Continuous, Subcutaneous Apomorphine Infusion Device Approved for Parkinson’s

The Food and Drug Administration (FDA) has approved the wearable Onapgo (apomorphine hydrochloride; Supernus Pharmaceuticals, Rockville, MD) subcutaneous injection device to treat motor fluctuations in adults with advanced Parkinson disease (PD). Onapgo enables continuous apomorphine infusion during waking hours and is designed to serve as a small, noninvasive, lightweight option for people who are not responding to other treatments. According to a statement from Supernus Pharmaceuticals, Onapgo bypasses the gastrointestinal absorption issues of oral levodopa and provides stable dopamine receptor stimulation to reduce OFF episodes. The company expects Onapgo to be available on the market in the second quarter of 2025.

The approval was based on data from the 12-week, multicenter, placebo-controlled, double-blind, phase 3 TOLEDO clinical trial (NCT02006121) which included 107 adult participants aged ≥30 years with PD. Participants were randomized to receive treatment with Onapgo 5 mg/mL solution or placebo. The primary endpoint was mean change from baseline in total daily OFF time at 12 weeks, as reported in patient diaries.

Key results include the following:

• Total daily OFF time reduced by 2.6 hours in people who received Onapgo treatment vs 0.9 hours with placebo (P=.0114).
• Daily GOOD ON time (time spent without troublesome dyskinesia) increased by 2.8 hours in participants who received Onapgo treatment vs 1.1 hours with placebo (P=.0188).
• Participants treated with Onapgo demonstrated a 79% increase in Patient Global Impression of Change (PGIC) scores vs 24% with placebo (P<.0001), suggesting improved general health.
• The most common adverse events (AEs) included infusion-site nodule, infusion-site erythema, nausea, somnolence, insomnia, dyskinesia, and headache, with no unexpected safety concerns.
• 6 participants treated with Onapgo withdrew from the study due to AEs, including visual hallucinations, moderate gait disturbances, mild infusion-site erythema, severe hypotension, myocardial infarction, and abnormal hematology results.

“As Parkinson’s disease progresses, levodopa treatment often becomes less effective at delivering consistent motor control in part due to GI dysmotility, variable absorption of oral medication, and the resulting pulsatile stimulation of dopamine pathways in the brain,” said Stuart Isaacson, MD, Onapgo clinical trial investigator and Director of the Parkinson’s Disease and Movement Disorders Center of Boca Raton, FL. “With ONAPGO, the continuous infusion of apomorphine directly stimulates postsynaptic dopamine receptors with no metabolic conversion needed. In addition, the subcutaneous delivery of apomorphine bypasses the GI tract and enters the brain, which can allow for more predictable symptom improvement.”