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FDA rejects Supernus’ drug infusion device for Parkinson’s

The agency issued a complete response letter to Supernus for its device to treat “off” episodes in Parkinson’s.

The Food and Drug Administration has rejected Supernus Pharmaceuticals’ drug infusion device for Parkinson’s disease, the company revealed on Monday.

Supernus said the agency issued a complete response letter to its application for approval. Dubbed SPN-830, the treatment is a device designed to continuously deliver the drug apomorphine under the skin for “off” episodes in Parkinson’s patients. This common side effect occurs when the effects of other drugs used to control Parkinson’s-related tremors and other motor symptoms wear off.

Apomorphine, the active drug contained in Supernus’ device, was approved by the FDA in 2004 as an injection sold under the brand name Apokyn. In 2020, Sunovion Pharmaceuticals won approval for an under-the-tongue film formulation of apomorphine to treat “off” episodes.

Other drug developers have been doing something similar, attempting to reformulate existing Parkinson’s drugs to either make them more convenient or more consistently effective. Acorda Therapeutics’ drug Inbrija, for example, is an inhaled formulation of levodopa, a mainstay Parkinson’s therapy. AbbVie, meanwhile, is asking the FDA for approval of a treatment that combines prodrug forms of levodopa and carbidopa.

Along with Acorda’s and Sunovion’s drugs, medicines from Kyowa Kirin and Neurocrine Biosciences have also won approval for the treatment of “off” episodes. Not all have sold well since their approval, however. The FDA cited several reasons in its rejection of SPN-830, according to Supernus. The regulator flagged issues with labeling and device performance, as well as its inability to inspect a manufacturing facility on time due to COVID-19 travel restrictions — a hangup that’s been seen in other drug reviews.

The rejection is “a disappointing but not major setback from long-term revenue perspective,” wrote Stifel analyst Annabel Samimy in a Monday note to clients. Samimy noted that the FDA is not asking for additional clinical studies to test its device. Supernus said it will work with the agency to address the issues and put its new drug application back in front of reviewers.

Shares in Supernus fell by 3% in Monday morning trading on the news.

Delilah Alvarado, Associate Editor

Published Oct. 10, 2022

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