Kynmobi to be discontinued in US and Canada due to limited use
Sunovion withdrawing sublingual treatment for off episodes from US by June 30
Kynmobi (apomorphine hydrochloride), an under-the-tongue therapy approved to help manage off episodes in Parkinson’s disease, is being discontinued in the U.S. as of June 30.
Sunovion, which developed the treatment, is voluntarily withdrawing the drug from the U.S. market “due to limited utilization,” according to an announcement on the therapy’s website. Kynmobi is also expected be discontinued in Canada by Sept. 30, according to Drug Shortages Canada.
The announcement comes just a few months after Sunovion closed its patient support program for the therapy, called Kynmobi Kynnect. The program ended at the end of 2022, stated a letter sent to healthcare providers.
Patients who are currently using the therapy are advised to consult with their healthcare providers about finding alternative treatments.
Parkinson’s disease is characterized by the death and dysfunction of cells in the brain that are responsible for producing the signaling molecule dopamine. The resulting lack of dopamine drives many disease symptoms.
Levodopa and its derivatives, which are medications that give the brain more raw material with which to make dopamine, are a standard part of care for Parkinson’s disease. While these medications can be effective for managing Parkinson’s symptoms, many patients experience off episodes, where symptoms are not fully controlled in between doses of levodopa.
Kynmobi’s active ingredient, apomorphine, can mimic dopamine’s effects
Kynmobi’s active ingredient, apomorphine, is able to cross into the brain and mimic the effects of dopamine. By mimicking dopamine in the brain, the therapy can help to ease symptoms during off episodes.
The same active agent is available in an older formulation, marketed as Apokyn by Supernus Pharmaceuticals, which is administered by injection under the skin. Kynmobi was designed to deliver apomorphine via a film placed under the tongue, to make administration easier and more convenient for patients.
The U.S. Food and Drug Administration approved Kynmobi in May 2020 to treat off episodes in Parkinson’s, and Health Canada issued a similar approval about a month later. The approvals were supported by data from a Phase 3 clinical trial (NCT02469090), which showed that Kynmobi outperformed a placebo in easing Parkinson’s symptoms during off episodes. Now, nearly three years after it first entered the U.S. market, Kynmobi will be discontinued.
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