Supernus Receives FDA Approval for ONAPGO™ (Apomorphine Hydrochloride) to Treat Parkinson’s Disease
Wednesday, February 05, 2025
Supernus Pharmaceuticals, Inc a biopharmaceutical company focused on developing and marketing treatments for central nervous system (CNS) diseases, has received approval from the U.S. Food and Drug Administration (FDA) for ONAPGO (apomorphine hydrochloride) injection. Previously known as SPN-830, it is the first and only subcutaneous apomorphine infusion device approved for managing motor fluctuations in adults with advanced Parkinson’s disease. Supernus plans to introduce ONAPGO in the second quarter of 2025, supported by a dedicated team, including a nurse education programme and patient access assistance.
Continuous subcutaneous apomorphine infusion has been used in Europe for 30 years, helping to provide more consistent control of motor fluctuations in patients. In a European clinical trial, those treated with ONAPGO showed a significant reduction in daily OFF time and an increase in GOOD ON time. The FDA approval offers an option for patients in the U.S. who do not respond well to current treatments, including levodopa. ONAPGO is a lightweight, wearable device that delivers continuous infusion without requiring invasive surgery.
The approval follows results from a Phase 3, 12-week, multicentre, randomised, placebo-controlled study involving 107 patients. The primary endpoint measured the change in total daily OFF time from baseline to the end of the 12-week treatment period, as recorded in patient diaries. Key secondary endpoints included changes in daily GOOD ON time, defined as ON time without troublesome dyskinesia, and the Patient Global Impression of Change (PGIC).
ONAPGO provides a new treatment approach for adults with Parkinson’s disease experiencing motor fluctuations. Supernus has extensive experience in CNS treatments, with a portfolio of over eight widely used products. The introduction of ONAPGO reinforces the company’s commitment to developing new options for managing Parkinson’s disease and other neurological conditions.
As Parkinson’s disease progresses, levodopa treatment may become less effective due to gastrointestinal issues, inconsistent absorption, and the intermittent stimulation of dopamine pathways in the brain. ONAPGO delivers continuous apomorphine infusion, directly stimulating dopamine receptors without requiring metabolic conversion. Its subcutaneous delivery bypasses the gastrointestinal system, allowing for more predictable symptom control.
Patients with Parkinson’s often experience fluctuations between ON states, when medication is effective, and OFF states, when symptoms return. These fluctuations can be disruptive and unpredictable. Continuous treatment options like ONAPGO aim to provide better daily symptom management.
In the Phase 3 study, ONAPGO significantly reduced daily OFF time at 12 weeks compared to baseline. Patients receiving ONAPGO experienced a 2.6-hour reduction in OFF time, compared to 0.9 hours in the placebo group. This improvement was accompanied by a similar increase in daily GOOD ON time, with ONAPGO patients gaining 2.8 hours compared to 1.1 hours in the placebo group. Improvements in OFF time and GOOD ON time were observed as early as the first week and remained consistent throughout the study. Additionally, 79% of ONAPGO-treated patients reported an improvement in their general health, compared to 24% in the placebo group. The most common side effects (occurring in at least 10% of patients) included infusion-site nodules, nausea, drowsiness, infusion-site redness, dyskinesia, headaches, and insomnia.
Parkinson’s disease affects nearly one million people in the U.S. and over 10 million worldwide. It is a progressive and chronic neurodegenerative disorder that causes tremors, muscle rigidity, and difficulties with movement and balance. Many patients also experience dyskinesia, which can interfere with daily activities. The disease impacts both the central nervous system (including the brain and spinal cord) and the peripheral nervous system, which controls bodily functions such as digestion, heart rate, and blood pressure. While there is no cure for Parkinson’s disease, treatments are available to help manage symptoms. Patients using standard therapies may experience GOOD ON periods when medication is effective, or OFF periods when symptoms return. Parkinson’s is the second most common neurodegenerative disorder associated with ageing and the most prevalent movement disorder.
Source: globenewswire.com
