The U.S. Food and Drug Administration (FDA) has approved Onapgo (apomorphine hydrochloride) injection, a wearable subcutaneous infusion device for individuals with advanced Parkinson's disease. This marks the first and only such device available for managing motor fluctuations, a common symptom as the disease progresses.
Onapgo delivers a continuous supply of apomorphine, a medication that helps reduce OFF time, periods when Parkinson's medication stops working, leading to symptom recurrence. Unlike traditional oral medications, this wearable pump ensures consistent medication levels throughout waking hours, minimizing fluctuations and providing more stable symptom control.
Supernus Pharmaceuticals, the developer of Onapgo, anticipates the device's availability in the second quarter of 2025. To support patients, the launch will include a team of specialists and a nurse education program to facilitate training and proper device usage.
The FDA's approval is based on a 12-week phase 3 clinical trial involving 107 patients. The trial employed a double-blind, placebo-controlled design, meaning neither doctors nor patients knew who received the actual treatment. The study compared Onapgo's effects to a placebo (a treatment without active medication).
The results showed a significant reduction in daily OFF time for patients using Onapgo compared to the placebo group. However, some patients reported side effects, including nausea, somnolence, and infusion-site reactions.
Onapgo represents a significant advancement in Parkinson's treatment by offering a continuous and wearable solution for managing motor fluctuations. This could lead to improved quality of life for patients by making daily activities more predictable and manageable.