Neurology
Partner With Us
Advertisement
Conexiant chevron_right Neurology chevron_right FDA Approves New Drug-Device Combo for Parkinsons Symptoms
FDA & Government News

FDA Approves New Drug-Device Combo for Parkinson’s Symptoms

The U.S. Food and Drug Administration has approved Onapgo, a continuous apomorphine hydrochloride infusion, for the treatment of motor fluctuations in adult patients with advanced Parkinson’s disease.

Conexiant
article Full Article subject Summary summarize Notecard
  1. Onapgo, an apomorphine hydrochloride injection, has received FDA approval for treating movement-related symptoms in Parkinson’s disease.
  2. The drug-device combination demonstrated a statistically significant reduction in daily 'off episode' duration and an increase in daily 'good on' time.
  3. The approval was supported by findings from the phase III TOLEDO trial.
  4. Onapgo delivers apomorphine continuously via subcutaneous infusion, offering an alternative to currently available apomorphine injections.
  5. Onapgo may have a favorable tolerability profile relative to AbbVie’s Vyalev, with fewer injection site reactions and skin nodules.
  6. Commercial availability is anticipated in the second quarter of 2025.
  7. Long-term safety data and head-to-head comparisons with other therapies were not included in the announcement.

Daily News

Stay up to date with the latest clinical headlines and other information tailored to your specialty.