FDA sets date in 2024 for decision on SPN-830 apomorphine pump

Agency agrees to review Supernus' device for approval for Parkinson's

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by Steve Bryson, PhD |

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The U.S. Food and Drug Administration (FDA) has accepted Supernus Pharmaceuticals‘ new application seeking approval of its apomorphine infusion pump — known as SPN-830 — to treat motor fluctuations in people with Parkinson’s disease.

A decision on the company’s request, resubmitted last month in the form of a new drug application (NDA), is expected by April 5, 2024.

“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,” Jack Khattar, Supernus’ president and CEO, said in a company press release.

In submitting the new application, Supernus had stated that all previous concerns raised by the FDA — on manufacturing and other non-efficacy issues — had been addressed.

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Parkinson’s disease is caused by the dysfunction and death of cells in the brain that make the signaling molecule dopamine. The resulting dopamine deficiency leads to the onset of Parkinson’s symptoms, affecting both motor and nonmotor skills.

Levodopa and derivatives are the standard Parkinson’s treatment and provide patients with the materials to make dopamine. However, the long-term use of these medications is associated with so-called off periods, when therapeutic effects wear off and symptoms re-emerge between scheduled doses.

Supernus’ approved therapy Apokyn (apomorphine hydrochloride injection) is a subcutaneous or under-the-skin injection of apomorphine, a small molecule that mimics the action of dopamine in the brain, and is intended to reduce off periods on demand.

SPN-830 is a subcutaneous formulation of apomorphine that is delivered continuously through an infusion pump. Such administration has the potential to be less invasive, with fewer injection sites, and more convenient than Apokyn.

SPN-830 is an important product candidate which, if approved by the FDA, represents a novel and less invasive treatment option for [Parkinson’s] patients.

According to Khattar, “SPN-830 is an important product candidate which, if approved by the FDA, represents a novel and less invasive treatment option for [Parkinson’s] patients.”

Supernus acquired the rights to Apokyn and the SPN-830 pump from US WorldMeds in 2020 and, a few months later, asked the FDA to approve the device for Parkinson’s. However, the agency said the application was missing certain data needed to complete the review.

Following a meeting with the FDA to clarify the requirements for refiling, the company resubmitted its application at the end of 2021.

However, the agency last year again requested additional information — with a focus on the therapy’s labeling, performance, risk analysis, and manufacturing. On manufacturing, the COVID-19 pandemic had prevented the completion of required facility inspections.

Importantly, no new clinical safety and efficacy data were requested.

Supernus’ regulatory application was based mostly on results from two Phase 3 clinical trials: TOLEDO (NCT02006121) in Europe and INFUS-ON (NCT02339064) in the U.S.

TOLEDO involved 107 Parkinson’s patients who had at least three hours of daily off time while on an optimized dopamine-replacing therapy. Three months of treatment with SPN-830 was found to be superior to a placebo continuous infusion at reducing off time, with benefits sustained through the trial’s 1-year extension phase.

In INFUS-ON, all 99 Parkinson’s patients in the trial received the experimental therapy for about a year. After about three months on SPN-830, patients’ daily off time was seen to decrease by about three hours from an average of six hours per day.

The therapy was generally well-tolerated, with the most common side effects including nodules or redness at the infusion site, nausea, dyskinesia or involuntary movements, and sleepiness.