Sunovion Pharmaceuticals Inc.’s apomorphine sublingual film (APL-130277), a dopamine agonist the company will market as Kynmobi, has won FDA approval for the acute intermittent treatment of motor fluctuations (off episodes) associated with Parkinson’s disease (PD).
Sunovion expects Kynmobi to be available in U.S. pharmacies in September. Though declining to disclose pricing before then, it said the drug will be competitively priced with other medications for the treatment of PD off episodes.
Although the FDA granted it fast track status in August 2016, the regulatory process has been anything but fast. Marlborough, Mass.-based Sunovion, a subsidiary of Sumitomo Dainippon Pharma Co. Ltd., received a complete response letter in January 2019 from the FDA asking for no new clinical studies but additional information and analyses. The new drug application was resubmitted in November 2019. Sumitomo acquired Sunovion (then Sepracor Inc.) in 2009 for about $2.6 billion.
Apomorphine is approved as a subcutaneous injection in the U.S. for on-demand, intermittent treatment of off episodes in advanced PD patients. Off episodes are the times when symptoms return due to low dopamine levels between doses of oral carbidopa/levodopa. They are experienced by 40% to 60% of PD patients and there are limited treatment options. A sublingual formulation is a new option that could be used first thing in the morning and up to five times throughout the day.
The drug was approved for dosing at 10 mg to 30 mg per dose and is contraindicated for use with 5HT3 antagonists. Because of the high incidence of nausea and vomiting with Kynmobi when administered at recommended doses, an antiemetic, beginning three days prior to the initial dose of the new medicine is recommended on its label.
Acorda Therapeutics Inc., of Ardsley, N.Y., launched its off-episode PD drug Inbrija (levodopa inhalation powder) in the first quarter of 2019, following a December 2018 approval, but the therapy also stalled when regulators delivered a refusal to file letter in August 2017. Another player, Emeryville, Calif.-based Adamas Pharmaceuticals Inc., markets Gocovri (amantadine) extended-release capsules, which received approval in August 2017 for dyskinesia in PD.
Sunovion gained APL-130277 following its $635 million purchase of Toronto-based Cynapsus Therapeutics Inc. in October 2016. It licensed the film technology from Warren, N.J.-based Aquestive Therapeutics Inc., which said Thursday that it would advance a strategy to monetize anticipated royalties associated with Kynmobi. Keith Kendall, Aquestive’s president and CEO said he expects the company will receive between $50 to $100 million from the monetization, in one or a series of transactions.
Pivotal phase III results emerged in January 2018, with the drug hitting its primary endpoint with a statistically significant mean reduction in off episodes using a common assessment of motor function in PD patients. It also met a key secondary endpoint, showing that a statistically significant greater percentage of people treated with the drug had a patient-rated full “on” response vs. placebo patients.
Sunovion withdrew its NDAs for dasotraline to treat binge-eating disorder (BED) and attention deficit hyperactivity disorder (ADHD) on May 13, just before the company’s PDUFA date for BED, due to the need for additional clinical studies on its benefit-risk profile. The company decided to shelve the product.