FDA Approves Supernus Pharmaceuticals’ Onapgo for Managing Motor Fluctuations in Parkinson Disease

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The FDA has approved Supernus Pharmaceuticals’ Onapgo (apomorphine hydrochloride) injection, the first and only subcutaneous apomorphine infusion device for managing motor fluctuations in adults with advanced Parkinson disease (PD). According to the company, Onapgo will offer continuous drug delivery via a small wearable device, providing an alternative to invasive surgical options. Approval is based on results from a Phase III trial, which demonstrated significant reductions in daily off time and increased good time.¹

“Continuous subcutaneous apomorphine infusion already has a proven and established 30-year history in Europe, where it has helped deliver more consistent control of motor fluctuations for thousands of patients,” clinical trial investigator Rajesh Pahwa, MD, Laverne and Joyce Rider Professor of Neurology at the University of Kansas School of Medicine, director of the Movement Disorder Program at The University of Kansas Health System, said in a press release. “In a clinical trial in Europe, patients treated with Onapgo experienced a significant reduction in daily off time and a similar significant increase in good on time. Today’s approval of Onapgo means patients in the US who are not responding well to their current treatment regimen, including levodopa, will now have the option of using a small and lightweight wearable device to deliver a continuous infusion without the need for an invasive surgical procedure.”

The primary endpoint of the trial was the mean change in total daily off time assessed from baseline to the end of the 12-week treatment period based on patient diaries, while key secondary endpoints included the mean change in daily good on time based on time without troublesome dyskinesia, and Patient Global Impression of Change.

Results found that 53 patients treated with Onapgo demonstrated a 2.6-hour reduction in daily off time compared to placebo. Additionally, these patients experienced a 2.8-hour increase in good on time, with some reporting results as early as the first week of treatment. Common adverse events (AEs) included infusion-site nodule, nausea, somnolence, infusion-site erythema, dyskinesia, headache, and insomnia.¹

“Onapgo represents a novel approach for adults with Parkinson’s disease who are experiencing motor fluctuations,” said Jack Khattar, president, CEO, Supernus Pharmaceuticals, in the press release. “Supernus’ significant experience in CNS has fueled the success of more than eight widely recognized products in CNS and other therapeutic categories. The addition of Onapgo demonstrates our continued commitment to developing novel alternatives to manage Parkinson’s disease and other neurological conditions.”

According to the Parkinson’s Foundation, an estimated one million people in the United States are currently living with PD. By 2030, this is expected to rise to 1.2 million people. Close to 90,000 Americans are diagnosed with PD annually, with 10 million currently living with it globally.²

"As Parkinson’s disease progresses, levodopa treatment often becomes less effective at delivering consistent motor control in part due to GI dysmotility, variable absorption of oral medication, and the resulting pulsatile stimulation of dopamine pathways in the brain," said Stuart Isaacson, MD, director of Parkinson’s Disease and Movement Disorders Center of Boca Raton, Florida, and a clinical trial investigator for Onapgo, in the press release. "With Onapgo, the continuous infusion of apomorphine directly stimulates postsynaptic dopamine receptors with no metabolic conversion needed. In addition, the subcutaneous delivery of apomorphine bypasses the GI tract and enters the brain, which can allow for more predictable symptom improvement."

References

1. Supernus Announces FDA Approval of ONAPGO™ (apomorphine hydrochloride) for Parkinson’s Disease. Supernus. February 4, 2025. Accessed February 7, 2025. https://ir.supernus.com/news-releases/news-release-details/supernus-announces-fda-approval-onapgotm-apomorphine

2. Who has Parkinson's? Parkinson’s Foundation. Accessed February 7, 2025. https://www.parkinson.org/understanding-parkinsons/statistics#:~:text=Nearly%2090%2C000%20people%20in%20the,are%20diagnosed%20before%20age%2050.