FDA Gives Thumbs-Up to Sunovion's Under-the-Tongue Parkinson's Drug

Parkinson's

Sunovion Pharmaceuticals, based in Marlborough, Massachusetts, announced the U.S. Food and Drug Administration (FDA) had approved Kynmobi (apomorphine HCl) sublingual film for Parkinson’s disease.

Specifically, Kynmobi was approved for the acute, intermittent treatment of OFF episodes in Parkinson’s patients. Parkinson’s disease is a chronic neurodegenerative disorder where the cells that produce dopamine are lost. OFF episodes are when Parkinson’s symptoms get worse or re-emerge when they were otherwise controlled by oral levodopa/carbidopa. Those symptoms include tremor, stiffness, slow movements.

Kynmobi dissolves under the tongue and is indicated to improve patients’ OFF symptoms as needed.

“Today’s approval of Kynmobi advances treatment options for people with Parkinson’s disease who experience OFF episodes and the associated disruption of everyday activities,” said Antony Loebel, Sunovion’s president and chief executive officer. “We are pleased to offer the Parkinson’s disease community a novel treatment option that we believe offers a convenient way for patients to rapidly improve impaired movements and better control their motor symptoms when they need it.”

Kynmobi is the first FDA-approved sublingual formulation apomorphine. Apomorphine is approved by the FDA for the acute, intermittent treatment of OFF episodes as a subcutaneous injection.

The agency originally issued a Complete Response Letter in January 2019. The first New Drug Application was submitted in March 2018, but the FDA reported it could not approve the application in the submitted form, requesting additional information and analyses. No new clinical trials were required.

Sunovion licensed apomorphine sublingual film from Aquestive Therapeutics, based in Warren, New Jersey.

The approval was built in data from a Phase III trial that enrolled 109 patients. The results were published in The Lancet, showing that patients receiving the drug demonstrated an average decrease of 7.6 points on the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III score. The response to the sublingual film was also fast, with early improvement seen 15 minutes after placing the film under the tongue. The drug was well tolerated, with the most common side effects being nausea, throat reactions, drowsiness and dizziness. However, the throat problems caused about 17% of patients to drop out of the study—although, interesting, one patient in the placebo group dropped out as well.

There is a warning on the label against patients taking the drug if they are already prescribed a class of drugs known as 5HT3 antagonists for nausea. In combination with apomorphine, they can cause low blood pressure and unconsciousness.

Other products on the market Sunovion will compete with include Acorda Pharmaceuticals’ Inbrija, an inhaled formulation of levodopa, US WorldMeds’ Apokyn, an apomorphine injection pen, and Xadago (safinamide) tablets.

“Several years after a person is diagnosed with Parkinson’s disease they may notice problems such as having trouble getting out of bed in the morning or having difficulty getting out of a chair, or that they feel frozen while trying to walk as the effect of their maintenance medication diminishes,” said Stewart Factor, professor of Neurology, director of the Movement Disorders Program and Vance Lanier Chair of Neurology at Emory University School of Medicine. “The approval of Kynmobi affords health care providers with a needed option that can be added to their patients’ medication regimen to adequately address OFF episodes as their Parkinson’s disease progresses.”

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