Sunovion Pharmaceuticals announced that the FDA approved Kynmobi (apomorphine) for the acute, intermittent treatment of OFF episodes in patients with Parkinson's disease. The company noted that the product, which is expected to be available in September, is the first and only sublingual film authorised in this indication.
"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," remarked CEO Antony Loebel. Sunovion indicated that Kynmobi dissolves under the tongue to help people with Parkinson's disease improve their OFF symptoms as needed and can be used up to five times a day.
In January last year, the FDA issued  a complete response letter regarding Sunovion's marketing application for Kynmobi, previously known as APL-130277, with the agency requesting additional information and analyses, but no new clinical studies. The company, which is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma, resubmitted  the filing in November, with the application including information about intended packaging, as well as additional analyses of clinical data.
In the Phase III CTH-300 study, results  showed that patients with Parkinson's disease receiving Kynmobi experienced significant improvements in motor symptoms at 30 minutes after dosing at week 12, with a mean reduction of 7.6 points, compared to placebo, on the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score. In addition, a significantly higher percentage of people treated with the dopamine agonist had a patient-rated full ON response within 30 minutes at week 12, compared with placebo.