Supernus Pharmaceuticals, Inc. (SUPN), a biopharmaceutical company, announced on Tuesday the FDA approval of ONAPGO or apomorphine hydrochloride for the treatment of motor fluctuations in adults with advanced Parkinson's disease or PD.
ONAPGO is the first and only subcutaneous apomorphine infusion device designed to deliver continuous treatment throughout the waking day, providing consistent control of OFF time, which is a common challenge for Parkinson's patients.
The approval follows positive results from a Phase 3 study showing ONAPGO significantly reduced daily OFF time and increased GOOD ON time compared to placebo.
This treatment offers a new option for patients who struggle with oral medications, such as levodopa, as Parkinson's progresses and becomes harder to manage.
ONAPGO will be available in the U.S. by the second quarter of 2025, supported by a nurse education program and access assistance.
This approval is a significant step forward in providing patients with more reliable symptom management and improving their quality of life.
Currently, SUPN is trading at $39.61 up by 5.81%.
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