Kynmobi is the first sublingual therapy approved for the on-demand treatment of Parkinson’s disease OFF episodes.
Besides Kynmobi, Apomorphine is also available as subcutaneous injection dosage form (Apokyn).
As mentioned in Sunovion’s press release, “OFF episodes are the re-emergence or worsening of PD symptoms otherwise controlled with oral levodopa/carbidopa. They may be characterized, in part, by tremor, stiffness, slowed movement or other symptoms. These disruptive episodes can occur in the morning upon waking and throughout the day. KYNMOBI dissolves under the tongue to help people with PD improve their OFF symptoms as needed.”
Approval date: 21 May 2020
Innovator: Sunovion
Route and Dosage form: Sublingual film
Strengths: 10 mg, 15 mg, 20 mg, 25 mg and 30 mg
Indication: for the acute, intermittent treatment of “off” episodes in patients with Parkinson’s disease.
Excipients employed in Kynmobi:
Polymers: hydroxyethyl cellulose, hypromellose
Plasticizer: glycerol
Permeation enhancer: glyceryl monostearate
pH neutralizing agents: pyridoxine hydrochloride, sodium hydroxide
Antioxidants: sodium metabisulfite, disodium EDTA, dehydrate
Flavoring agent: (-)-Menthol
Sweetening agent: sucralose
Other Excipients: maltodextrin, FD&C Blue #1, and white ink
Launch plan: As mentioned in Sunovion’s press release, Sunovion expects KYNMOBI to be available in U.S. pharmacies in September 2020.
Prescribing information: See here
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