The FDA approved ONAPGOTM (apomorphine hydrochloride) injection, which is also known as SPN-830, on February 4, 2025. It is the first subcutaneous infusion device designed to manage motor fluctuations in adults with advanced Parkinson’s disease (PD). This lightweight, wearable device is expected to launch in the U.S. market by the second quarter of 2025. It is available as a 98 mg/20 mL (4.9 mg/mL) solution of apomorphine hydrochloride.
PD affects more than 10 million people worldwide, of which approximately 1 million people live in the U.S. It is the second most common neurodegenerative disorder associated with aging and the most prevalent movement disorder. This disorder is characterized by various signs and symptoms, such as muscle rigidity, dyskinesia, impaired motor control, and tremors.
Rajesh Pahwa, MD, Professor of neurology at the University of Kansas School of Medicine and director of the Movement Disorder Program at The University of Kansas Health System, as well as a clinical trial investigator for Onapgo, stated that “continuous subcutaneous apomorphine hydrochloride injection has a 30-year track record in Europe, offering thousands of patients with more consistent control over motor fluctuations. He noted that Onapgo provides a new option to the U.S. patients who do not respond well to their current medication including levodopa, without requiring invasive surgery.
The FDA approval of Onapgo is based on findings from the TOLEDO phase 3 clinical trial (NCT02006121), which evaluated the efficacy and safety in PD patients with motor fluctuations that were not well managed by medical treatment. It is a multi-centered (23 European hospitals), parallel, double-blind, randomized, placebo-controlled, and 12-week clinical study. A total of 105 PD patients (male = 66, female = 39; onapgo-treated group = 53, placebo = 52) with a mean age of 63.29 ± 8.80 years were included. The primary efficacy outcome was the reduction in daily OFF time, and the secondary outcome assessed the increase in daily GOOD ON time from baseline to 12 weeks.
The study results showed that Onapgo significantly reduced daily OFF time in the treated group compared to the placebo group (2.6 hours vs. 0.9 hours; p = 0.0114). A significant increase in daily GOOD ON time was observed in treated patients compared to placebo (2.8 hours vs. 1.1 hours; p = 0.0188). It was reported that improvement in GOOD ON time and daily OFF time was noted as early as one week and persisted throughout measured time points.
The most common adverse events, reported in at least 10% of patients, included nausea, vomiting, fatigue, headache, infusion-site erythema, insomnia, somnolence, dyskinesia, orthostatic hypotension, and infusion-site nodules. Additionally, a higher percentage of Onapgo-treated patients reported an improvement in their overall health status compared to placebo group (Patient Global Impression of Change [PGIC]: 79% vs. 24%; p < 0.0001).
In conclusion, the Onapgo subcutaneous device effectively reduces OFF time in PD patients delivering a clinically significant improvement.
Reference:
- gov.in. Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson’s Disease (TOLEDO). 2019:NCT02006121. https://clinicaltrials.gov/study/NCT02006121
- Supernus Pharmaceuticals. Supernus Announces FDA Approval of ONAPGO™ (apomorphine hydrochloride) for Parkinson’s Disease. Published February 4, 2025. Accessed February 5, 2025. https://ir.supernus.com/news-releases/news-release-details/supernus-announces-fda-approval-onapgotm-apomorphine
