Some eight months into the launch of Onapgo, the Parkinson’s disease infusion pump Supernus Pharmaceuticals spent years fighting to get across the FDA finish line, the drugmaker is discovering that patients’ appetite for the wearable is more than it can currently handle.
Thanks to “stronger than expected demand for Onapgo,” constraints on suppliers are crimping Supernus’ ability to “fully meet this demand,” the company said in a Nov. 4 earnings release.
“As a result of this supply imbalance, the company is prioritizing care for patients currently on Onapgo,” Supernus explained. “This requires pausing delivery to patients who have not started Onapgo.”
While that pause on new patient starts is in effect, Supernus says it will build out “adequate inventory” of the product and resume full prescribing of Onapgo “as soon as possible.”
It took four attempts for Supernus to finally win FDA approval for Onapgo, which was cleared to treat motor fluctuations in adults with advanced Parkinson’s back in early February.
The product is a wearable pump that delivers a subcutaneous infusion of the company’s apomorphine, designed to allow patients more control over their daily “off” time, or the periods when medication wears off and Parkinson’s symptoms resurface or get worse.
Supernus initially acquired the device and apomorphine, also known by the commercial moniker Apokyn, from US WorldMeds in 2020 and quickly filed for approval, but the FDA rebuffed the effort with a refuse-to-file notice.
The regulator then issued complete response letters to Supernus in 2022 and 2024, at various times citing problems with Onapgo’s labeling, manufacturing and product quality, among other concerns.
After finally securing a green light earlier this year, Supernus launched Onapgo in April and had amassed more than 1,300 enrollment forms from over 450 prescribers as of Sept. 30, according to the company’s press release.
The third quarter marked the product's first full earnings period on the market, and, during that stretch, Onapgo delivered sales of $6.8 million, Supernus said this week. That performance marked an “encouraging start” to the drug’s launch, the company’s CEO, Jack Khattar, said in a statement.
All told, Supernus’ third-quarter revenues clocked in at $192.1 million, representing a 9% increase over the sum the company generated for the same period in 2024. For all of 2025, Supernus now expects to generate revenue between $685 million and $705 million. Previously, the company was aiming for a range between $670 million and $700 million.