SPN-830 FDA Approval Status

Last updated by Judith Stewart, BPharm on April 8, 2024.

FDA Approved: No
Brand name: SPN-830
Generic name: apomorphine
Dosage form: Infusion Device
Company: Supernus Pharmaceuticals, Inc.
Treatment for: Hypomobility in Parkinson’s Disease

SPN-830 (apomorphine) is a continuous subcutaneous infusion formulation of the approved dopamine agonist apomorphine in development for the treatment of motor fluctuations (OFF episodes) in Parkinson’s disease (PD).

OFF periods in patients with Parkinson’s disease are periods of hypomobility that result from low levels of dopamine between scheduled doses of levodopa and unpredictable episodes associated with advanced Parkinson’s disease.
Apomorphine works as a dopamine agonist that binds with high affinity to the dopamine D₄ receptor, and moderate affinity for the dopamine D₂, D₃, and D₅, and adrenergic α₁D, α₂B, α₂C receptors. The way in which apomorphine works as a treatment for Parkinson’s disease is believed to be due to stimulation of post-synaptic dopamine D₂-type receptors within the caudate-putamen in the brain.
Apomorphine was first approved in 2004 under the brand name Apokyn for the acute, intermittent treatment of OFF episodes in Parkinson’s disease. Apokyn is administered by subcutaneous injection with a multiple-dose pen injector that can be used up to five times a day, with doses no less than two hours apart.
SPN-830 provides a continuous subcutaneous infusion of apomorphine through an infusion device.
The New Drug Application (NDA) for SPN-830 was submitted to the FDA in September 2020 supported by data from the Phase III TOLEDO study which demonstrated a statistically significant reduction in mean daily OFF time compared with placebo.
A Complete Response Letter (CRL) was issued by the FDA in October 2022, and the NDA resubmitted in October 2023. It was announced that the NDA had been accepted for review by the FDA in November 2023 with a prescription drug user fee act goal date (PDUFA date) of April 5, 2024.
On April 8, 2024, Supernus Pharmaceuticals announced that the FDA had issued another Complete Response Letter. The CRL mentioned two areas requiring additional review by the FDA or additional information to be provided to the FDA. No clinical safety or efficacy issues were identified as a requirement for approval.

Development timeline for SPN-830

Date	Article
Apr 8, 2024	Supernus Provides Regulatory Update for SPN-830
Nov 2, 2023	Supernus Announces SPN-830 Apomorphine Infusion Device NDA Accepted for Review by FDA
Oct 9, 2023	Supernus Resubmits NDA for SPN-830 Apomorphine Infusion Device
Oct 10, 2022	Supernus Provides Regulatory Update on SPN-830
Dec 8, 2021	Supernus Resubmits NDA for SPN-830 Apomorphine Infusion Device
Sep 14, 2020	Supernus Submits NDA for SPN-830 for Continuous Treatment of ON-OFF Episodes in Adults with Parkinson’s Disease Who Have Failed Two Treatments

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer