An apomorphine hydrochloride injection, formerly known as SPN-830, reduced daily "off episode" duration in adult patients with advanced Parkinson’s disease by more than 2 hours compared to less than 1 hour with placebo.

Supernus Pharmaceuticals' drug-device combination, Onapgo, received approval from the U.S. Food and Drug Administration (FDA) for the treatment of movement-related symptoms in patients with Parkinson’s disease (PD) following prior regulatory delays, according to a company press release. Onapgo delivers apomorphine continuously via subcutaneous infusion, offering an alternative to currently available apomorphine injections that require administration every 2 hours. 

The approval was supported by findings from the phase III TOLEDO trial, which evaluated the agent's efficacy in reducing "off episodes" and their duration among patients with PD. The study population included patients experiencing motor fluctuations inadequately controlled with standard therapy. At 12 weeks from baseline, Onapgo demonstrated a statistically significant reduction in daily "off episode" duration by a mean of 2.6 hours compared to 0.9 hours with placebo, and also showed an increase daily "good on" time (2.8 hours with Onapgo vs 1.1 hours with placebo). 

Apomorphine is used to treat symptoms such as tremors and difficulty walking in patients with PD, helping to reduce "off episodes" when medication effects diminish. Notably, analysts have suggested that Onapgo may have a favorable tolerability profile relative to AbbVie’s Vyalev, a pump-based carbidopa-levodopa therapy approved in October 2023, as separate studies indicated fewer injection site reactions and skin nodules with the newer agent.

The company anticipates commercial availability in the second quarter of 2025. The announcement did not include data on long-term safety with Onapgo or head-to-head comparisons with other therapies.