FDA to decide on SPN-830 apomorphine pump approval Feb. 1
Developer says agency acknowledged NDA submission, set date
The U.S. Food and Drug Administration (FDA) has set Feb. 1, 2025, as a goal date for deciding whether to approve SPN-830, an apomorphine infusion pump, for the continuous treatment of off episodes in Parkinson’s disease.
That’s according to a financial update from the device’s developer, Supernus Pharmaceuticals, which submitted, for the fourth time, a new drug application seeking SPN-830’s approval.
Parkinson’s is a chronic neurological condition characterized by the gradual loss of brain cells that produce dopamine, a brain chemical that helps control movement.
Standard treatments, like levodopa, provide temporary dopamine increases to ease symptoms. However, over time patients may experience reduced effectiveness between doses, leading to periods of symptom re-emergence that are known as off episodes.
Apomorphine is a molecule that mimics the action of dopamine in the brain. Apokyn, Supernus’ apomorphine-based medication that’s delivered through under-the-skin, or subcutaneous, injections, is approved to reduce Parkinson’s off periods on demand.
Trials show sustained benefits
SPN-830 is a portable electronic pump, typically placed on the abdomen or upper thigh, that continuously delivers apomorphine subcutaneously over more than 10 hours. This is meant to keep apomorphine levels steady, potentially reducing the frequency of off episodes and making symptom control more consistent.
Two Phase 3 trials, TOLEDO (NCT02006121) in Europe and INFUS-ON (NCT02339064) in the U.S., tested the therapy in people with advanced Parkinson’s who were experiencing several hours of daily off time despite available therapies.
TOLEDO data showed that SPN-830 was significantly superior to a placebo continuous infusion at reducing daily off time, with benefits sustained for more than one year. INFUS-ON results also demonstrated that SPN-830 decreased daily off time.
Supernus, which acquired the rights to Apokyn and the SPN-830 pump from US WorldMeds in 2020, has encountered several challenges on the path to SPN-830’s potential approval.
The FDA said that the first application, filed in 2020, lacked sufficient data for review and requested more supporting data. The company resubmitted its application at the end of 2021, to which the agency responded with concerns regarding SPN-830’s labeling, performance, risk analysis, and manufacturing. No concerns in terms of the therapy’s safety and efficacy were cited.
A new application, which Supernus said addressed all of those concerns, was accepted by the FDA in November 2023, with an expected decision by April 5. But earlier this year the agency requested more information on the product’s quality and the infusion device’s master file, which is proprietary to the device manufacturer.
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