Apomorphine Infusion Device Onapgo Approved for Parkinson Disease

The Food and Drug Administration (FDA) has approved Onapgo™ (apomorphine hydrochloride [HCl]) for the treatment of motor fluctuations (“off” episodes) in adults with advanced Parkinson disease (PD).

Onapgo is a wearable subcutaneous (SC) infusion device that delivers apomorphine, a non-ergoline dopamine agonist, on a continuous basis. Apomorphine is believed to treat “off” episodes associated with PD through stimulation of postsynaptic dopamine D₂-type receptors within the caudate-putamen in the brain.

“With Onapgo, the continuous infusion of apomorphine directly stimulates postsynaptic dopamine receptors with no metabolic conversion needed,” said Stuart Isaacson, MD, Director of Parkinson’s Disease and Movement Disorders Center of Boca Raton, Florida, and a clinical trial investigator for Onapgo. “In addition, the subcutaneous delivery of apomorphine bypasses the GI tract and enters the brain, which can allow for more predictable symptom improvement.”

The approval was based on data from the phase 3 TOLEDO study (ClinicalTrials.gov Identifier: NCT02006121), which included adults with PD whose motor fluctuations were not adequately controlled on carbidopa/levodopa and other concomitant medications (eg, dopamine agonists, catechol-O-methyltransferase inhibitors, monoamine oxidase B inhibitors, amantadine). Study participants were randomly assigned to receive Onapgo (n=53) or placebo (n=51) for 12 weeks. 

At baseline, patients experienced “off” episodes averaging at least 3 hours per day. The primary endpoint was the change from baseline to week 12 in mean daily “off” time over 24 hours based on patient diaries. 

Findings showed treatment with Onapgo resulted in a statistically significant reduction in mean daily “off” time compared with placebo (2.6 hours vs 0.9 hours; treatment difference, -1.65 [95% CI, -2.91, -0.38]; P =.0114). A significant increase in daily “on” time without troublesome dyskinesia was also observed with Onapgo vs placebo (2.8 hours vs 1.1 hours; treatment difference, 1.64 [95% CI, 0.28-3.00]; P =.0188). 

Additionally, a significantly greater percentage of patients treated with Onapgo reported improvement in their general state of health (measured by the Patient Global Impression of Change scale) compared with those who received placebo (79% vs 24%; P <.0001).

The most common adverse reactions reported with Onapgo were infusion-site nodule, nausea, somnolence, infusion-site erythema, dyskinesia, headache, and insomnia. 

Onapgo is supplied in single-dose cartridges containing 98mg/20mL of apomorphine HCl. It is administered as an SC infusion with the Onapgo pump. Patients should receive training on the proper use of the delivery device prior to starting treatment. The product is expected to be available in the second quarter of 2025. 

This article originally appeared on MPR