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FDA approved Onapgo (apomorphine) for Motor Fluctuations in Advanced Parkinson'sFDA approved Onapgo for motor fluctuations in advanced Parkinson's disease.

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Key Takeaway
Consider Onapgo for advanced Parkinson's patients with motor fluctuations, but ensure premedication with trimethobenzamide and avoid 5HT3 antagonists.

The FDA has approved Onapgo (apomorphine hydrochloride) for the treatment of motor fluctuations in adults with advanced Parkinson's disease. Onapgo is a dopaminergic agonist administered as a continuous subcutaneous infusion, intended for patients who experience OFF episodes despite optimized oral therapy. The approval provides a new option for managing motor complications in advanced disease. The label does not include specific clinical trial data, but the recommended dosing and safety information are detailed. Onapgo is not substitutable for intermittent apomorphine products. Clinicians should note the requirement for premedication with trimethobenzamide to reduce nausea and vomiting, and the contraindication with 5HT3 antagonists due to risk of hypotension and loss of consciousness.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Apomorphine is a non-ergoline dopamine agonist with high affinity for dopamine D4 receptors, and moderate affinity for dopamine D2, D3, D5, and adrenergic α1D, α2B, α2C receptors. The precise mechanism of action in Parkinson's disease is unknown, but it is thought to be due to stimulation of postsynaptic dopamine D2-type receptors within the caudate-putamen in the brain.

Indication & Patient Population

Onapgo is indicated for the treatment of motor fluctuations in adults with advanced Parkinson's disease.

Dosing & Administration

Onapgo is for subcutaneous use by infusion only. The recommended initial continuous dosage is 1 mg/hr, with a maximum of 6 mg/hr for up to 16 hours per day. Extra doses may be used as a loading dose or for acute OFF symptoms, titrated in 0.5 mg or 1 mg increments, with subsequent extra doses between 0.5 mg and 2 mg, at least 3 hours apart, up to 3 extra doses per day. Maximum total daily dosage is 98 mg. Premedication with trimethobenzamide 300 mg three times daily is recommended starting 3 days prior to first dose, continued no longer than 2 months. For mild or moderate renal impairment, initial extra dose is 0.5 mg to 1 mg, not exceeding 1 mg.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Contraindicated with concomitant use of 5HT3 antagonists (e.g., ondansetron, granisetron, dolasetron, palonosetron) and alosetron due to risk of profound hypotension and loss of consciousness. Warnings include nausea and vomiting, somnolence, dizziness, and falls, especially with trimethobenzamide. Not substitutable for intermittent apomorphine products.

Place in Therapy

Onapgo provides a continuous dopaminergic stimulation option for advanced Parkinson's disease patients with motor fluctuations not adequately controlled by oral medications. It requires careful patient selection, training on the infusion device, and monitoring for adverse effects. Its role is similar to other apomorphine infusions but with a specific delivery system.

The FDA has approved a new drug called Onapgo (apomorphine hydrochloride) for adults with advanced Parkinson's disease. It is used to treat motor fluctuations, which are times when Parkinson's symptoms return or worsen between doses of oral medication. Onapgo is given as a continuous infusion under the skin, using a pump. This approval offers a new treatment option for people who still have OFF episodes even when their current oral therapy is optimized.

Onapgo is for patients with advanced Parkinson's disease who experience motor fluctuations. It is not meant for people with earlier stages of the disease or for those who do not have OFF episodes. The drug works by stimulating dopamine receptors in the brain, which helps improve movement control. Before starting Onapgo, patients must take a medicine called trimethobenzamide to reduce nausea and vomiting. Onapgo should not be used with certain anti-nausea drugs called 5HT3 antagonists because this combination can cause low blood pressure and loss of consciousness.

This approval means there is now another choice for managing motor complications in advanced Parkinson's disease. However, Onapgo is not interchangeable with other apomorphine products that are given as injections for sudden OFF episodes. The dosing and safety information are provided in the drug label. Patients and caregivers should talk to their doctor to see if Onapgo is right for them and to understand how to use the infusion pump properly.

What this means for you:
Onapgo is a new continuous infusion option for advanced Parkinson's motor fluctuations, but it is not a substitute for other apomorphine products.

Study Details

Study typeFda approval
PublishedFeb 2025
View Original Abstract ↓
1 INDICATIONS AND USAGE ONAPGO is indicated for the treatment of motor fluctuations in adults with advanced Parkinson's disease. ONAPGO is a dopaminergic agonist indicated for the treatment of motor fluctuations in adults with advanced Parkinson's disease. ( 1 )
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