FDA says it needs more info on SPN-830 before decision on device
Supernus had sought approval of apomorphine infusion pump for 3rd time
The U.S. Food and Drug Administration (FDA) said it needs more information before deciding whether to approve the apomorphine infusion pump SPN-830 for the treatment of Parkinson’s disease, according to a press release from the device’s developer Supernus Pharmaceuticals.
In a complete response letter (CRL) to Supernus‘ third application for approval of the device, the FDA indicated that the review cycle for the application is complete, but that “the application is not ready for approval in its present form,” the company stated.
The FDA’s response letter specifically mentioned two main concerns: one regarding the quality of the product, and the other related to the master file for the infusion device, which is proprietary to the device manufacturer.
Regarding the first issue, the company noted that it recently submitted more data to the FDA, which has not yet been reviewed. Concerning the second issue, Supernus plans to talk to the device manufacturer about providing the necessary information and taking any needed steps to resubmit its new drug application (NDA) for SPN-830.
No clinical safety or effectiveness concerns were cited as a requirement for approval, according to the company. Further, Supernus noted that the FDA had successfully conducted a preapproval inspection of the device manufacturer’s facility in February 2024.
“We remain committed to bringing SPN-830 to the market as an important treatment option for PD [Parkinson’s disease] 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 and CEO of Supernus.
SPN-830 found to reduce daily off time in over 60% of patients in trial
Parkinson’s is caused by the death and dysfunction of brain cells responsible for making the chemical messenger dopamine, low levels of which drive most disease symptoms.
The gold standard treatment for Parkinson’s is levodopa, which works to give brain cells more materials to make dopamine. While levodopa can be highly effective for easing Parkinson’s symptoms, patients often have off periods in which symptoms aren’t well controlled between scheduled levodopa doses.
Apomorphine is a small molecule designed to ease Parkinson’s symptoms by mimicking dopamine’s activity in the brain. It’s approved as Apokyn, among others, to treat off periods in Parkinson’s.
Apokyn and other approved formulations are given by routine injections under the skin, known as subcutaneous injections. SPN-830, meanwhile, is a pump that subcutaneously delivers the therapy continuously over 14 to 18 hours to allow steadier levels of the medication and, in turn, provide more consistent symptom control. The infusion pump typically is placed on the abdomen or upper thigh.
A Phase 3 trial called INFUS-ON (NCT02339064), sponsored by SPN-830’s former developer US WorldMeds, tested the device in people with Parkinson’s who were having several hours of daily off time despite available therapies. The results showed that SPN-830 treatment reduced daily off time by at least two hours a day in more than 60% of patients.
SPN-830 also increased so-called good on time — that is, when symptoms are adequately managed without troublesome dyskinesia, or uncontrolled movements.
The pump was generally well tolerated, though nonsevere skin reactions like redness at the infusion site were common.
An earlier Phase 3 clinical trial, dubbed TOLEDO (NCT02006121), also had suggested that SPN-830 could reduce off time and increase good on time.
Supernus secured the rights to the SPN-830 pump from US WorldMeds in 2020. As part of the deal, Supernus also acquired the rights to Apokyn.
The company has struggled to bring the pump to market in the U.S. since asking the FDA to approve SPN-830 soon after acquiring it nearly four years ago.
The agency said the first application lacked data for review. Supernus resubmitted its application at the end of 2021, but the FDA again said more information was needed. Among other issues, the agency noted it was unable to conduct certain facility inspections due to travel restrictions as a result of the COVID-19 pandemic.
Supernus applied to the FDA for a third time last October, saying the this application addressed all concerns previously raised by regulators. The application was accepted for review a month later, with action expected by April 5 of this year.
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