FDA Issues Complete Response Letter to Supernus for SPN-830, a Potential Treatment for Motor Fluctuations in Parkinson Disease

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Supernus Pharmaceuticals announced that the FDA has sent a Complete Response Letter (CRL) in response to its application for the approval of SPN-830, an investigational apomorphine infusion device designed to continuously treat motor fluctuations in Parkinson disease. According to the FDA, the current application cannot be approved due to two main issues. First, product quality data needs to be reviewed, and second, the FDA required more information from the device manufacturer's master file. Despite the setback, there were no clinical or safety issues reported.¹

“We remain committed to bringing SPN-830 to the market as an important treatment option for PD patients who experience motor fluctuations associated with off episodes. We will work with the FDA to address the CRL and to successfully resubmit our SPN-830 NDA,” said Jack Khattar, president, CEO, Supernus, in a press release.

In October 2022, Supernus received an initial CRL for SPN-830, with the FDA stating that additional information such as labeling, product quality and manufacturing, device performance, and risk analysis were required. Further, there were inspections required at the time that couldn’t be completed as a result of COVID-19 travel restrictions.²

“SPN-830 remains a key priority for Supernus as there is a need to provide a minimally invasive therapy for PD patients who are experiencing motor fluctuations not adequately controlled with current treatment options,” said Khattar, in a 2022 press release. “We are committed to PD patients and to working with the FDA to address the CRL issues so that we can put the NDA back on track towards potential US approval.”

Last October, Supernus resubmitted its New Drug Application (NDA) for SPN-830. As part of the resubmission, the company worked in conjunction with the FDA to address the previously mentioned issues.³

In November, the FDA acknowledged receipt of the resubmission and assigned the NDA with a Prescription Drug User Fee Act goal date of April 5, 2024.⁴

“We are pleased with the FDA’s acceptance of our NDA resubmission for SPN-830 and look forward to continuing to work with them during their review,” said Khattar, in a press release. “SPN-830 is an important product candidate which, if approved by the FDA, represents a novel and less invasive treatment option for PD patients.”

Based on information from the Parkinson’s Foundation, around 90,000 people in the United States are diagnosed with PD each year, and it is expected to affect a total of 1.2 million individuals by 2030. Reportedly, those numbers represent a 50% increase from previous statistics. In its Incidence of Parkinson Disease in North America study, the foundation also found that incidence estimates increase in senior populations, with age being the main risk factor. Further, the disease is more common in males, and rates are higher in regions previously regulated by industrial manufacturing.⁵

“These updated estimates of incidence are necessary for understanding disease risk, planning health care delivery, and addressing care disparities. Knowing this information will allow us to better serve people with Parkinson’s and their families and plan for adequate health care services in the future,” explained James Beck, PhD, chief scientific officer, Parkinson’s Foundation, according to the foundation’s study.

References

1. Supernus Provides Regulatory Update for SPN-830. GlobeNewswire. April 8, 2024. Accessed April 8, 2024. https://www.globenewswire.com/news-release/2024/04/08/2859160/0/en/Supernus-Provides-Regulatory-Update-for-SPN-830.html

2. Supernus Provides Regulatory Update on SPN-830. Supernus. October 10, 2022. Accessed April 8, 2024. https://ir.supernus.com/news-releases/news-release-details/supernus-provides-regulatory-update-spn-830

3. Supernus Resubmits NDA for SPN-830 Apomorphine Infusion Device. Supernus. October 9, 2023. Accessed April 8, 2024. https://ir.supernus.com/news-releases/news-release-details/supernus-resubmits-nda-spn-830-apomorphine-infusion-device-0

4. Supernus Announces SPN-830 Apomorphine Infusion Device NDA Accepted for Review by FDA. Supernus. November 2, 2023. Accessed April 8, 2024. https://ir.supernus.com/news-releases/news-release-details/supernus-announces-spn-830-apomorphine-infusion-device-nda

5. Prevalence & Incidence. Parkinson’s Foundation. Accessed April 8, 2024. https://www.parkinson.org/understanding-parkinsons/statistics/prevalence-incidence#:~:text=Parkinson's%20Incidence,rate%20of%2060%2C000%20diagnoses%20annually.