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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;
ONAPGO: A Newly-Approved Medication for OFF Periods in …
2 days ago · ONAPGO TM: A Newly-Approved Medication for OFF Periods in Parkinson’s. Breaking News! The first subcutaneous (under the skin) apomorphine infusion, now called ONAPGO TM, was approved by the Food and Drug Administration (FDA) on February 4, 2025. Apomorphine is a dopamine agonist whose effects have a rapid onset.
ONAPGO initiation and dose titrations should be done under medical supervision. • The prescribed dose of ONAPGO should be expressed in “mg/hr” for the continuous dosage and “mg” for an extra dose. 2.2 . Premedication and Concomitant Medication
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.
SPN-830, now Onapgo, approved for advanced Parkinson’s disease
3 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 ...
FDA Approves Wearable Infusion Device for Advanced Parkinson …
1 day ago · The efficacy and safety of Onapgo were determined in a phase 3, 12-week, multicenter, parallel-group, double-blind, randomized, placebo-controlled study involving 107 patients. At 12 weeks from baseline, patients using Onapgo (compared with placebo) experienced a significantly reduced amount of daily OFF time (reduction of 2.6 versus 0.9 hours).
Supernus Pharmaceuticals Announces FDA Approval of ONAPGO, …
3 days ago · ONAPGO is a wearable subcutaneous infusion device that provides continuous treatment during the waking day for more consistent control of OFF time ONAPGO will be available in the U.S. in second ...
FDA Approves Onapgo for Advanced Parkinson Disease
1 day ago · The efficacy and safety of Onapgo were determined in a phase 3, 12-week, multicenter, parallel-group, double-blind, randomized, placebo-controlled study involving 107 patients. At 12 weeks from baseline, patients using Onapgo (compared with placebo) experienced a significantly reduced amount of daily OFF time (reduction of 2.6 versus 0.9 hours
FDA Approves First Subcutaneous Apomorphine Device for …
2 days 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 ...
FDA OKs New Wearable Infusion Device for Parkinson’s - WebMD
1 day ago · Onapgo is a small lightweight device that delivers apomorphine directly into the bloodstream, bypassing the digestive system. It mimics dopamine to help manage Parkinson’s symptoms, providing a ...
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