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FDA approves ONAPGO (SPN-830) as the first subcutaneous apomorphine infusion device for advanced Parkinson’s disease

On February 4, 2025, the U.S. Food and Drug Administration (FDA) approved ONAPGO (apomorphine hydrochloride infusion), formerly known as SPN-830, marking a transformative milestone in the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD).1

PD is a chronic and progressive neurodegenerative disorder affecting nearly one million people in the United States and over 10 million worldwide.2 Characterized by motor symptoms such as tremors, rigidity, bradykinesia, and postural instability, PD significantly impairs quality of life. Despite advances in treatment, many patients with advanced PD experience “OFF episodes” – periods when their medications lose effectiveness, causing motor symptoms to return,3 which represent a critical unmet need in PD management.

The Mechanism of ONAPGO

ONAPGO is the first and only subcutaneous apomorphine infusion device designed to provide continuous, wearable treatment during waking hours. This innovative therapy offers consistent control of OFF time, empowering patients to achieve more predictable symptom relief and improved daily functioning.1

Apomorphine, a potent dopamine agonist, has long been recognized for its ability to manage OFF episodes in patients with PD. It directly stimulates postsynaptic dopamine receptors in the brain, bypassing the gastrointestinal (GI) tract and providing rapid and reliable symptom relief.3 However, traditional subcutaneous injections of apomorphine require frequent dosing, which can be inconvenient and burdensome for patients.

ONAPGO addresses these challenges through its cutting-edge delivery system—a small, lightweight, wearable pump that administers a steady infusion of apomorphine over 24 hours. This ensures consistent therapeutic levels of the drug, minimizing fluctuations and offering a seamless solution for patients. By delivering medication continuously, ONAPGO reduces the frequency and severity of OFF episodes, improving both mobility and overall quality of life for individuals living with advanced PD.1

Clinical Evidence Supporting ONAPGO

The FDA approval of ONAPGO is based on robust clinical data from the Phase III TOLEDO study (NCT02006121), a 12-week, multicenter, double-blind, randomized, placebo-controlled trial involving 107 participants with advanced PD who experienced at least two hours of OFF time per day despite optimized oral treatments. The study evaluated the efficacy and safety of ONAPGO in reducing daily OFF time and increasing GOOD ON time, defined as periods of effective symptom control without troublesome dyskinesia.4

Key findings from the trial include a significant reduction in OFF time among patients treated with ONAPGO, who experienced a 2.6-hour reduction compared to a 0.9-hour reduction in the placebo group. Additionally, ONAPGO-treated patients reported a 2.8-hour increase in GOOD ON time, compared to 1.1 hours in the placebo group. A remarkable 79% of ONAPGO-treated patients reported improvement in their general health status, compared to just 24% in the placebo group.1

The therapy was well-tolerated, with the most common adverse events being infusion-site nodules, nausea, somnolence, infusion-site erythema, dyskinesia, headache, and insomnia.1 These results align with previous evidence supporting the efficacy of apomorphine in managing motor fluctuations and highlight ONAPGO’s potential to revolutionize PD care.3

Implications for Parkinson’s Care

The approval of ONAPGO marks a significant breakthrough in the management of advanced PD. Continuous infusion devices like ONAPGO are increasingly recognized as vital tools for managing motor fluctuations, particularly in patients for whom oral medications are ineffective.5 By providing sustained relief from OFF episodes, ONAPGO empowers patients to regain independence, improve daily functioning, and reduce caregiver burden.

Moreover, the introduction of ONAPGO underscores the growing emphasis on personalized medicine within neurology. As researchers continue to explore novel mechanisms and delivery systems, the field moves closer to tailoring treatments to individual patient needs. Set for launch in the second quarter of 2025, ONAPGO has the potential to improve mobility, symptom predictability, and overall quality of life for patients with advanced PD.

Written by Ellie Jackson

Edited by Simon Ng and Henry Shippey

References

  1. Supernus Pharmaceuticals. Supernus Announces FDA Approval of ONAPGOTM (apomorphine hydrochloride) for Parkinson’s Disease. Available here. (Last accessed 12/02/2025).
  2. Parkinson’s Foundation. Understanding Parkinson’s: Statistics. Available here. (Last accessed 12/02/2025).
  3. Tanner CM. Examining the clinical and economic burden of OFF periods in Parkinson disease. American Journal of Managed Care. 2020 Oct 13;26(12).
  4. Katzenschlager R, Poewe W, Rascol O, et al. Apomorphine subcutaneous infusion in patients with Parkinson’s disease with persistent motor fluctuations (TOLEDO): a multicentre, double-blind, randomised, placebo-controlled trial. The Lancet Neurology. 2018 Sep;17(9):749-759.
  5. van Laar T, Chaudhuri KR, Antonini A, et al. Infusion therapies in the treatment of Parkinson’s disease. Journal of Parkinson’s Disease. 2023 Jul 25;13(5):641–657.