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FDA Approves Onapgo - Drugs.com
Before you start using Onapgo, tell your healthcare provider about all of your medical conditions, including: difficulty staying awake during the daytime • dizziness, fainting spells, or low blood pressure • asthma; allergies to any medicines containing sulfites • heart problems • a history of stroke or other brain problems;
SPN-830, now Onapgo, approved for advanced Parkinson’s disease
2 days ago · Onapgo’s approval was based on data from an European placebo-controlled Phase 3 study (NCT02006121) called TOLEDO that indicated continuous apomorphine infusions reduced off time and increased on time, when symptoms are adequately controlled, among patients who were experiencing multiple hours of daily off time with levodopa-based treatment ...
Supernus Announces FDA Approval of ONAPGO ... - Markets Insider
1 day ago · During the Phase 3 study, ONAPGO significantly reduced the amount of daily OFF time at 12 weeks from baseline (p=0.0114), with ONAPGO-treated patients (n=53) experiencing a 2.6-hour reduction ...
Supernus' Parkinson's pump Onapgo finally lands FDA approval
1 day ago · Onapgo is a wearable pump designed to provide a continuous subcutaneous infusion of Supernus’ apomorphine (Apokyn). The drug is meant to allow patients more control over their daily "off" time ...
FDA Approves ONAPGO Apomorphine Hydrochloride For …
1 day ago · ONAPGO is the first and only subcutaneous apomorphine infusion device designed to deliver continuous treatment throughout the waking day, providing consistent control of OFF time, which is a ...
Onapgo (apomorphine hydrochloride infusion) | Parkinson's Disease
Because Onapgo is delivered continuously through an under-the-skin infusion, the medication bypasses the gastrointestinal track and directly enters the brain, stimulating dopamine receptors — potentially leading to more predictable symptom improvement. Researchers evaluated Onapgo in the Phase III TOLEDO clinical trial.
FDA Approves First Subcutaneous Apomorphine Device for …
1 day ago · Onapgo, a subcutaneous apomorphine infusion device, is approved for advanced Parkinson's disease, offering continuous symptom management without surgery. The TOLEDO trial showed apomorphine ...
US approves "milestone" Parkinson's treatment for 2025 release
21 hours ago · In trial, Onapgo – formerly known as SPN-830 – significantly reduced these daily off episodes by an average of 2.47 hours, compared to the placebo treatment (0.58 hours).
U.S. FDA approves Supernus' drug-device combination for …
1 day ago · The treatment branded Onapgo will be available in the U.S. in the second quarter. The drug regulator's greenlight brings an end in the company's years-long effort to market the pump-based ...
FDA approves Supernus’ Onapgo to treat advanced Parkinson’s …
16 hours ago · Onapgo, which is expected to be available in the second quarter of 2025, is a wearable subcutaneous infusion device that provides continuous treatment with the dopamine agonist apomorphine to help reduce ‘off’ time. Because Onapgo is delivered subcutaneously, the drug bypasses the gastrointestinal tract and directly enters the brain ...
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