Supernus Pharmaceuticals Secures FDA Approval for Parkinson's Drug-Device Combo Onapgo

Supernus Pharmaceuticals has finally secured FDA approval for its apomorphine hydrochloride injection, Onapgo, a drug-device combination designed to treat motor fluctuations in adults with Parkinson's disease. This approval marks the end of a challenging regulatory journey and opens up a potentially lucrative market opportunity for the company.

FDA Approval and Market Potential

The U.S. Food and Drug Administration (FDA) greenlit Onapgo on Tuesday, granting Supernus access to a U.S. market opportunity estimated by Jefferies analysts to be worth between $100 million and $300 million. Supernus plans to launch Onapgo in the second quarter of this year, with pricing expected to be comparable to AbbVie's similar product, Vyalev, which has an annual wholesale acquisition cost of approximately $119,000.

Onapgo is a continuous subcutaneous infusion system for apomorphine, indicated for the treatment of motor fluctuations in Parkinson's disease patients. The drug's label includes safety precautions for patients taking certain nausea medications and those with allergies to the infusion's ingredients.

Clinical Efficacy and Regulatory Challenges

The FDA's decision was supported by data from a Phase III trial involving 107 patients. The study demonstrated that Onapgo significantly reduced daily off time and increased daily good on time in patients with Parkinson's disease. These benefits were observed as early as one week after treatment initiation and persisted throughout the study.

However, the road to approval was not smooth for Supernus. The FDA rejected Onapgo twice before granting approval:

1. In October 2022, the agency cited the need for additional information about the infusion device and further analysis of the drug product. The FDA identified deficiencies in labeling, product quality, risk analysis, and manufacturing.

2. In April 2024, the FDA issued a Complete Response Letter, requesting additional information on product quality and the infusion device. Notably, the regulator did not raise concerns about the drug's clinical safety or efficacy at this time.

Market Positioning and Competitive Landscape

While Onapgo enters a market with existing competitors like AbbVie's Vyalev, Jefferies analysts suggest that Supernus's product may have some distinguishing factors. These include a potentially better tolerability profile and a different mechanism of action, which could be advantageous as patients progress in their disease.

Supernus CEO Jack Khattar emphasized the novel approach Onapgo offers to prescribers treating adults with Parkinson's disease experiencing motor fluctuations. As the company prepares for the product launch, the pharmaceutical industry will be watching closely to see how Onapgo performs in this competitive landscape.