Onapgo is the primary and solely wearable subcutaneous apomorphine infusion gadget that gives steady therapy throughout the waking day, providing sufferers extra constant management of motor fluctuations. The product is anticipated to be obtainable within the second quarter of 2025. The launch can be supported by a crew of specialists, together with a sturdy nurse training program.
The efficacy and security of Onapgo have been decided in a part 3, 12-week, multicenter, parallel-group, double-blind, randomized, placebo-controlled examine involving 107 sufferers. At 12 weeks from baseline, sufferers utilizing Onapgo (in contrast with placebo) skilled a considerably decreased quantity of each day OFF time (discount of two.6 versus 0.9 hours). This discovering was accompanied by a major enhance in each day GOOD ON time (2.8 versus 1.1 hours). Better enhancements in each day OFF and GOOD ON instances have been seen as early as the primary week of therapy and have been maintained all through all measured time factors. Generally reported antagonistic occasions (≥10 % incidence) included infusion-site nodule, nausea, extreme sleepiness, infusion-site pores and skin irritation, headache, and insomnia.
“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,” Andrea Merriam, CEO of the Parkinson & Motion Dysfunction Alliance in Phoenix, stated in an announcement. “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.”
Approval of Onapgo was granted to Supernus Prescribed drugs.
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FDA approves wearable infusion gadget for superior Parkinson illness (2025, February 6)
retrieved 6 February 2025
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