United States: Supernus Pharmaceuticals released news about the US Food and Drug Administration (FDA) approving Onapgo (apomorphine hydrochloride) injection as the first and only subcutaneous apomorphine infusion device to treat advanced Parkinson’s disease motor fluctuations.
More about the news
The Onapgo device represents the sole wearable subcutaneous apomorphine infusion device that provides steady motor fluctuation control for continuous wake-day motor fluctuation management to patients.
The medical market will receive Onapgo starting in the second quarter of 2025. Specialist personnel have formed a plan to create a comprehensive nurse educational program for the product launch.
Resolution of efficacy and safety for Onapgo emerged from a multicenter phase 3 trial that ran for 12 weeks using double-blind methods to analyze placebo and Onapgo outcomes with 107 test subjects.
Study details
Patients who used Onapgo (compared with placebo) achieved two and a half hours lower daily OFF time (reduction of 2.6 versus 0.9 hours) measurements than those receiving placebo at the 12-week baseline period.
An increase in GOOD ON time duration reached 2.8 hours compared to the initial 1.1 hours during daily observations.
Preliminary improvements in OFF and GOOD ON duration started within the first treatment week and then remained stable until all measurement points were reached.
The most reported adverse reactions (affecting more than ten percent of patients) included both infusion-site nodules and nausea alongside excessive sleepiness yet infusion-site skin irritation, headache, and insomnia.
According to Andrea Merriam, CEO of the Parkinson & Movement Disorder Alliance in Phoenix, “As the motor symptoms of Parkinson’s disease worsen over time, patients report alternating states between ON when their medication is working, and OFF when it’s not working optimally,” US News reported.
Furthermore, “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. For many, continuous treatment options like Onapgo can help to make days with Parkinson’s more predictable.”