Supernus Wins FDA Approval for Parkinson’s Infusion Pump Onapgo

Three strikes and you’re out? Not for Supernus Pharmaceuticals and its Parkinson’s disease infusion pump.

On its fourth attempt to pass muster with the FDA, the company’s SPN-830, now branded as Onapgo, finally earned the agency’s stamp of approval to treat motor fluctuations in adults with advanced Parkinson’s.

Onapgo is a wearable pump designed to provide a continuous subcutaneous infusion of Supernus’ apomorphine (Apokyn). The drug is meant to allow patients more control over their daily ""off"" time, or the instances when patients' medicine wears off and symptoms return or worsen. 

A continuous treatment like Onapgo can “help to make days with Parkinson’s more predictable,” Andrea Merriam, CEO of the Parkinson & Movement Disorder Alliance, explained in Supernus' press release on Tuesday.

In a phase 3 study, the drug cut down on patients' daily ""off"" time after 12 weeks of treatment while also providing a significant increase in daily ""good on"" time, periods when medication works as intended and patients don't experience involuntary movements.

Onapgo represents a “novel approach” for those with Parkinson’s motor fluctuations and showcases the company’s “continued commitment to developing novel alternatives to manage Parkinson’s disease and other neurological conditions,” CEO Jack Khattar said in the company's press release.

Supernus is already gearing up for a launch and intends to make the drug available in the second quarter of this year. 

Related
FDA swats away Supernus' Parkinson's disease infusion pump for 3rd time
It’s been nearly a five-year journey to this point for Supernus after the company acquired the device and Apokyn from US WorldMeds in 2020. After quickly filing for approval, the FDA responded with a refuse-to-file notice, meaning that the agency didn’t have enough information to perform a thorough review.

Then, in 2022, the FDA shut down the company’s second approval bid with a complete response letter requesting more information on the drug's labeling, manufacturing and other factors, Supernus disclosed at the time.

Most recently, the agency again issued a complete response letter upon Supernus’ third approval try. In its rejection letter last year, the agency cited issues with product quality and the drug’s master file.

Related
2 years after FDA refusal, infusion device issues sink Supernus' Parkinson's filing
While the fourth time proved the charm for Supernus, it took AbbVie and its continuous subcutaneous Parkinson’s pump three tries to finally cross the FDA finish line in October. That treatment, Vyalev, is made up of prodrugs of standard-of-care medicines carbidopa and levodopa. 

Supernus’ Apokyn contributed $19.9 million to the company’s total sales over the third quarter of 2024. In 2023, the drug pulled in $75.1 million in full-year sales.

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