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Edited by: TJVNews.com
In a significant development for the treatment of advanced Parkinson’s disease, the U.S. Food and Drug Administration (FDA) has approved Onapgo (apomorphine hydrochloride) injection, marking the first and only subcutaneous apomorphine infusion device designed to manage motor fluctuations. As HealthDay News reported, this novel treatment—developed by Supernus Pharmaceuticals—offers continuous symptom control during waking hours, providing a new level of consistency for patients struggling with the unpredictable nature of the disease.
According to the information provided in the HealthDay News report, Onapgo represents a groundbreaking shift in Parkinson’s treatment, as it is the first wearable subcutaneous apomorphine infusion device to offer sustained relief from motor fluctuations. Unlike traditional medication regimens that may leave patients alternating between effective symptom control and debilitating OFF periods, this device is designed to provide continuous drug delivery throughout the day. Supernus Pharmaceuticals has announced that Onapgo is expected to be commercially available in the second quarter of 2025 and will be supported by a team of specialists, including a dedicated nurse education program to assist patients with its use.
The efficacy and safety of Onapgo were rigorously evaluated in a phase 3, 12-week, multicenter, parallel-group, double-blind, randomized, placebo-controlled study involving 107 patients with advanced Parkinson’s disease. As the HealthDay News report detailed, the results demonstrated a significant reduction in daily OFF time among patients using Onapgo, with an average reduction of 2.6 hours, compared to 0.9 hours in the placebo group. Additionally, patients reported an increase in daily GOOD ON time, with an average improvement of 2.8 hours, compared to 1.1 hours in those receiving the placebo.
As noted by HealthDay News, these improvements were observed as early as the first week of treatment and remained consistent throughout the entire study period. This rapid and sustained efficacy highlights Onapgo’s potential to transform the quality of life for Parkinson’s patients who experience frequent fluctuations in their medication’s effectiveness. However, like any medical treatment, Onapgo is not without side effects. The most commonly reported adverse events—each occurring in at least 10% of patients—included infusion-site nodules, nausea, excessive sleepiness, infusion-site skin irritation, headache, and insomnia. Despite these potential drawbacks, the benefits of greater symptom control and predictability in daily function may outweigh the risks for many patients.
The importance of minimizing OFF periods in Parkinson’s disease cannot be overstated. As the HealthDay News report highlighted, Andrea Merriam, CEO of the Parkinson & Movement Disorder Alliance in Phoenix, emphasized how disruptive ON-OFF fluctuations can be for patients. She explained that these unpredictable changes—where medication alternates between effectiveness and ineffectiveness—can significantly impact a patient’s ability to engage in daily activities. “These on-again, off-again changes are disruptive and can happen at any time, which is why consistent daily control of OFF time is key to improving how patients feel and move,” Merriam said, as reported by HealthDay News. She added that continuous treatment options like Onapgo have the potential to make life more manageable for individuals living with Parkinson’s.
The FDA’s approval of Onapgo marks a major milestone in the field of movement disorder treatment. As HealthDay News reported, Supernus Pharmaceuticals secured this approval after years of research and development, and the upcoming launch will be accompanied by a structured rollout strategy to ensure healthcare professionals and patients are well-informed about the device’s benefits and proper usage. Given its potential to significantly improve symptom stability, Onapgo is expected to be a valuable new tool for clinicians treating patients with advanced Parkinson’s disease.
