Supernus Submits SPN-830 Apomorphine Infusion Pump for FDA Approval

Supernus Pharmaceuticals has submitted a new drug application to the U.S. Food and Drug Administration (FDA) seeking approval of SPN-830, its apomorphine infusion pump, the company said.

If approved, the pump will be used for the continuous treatment of on-off episodes in adults with Parkinson’s disease who continue to experience motor symptoms after treatment with oral levodopa and at least one other noninvasive Parkinson’s therapy.

Parkinson’s is characterized by low levels of the neurotransmitter dopamine, a chemical messenger in the brain. Dopamine-replacing therapies such as levodopa can effectively control motor symptoms; however, these therapies usually grow less effective over time, resulting in off periods — times in which symptoms persist in spite of treatment.

Apomorphine (brand name Apokyn) is a treatment for off periods that works by mimicking the activity of dopamine in the brain. While the medication does not prevent off episodes, it can lessen symptoms once episodes have begun. It is given by subcutaneous or under-the-skin injection.

Supernus acquired rights to the medication, as well as the SPN-830 pump, from US WorldMeds earlier this year. The pump is designed to allow for the continuous delivery of injections, aiming to give patients a way to administer the medication that is less invasive and more convenient for them.

“We believe the continuous treatment of “OFF” episodes may offer PD [Parkinson’s] patients an important alternative over currently available acute treatments,” Jack Khattar, president and CEO of Supernus, said in a press release.

“Current alternatives to acute treatment often require continuous infusion of levodopa through a gastric tube or surgical intervention such as deep brain stimulation. SPN-830, if approved by the FDA, would offer patients a less invasive and a convenient option in the form of a continuous subcutaneous infusion of apomorphine,” Khattar said.

Supernus’ application to the FDA is supported by a data package that includes findings from the Phase 3 clinical trials TOLEDO (NCT02006121) and INFUS-ON (NCT02339064). Both trials involved people with Parkinson’s who were experiencing substantial off periods — at least three hours each day, on average — with optimized treatment. Cumulatively, the trials enrolled more than 200 participants.

Both trials used similar dosing schedules and followed participants for 12 weeks (about three months).

TOLEDO was a placebo-controlled trial, which means that some participants were treated with SPN-830 while others were given an inactive placebo. Treatment with SPN-830 reduced patients’ average daily off time by significantly more than did the placebo (2.47 vs. 0.58 hours/day).

Conversely, INFUS-ON was an open-label trial, meaning all participants were given active treatment. Relative to the start of the study, the average daily time spent in off periods decreased significantly — by three hours per day — after 12 weeks of treatment with SPN-830.

Safety data in both studies were generally positive, with most reported adverse events mild or moderate in severity. The most common adverse events associated with SPN-830 included injection site reactions, nausea, and uncontrolled muscle movements, called dyskinesia.