FDA Approves New Drug-Device Combo for Parkinson’s Symptoms
MDSpire News
February 4, 2025
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Onapgo, a drug-device combination, received FDA approval for treating movement-related symptoms in Parkinson’s disease.
The treatment reduced daily 'off episode' duration by a mean of 2.6 hours compared to 0.9 hours with placebo.
Onapgo delivers apomorphine continuously via subcutaneous infusion, unlike current injections requiring every 2 hours.
The approval was based on the phase III TOLEDO trial, which assessed efficacy in patients with motor fluctuations.
Analysts suggest Onapgo may have better tolerability than AbbVie’s Vyalev, with fewer injection site reactions.
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