FDA Seeking Information Before OK of Apomorphine Infusion Device
Agency seeks material on therapy's labeling, performance, risk analysis, manufacturing
The U.S. Food and Drug Administration (FDA) wants more information before it will approve Supernus Pharmaceuticals’ new drug application (NDA) resubmission of SPN-830, its apomorphine infusion pump.
Supernus is seeking the approval of SPN-830 for the continuous treatment of “off” episodes in adults with Parkinson’s disease. These are periods marked by the return of motor symptoms due to levodopa, a common dopamine-replacing medication, wearing off.
A feature of Parkinson’s disease is the loss of neurons, or nerve cells, that produce the neurotransmitter dopamine, a chemical messenger essential for muscle control.
SPN-830 uses an infusion device to continuously deliver apomorphine (sold under the brand name Apokyn, among others) that mimics the action of dopamine in the brain to treat off episodes.
Apomorphine is administered as a subcutaneous (under-the-skin) injection. Using a pump to administer the medicine would mean fewer injection sites, making it more convenient, according to Supernus.
“SPN-830 remains a key priority for Supernus as there is a need to provide a minimally invasive therapy for [Parkinson’s disease] patients who are experiencing motor fluctuations not adequately controlled with current treatment options,” Jack Khattar, president and CEO of Supernus, said in a press release.
Initially sought in December 2020, the company resubmitted its NDA in December 2021 following the FDA’s request for further information and more supporting data. The NDA was granted a standard review and a decision had been expected in early October, according to the announced Prescription Drug User Fee Act (PDUFA) action date.
Now the FDA is asking for additional information regarding several sections of the NDA, including the investigational therapy’s labeling, quality and manufacturing, device performance, and risk analysis. No additional safety and effectiveness clinical studies are required.
Supernus said it is working with the FDA to address its questions. The FDA has set a six-month review period after the company resubmits its amended NDA.
Travel restrictions because of the COVID-19 pandemic also prevented the FDA from completing all the inspections necessary for approval, according to the press release.
“We are committed to [Parkinson’s disease] patients and to working with the FDA to address the [complete response letter] issues so that we can put the NDA back on track towards potential U.S. approval,” Khattar said.
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