The Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) target date for SPN-830, an apomorphine infusion device for the continuous treatment of motor fluctuations (off episodes) in adults with Parkinson disease.

Apomorphine, a non-ergoline dopamine agonist, is believed to treat off episodes associated with Parkinson disease through stimulation of postsynaptic dopamine D2-type receptors within the caudate-putamen in the brain. SPN-830 provides a continuous subcutaneous infusion of apomorphine through an infusion pump. 

Supernus had originally submitted the NDA for SPN-830 in September 2020. The application included data from the phase 3 TOLEDO study (ClinicalTrials.gov Identifier: NCT02006121) and a supportive open-label study (ClinicalTrials.gov Identifier: NCT02339064). The FDA subsequently issued a Refusal to File (RTF) letter stating that the NDA was not sufficiently complete to permit a substantive review.

In December 2021, the Company resubmitted the NDA after the Agency provided additional guidance related to the requested documents and reports cited in the RTF letter.

A Prescription Drug User Fee Act (PDUFA) target date of early October 2022 has now been set for the application. According to the Company, if approval is granted, the product may launch in the first quarter of 2023.

References

  1. Supernus receives notice assigning early October 2022 PDUFA for SPN-830 apomorphine infusion device NDA. News release. Supernus Pharmaceuticals, Inc. Accessed February 22, 2022. https://www.globenewswire.com/news-release/2022/02/22/2389258/19871/en/Supernus-Receives-Notice-Assigning-Early-October-2022-PDUFA-for-SPN-830-Apomorphine-Infusion-Device-NDA.html.
  2. Supernus resubmits NDA for SPN-830 apomorphine infusion device. News release. Supernus Pharmaceuticals, Inc. December 8, 2021. Accessed February 22, 2022. https://ir.supernus.com/news-releases/news-release-details/supernus-resubmits-nda-spn-830-apomorphine-infusion-device.
  3. Supernus provides regulatory updates for SPN-812 and SPN-830. News release. Supernus Pharmaceuticals, Inc. November 9, 2020. Accessed February 22, 2022. https://ir.supernus.com/news-releases/news-release-details/supernus-provides-regulatory-updates-spn-812-and-spn-830.