorldMeds in 2020. Soon after, Supernus submitted its first application for FDA review. However, in 2020, the agency issued a refusal-to-file (RTF) letter, determining that the submission was incomplete and not ready for formal review. Supernus resubmitted the application twice, receiving complete response letters (CRLs) both times. The first 2022 rejection required further analysis of the infusion device and drug product, while the most recent CRL, issued in April 2023, cited product quality concerns and deficiencies in the master file for the proprietary pump. The company resubmitted its fourth application in August, leading to the current approval. Onapgo will now be available for adult Parkinson’s disease patients experiencing motor fluctuations. The wearable pump is designed to provide a continuous subcutaneous infusion of Supernus’ apomorphine (Apokyn). The drug is intended for patients experiencing “off” periods, where medication wears off and symptoms return or worsen. The approval is based on a Phase III, 12-week study (NCT02006121) involving 107 patients. Onapgo led to a drop in daily “off” time and an increase in daily good “on” time, defined as periods without dyskinesia and the patient’s global impression of change (PGIC). Supernus plans to launch Onapgo in the second quarter of 2025, supported by a team of specialists, a nurse education programme, and access support services. The approval adds Onapgo to a growing list of infusion-based Parkinson’s treatments. AbbVie ’s Vyalev (foscarbidopa and foslevodopa), a continuous subcutaneous infusion therapy combining prodrugs of carbidopa and levodopa, was approved in October 2024 after three regulatory attempts. The FDA’s initial rejection of Vyalev did not involve efficacy or safety concerns but requested additional information on the pump device. The second rejection followed findings of issues at a third-party manufacturer. AbbVie set a precedent in 2015 with its Parkinson’s disease infusion pump therapy Produodopa (foslevodopa foscarbidopa), sparking innovation in drug delivery systems as companies looked for alternatives for conventional oral treatments.

At long last, the FDA approved Supernus Pharmaceuticals’ Parkinson’s disease treatment, which will be marketed as Onapgo. Onapgo is now approved to treat motor fluctuations in adults with advanced Parkinson’s disease. Previously known as SPN-830, the therapy is administered using a pump that continuously delivers apomorphine, a drug used to treat what’s known as “off” episodes in Parkinson’s disease. That’s when Parkinson’s symptoms, like stiffness or tremors, affect patients between doses of medication such as levodopa. In a Phase 3 study, Onapgo reduced the amount of daily “off” time by 2.6 hours compared to 0.9 hours with placebo at 12 weeks. Supernus said Onapgo will be available in the US in the second quarter of this year. Supernus declined to disclose the price for Onapgo, saying it isn’t commenting on pricing before the product is commercially available. Its stock $SUPN was up about 5% on Tuesday morning. The regulator’s approval occurred less than a year after it rejected the treatment for the second time in April. At that time, the FDA said it needed additional information or review time for two items: product quality, and the “master file” for the device part. In 2022, the agency also rejected the drug-device, and in 2020, the FDA refused to review Supernus’ application for SPN-830. Other companies have or are developing similar therapies. AbbVie in October received FDA approval for Vyalev, which is a continuous infusion used to treat Parkinson’s. And Mitsubishi Tanabe Pharma is working to resubmit an application to the FDA for its continuous infusion pump ND0612 after it was rejected. Supernus acquired the program in 2020 as part of its $300 million purchase of US WorldMeds’ CNS portfolio. Supernus is also the maker of the ADHD drug Qelbree, among other drugs for psychiatric and neurologic conditions. Editor’s note: This story was updated with Supernus’ comment on pricing.