Sunovion files for FDA approval of apomorphine sublingual film for Parkinson's disease OFF episodes

Sunovion Pharmaceuticals announced Friday that it has submitted an application to the FDA seeking marketing approval for a sublingual film formulation of apomorphine to treat motor fluctuations, or OFF episodes, associated with Parkinson's disease. The company noted that its filing for apomorphine sublingual film, also known as APL-130277, is supported by data from the Phase III CTH-300 trial, which met its primary and key secondary endpoint.

The randomised study involved patients with levodopa-responsive Parkinson's disease complicated by OFF episodes. Sunovion unveiled top-line results in January from 109 patients, showing that patients with OFF episodes who received apomorphine sublingual film achieved a significant mean reduction in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score at week 12, compared with placebo. Specifically, the difference in MDS-UPDRS Part III score change from baseline to 30 minutes post-dose between the apomorphine and placebo groups was 7.6, "with effects persisting until the last observed time point at 90 minutes," the company said.

In regards to the key secondary endpoint, Sunovion indicated that at the 12-week mark, 35 percent of patients treated with apomorphine sublingual film had a patient-rated full ON response within 30 minutes after dosing, compared to 16 percent for placebo. The drugmaker, which noted that apomorphine sublingual film was also generally well-tolerated among participants, said study results would be presented at a future scientific meeting.

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According to Sunovion, its formulation of apomorphine, a dopamine agonist, "is being developed as a fast-acting medicine for the on-demand treatment of all types of motor OFF episodes, including morning OFF, unpredictable OFF and end-of-dose wearing OFF." The company pointed out that there are limited on-demand treatment options available for motor OFF episodes, which it estimates are experienced by 40 percent to 60 percent of patients with Parkinson's disease.

Meanwhile, Acorda Therapeutics said in February that the FDA accepted its marketing application for Inbrija, a self-administered, inhaled powder formulation of levodopa for the treatment of OFF-period symptoms in patients with Parkinson's disease who are on a carbidopa/levodopa regimen. The US regulator, which last year had issued a refuse-to-file letter for Acorda's application seeking additional information about Inbrija, is expected to render a decision by October 5.

For related analysis, see ViewPoints: Is a likely approval for Inbrija sufficient to stave off an Acorda buyout? 

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