(Reuters) – The U.S. Food and Drug Administration on Thursday approved a sublingual film from Sunovion Pharmaceuticals Inc, a unit of Japan-based Sumitomo Dainippon Pharma , for the treatment of “off” episodes in patients with Parkinson’s disease, the company said.
Parkinson’s disease is a nervous system disorder in which patients suffer from motor fluctuations which oscillate between “off” times, a state of decreased mobility, and “on” times, or periods when the medication is working and symptoms are controlled. (https://bit.ly/2Xklr2A)
The disease causes patients to experience tremors, impaired balance and difficulties in swallowing and speaking. It affects about 60,000 Americans every year, according to the Parkinson’s Foundation.
Kynmobi is a thin film that diffuses the drug, apomorphine hydrochloride, into the blood through the tissues under the tongue.
Sunovion acquired Kynmobi as part of its 2016 buyout of Canada’s Cynapsus Therapeutics Inc for over $600 million. The company said it expects Kynmobi to be available in U.S. pharmacies by September 2020.
Drug developer Aquestive Therapeutics had entered into a license agreement with Cynapsus Therapeutics in 2016, before Sunovion’s acquisition, and expects to receive royalties from sale of Kynmobi.
(Reporting by Manojna Maddipatla in Bengaluru; Editing by Krishna Chandra Eluri)