The approval enables to use of Kynmobi sublingual film for the acute and intermittent treatment of off episodes in patients with Parkinson’s disease.
Kynmobi, a novel formulation of dopamine agonist apomorphine, is claimed to be the first and only sublingual therapy to treat off episodes linked with Parkinson’s disease.
Parkinson’s disease is a chronic neurodegenerative disease, which is expected to affect 1.2 million Americans by 2030.
The off episodes are said to be the re-emergence or worsening of PD symptoms, which occur in the morning upon waking and across the day.
Kynmobi has the capacity to dissolve under the tongue to help people with PD reduce their off symptoms.
According to the company, the phase 3 clinical study results showed that patients with PD securing Kynmobi showed significant improvements in motor symptoms at 30 minutes after dosing at week 12, with a mean reduction of 7.6 points, compared to placebo.
Sunovion is planning to make Kynmobi available to the pharmacies in the US by the end of September.
Sunovion president and CEO Dr Antony Loebel said: “Today’s approval of KYNMOBI advances treatment options for people with Parkinson’s disease who experience OFF episodes and the associated disruption of everyday activities.
“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.”
In May 2019, Sunovion and PsychoGenics have secured the breakthrough therapy designation from the FDA for their jointly owned psychotropic agent SEP-363856 for the treatment of schizophrenia.
SEP-363856 was discovered by Sunovion in collaboration with PsychoGenics using the in vivo phenotypic SmartCube platform and the artificial intelligence algorithms associated with it.