The US Food and Drug Administration has approved Onapgo (Apomorphine Hydrochloride) Injection as the first and only subcutaneous apomorphine infusion device for the treatment of motor forth On disease, according to a news from supernus pharmaceuticals.
Onapgo is the first and only wearable subcutaneous apomorphine infusion device that provides continuous treatment during the waking day, offering patients more conference more contemporary floastations. The product is expected to be available in the second Quarter of 2025. The launch will be supported by a team of experts, Including a Robust Nuse Education Program.
The efficacy and safety of onapgo was determined in a phase 3, 12-wheelk, multicenter, parallel-group, double-light-light, randomized, placebo-contelled study 107 patients. At 12 weeks from baseline, patients using onapgo (compared with placebo) experienced a significant a significantly reduced Amount of daily off time (Reduction of 2.6 Versus 0.9 hours). This finding was accounted by a significant increase in daily good on time (2.8 versus 1.1 hours). Greater improvements in daily off and good on time we see as early as the first week of treatment and ware mained throughout all measured time points. Commonly reported Adverse Events (≥10 Percent Incidence) Included Infusion Nodule, Nausea, Excessive Sleepiness, Infusion Skin Irritation, Headache, and insominia.
“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 is not working optimally,” & Movement disorder alliance in Phoenix, said in a Statement. “These on -gain, off -gain changes are disruptive and can happy at any time, which is who is consistent daily control of off time is key to improving how patients Feel and Movie. Like onapgo can help to make Days With Parkinson’s More Predictable. “
Approval of onapgo was granted to supernus pharmaceuticals.
More information:
More information
Copyright © 2025 HealthdayAll rights reserved.
Citation: FDA Approves Wearable Infusion Device for Advanced Parkinson Disease (2025, February 6) Retrieved 6 February 2025 from
This document is Subject to copyright. Apart from any Fair Dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.
(Tagstotranslate) Medicine Research News (T) Medicine Research (T) Health Research News (T) Health Research (T) Health Science (T) Medicine Science