Supernus wins FDA approval for ONAPGO, a continuous infusion therapy for Parkinson’s disease

The U.S. Food and Drug Administration (FDA) has granted approval to Supernus Pharmaceuticals, Inc. for ONAPGO (apomorphine hydrochloride) injection, marking a milestone in Parkinson’s disease management. ONAPGO is the first and only continuous infusion therapy available in the U.S. for treating motor fluctuations in adults with advanced Parkinson’s disease (PD).

This wearable, subcutaneous infusion device delivers apomorphine hydrochloride throughout the waking hours, offering patients a non-invasive alternative to address the unpredictable “OFF” episodes associated with disease progression. Supernus Pharmaceuticals plans to launch ONAPGO in the second quarter of 2025, alongside a patient support program aimed at enhancing accessibility and treatment adherence.

How Does ONAPGO Improve Parkinson’s Disease Management?

For patients with advanced Parkinson’s disease, managing motor fluctuations remains a persistent challenge. As the disease progresses, levodopa-based therapies often become less effective due to irregular absorption and gastrointestinal (GI) motility issues. This inconsistency results in alternating ON and OFF periods, where symptoms fluctuate between controlled and uncontrolled states.

Unlike oral treatments, ONAPGO delivers continuous infusion therapy directly via a subcutaneous pump, bypassing the GI tract and allowing for more predictable symptom control. By providing stable dopamine receptor stimulation, ONAPGO helps reduce the frequency and severity of OFF episodes, potentially transforming the way patients manage daily fluctuations.

What Do Clinical Trials Reveal About ONAPGO’s Effectiveness?

The FDA’s approval is backed by a Phase 3 clinical trial, which evaluated the efficacy and safety of ONAPGO in 107 patients over a 12-week period. The results demonstrated a significant reduction in OFF time, with ONAPGO-treated patients experiencing an average 2.6-hour decrease in daily OFF time, compared to 0.9 hours in the placebo group.

In addition to minimizing OFF episodes, patients using ONAPGO reported an increase in GOOD ON time—the period when medication effectively controls symptoms without inducing troublesome dyskinesia. ONAPGO patients gained an additional 2.8 hours of GOOD ON time daily, compared to a 1.1-hour improvement in the placebo group.

Dr. Rajesh Pahwa, Director of the Movement Disorder Program at The University of Kansas Health System and a clinical trial investigator, emphasized that continuous infusion therapy has been widely used in Europe for decades. He noted that ONAPGO now provides U.S. patients with an advanced treatment option designed to improve symptom predictability without the need for surgical intervention.

Why Is Continuous Infusion Therapy a Game-Changer?

The approval of ONAPGO represents a critical advancement in Parkinson’s disease management, addressing the limitations of traditional levodopa therapy. Since levodopa absorption fluctuates due to delayed gastric emptying and erratic metabolism, patients often experience inconsistent symptom relief.

Dr. Stuart Isaacson, Director of the Parkinson’s Disease and Movement Disorders Center of Boca Raton, highlighted how apomorphine hydrochloride directly stimulates dopamine receptors, offering a more reliable alternative to pulsatile oral dopamine therapies. Because ONAPGO is delivered via subcutaneous infusion, it bypasses the digestive system entirely, allowing for steady drug absorption and more consistent motor control.

For many patients, this shift from intermittent dosing to continuous delivery could mean fewer unexpected OFF episodes, improving their ability to engage in daily activities with greater confidence.

How Will ONAPGO Impact Parkinson’s Patients in the U.S.?

The unpredictability of ON and OFF states is one of the most disruptive aspects of living with Parkinson’s disease. Andrea Merriam, CEO of the Parkinson & Movement Disorder Alliance, explained that these fluctuations can interfere with work, mobility, and social interactions, making it difficult for patients to plan their daily lives.

By introducing a wearable and non-invasive alternative, ONAPGO offers a new level of symptom stability, providing an option for patients who do not respond well to existing treatments. Unlike deep brain stimulation (DBS), which requires surgical implantation, ONAPGO is a portable infusion device that allows for continuous dopamine receptor stimulation without invasive procedures.

Supernus Pharmaceuticals CEO Jack Khattar reaffirmed the company’s commitment to CNS innovation, stating that ONAPGO is part of their broader strategy to develop breakthrough therapies for neurological disorders.

What Are the Potential Side Effects of ONAPGO?

While ONAPGO presents a promising new option for motor fluctuations treatment, it is important for patients to discuss potential side effects with their healthcare providers.

Clinical trials identified the most common adverse events associated with ONAPGO, including infusion-site nodules, nausea, somnolence, erythema, dyskinesia, headache, and insomnia. These side effects were observed in at least 10% of trial participants but were generally manageable with appropriate treatment adjustments.

Since ONAPGO bypasses the digestive tract, it may also reduce the gastrointestinal side effects commonly associated with oral Parkinson’s medications.

When Will ONAPGO Be Available?

Supernus Pharmaceuticals has confirmed that ONAPGO will be available in the U.S. market by Q2 2025. The company plans to launch a comprehensive patient support program, ensuring that both healthcare providers and patients have access to education, training, and reimbursement assistance.

As demand for non-invasive Parkinson’s disease management solutions grows, ONAPGO’s approval signals a new era of treatment innovation, offering a much-needed alternative for individuals struggling with unpredictable motor fluctuations.