Levadopa inhalation powder for Parkinson’sFebruary 5, 2019
Levodopa inhalation powder (Inbrija) has been granted marketing approval by US FDA for intermittent treatment of OFF episodes in people with Parkinson’s disease, Acorda Therapeutics, Inc announced.
OFF episodes, also known as OFF periods, are defined as the return of Parkinson’s symptoms that result from low levels of dopamine between doses of oral carbidopa/levodopa, the standard oral baseline Parkinson’s treatment.
FDA approval of the inhalable levadopa was based on a clinical programme that included approximately 900 people with Parkinson’s on a carbidopa/levodopa regimen experiencing OFF periods.
The Phase 3 pivotal efficacy trial – SPANSM-PD – was a 12-week, randomized, placebo controlled, double blind study evaluating the effectiveness of INBRIJA in patients with mild to moderate Parkinson’s experiencing OFF periods.
The SPAN-PD trial met its primary endpoint, with patients showing a statistically significant improvement in motor function at the Week 12 visit, as measured by a reduction in Unified Parkinson’s Disease Rating Scale (UPDRS) Part III score for Inbrija 84 mg compared to placebo at 30 minutes post-dose. The onset of action was seen as early as 10 minutes.
The drug was also studied in a Phase 3 long-term, active-controlled, randomized, open-label study assessing safety and tolerability over one year. This study showed the average reduction in FEV1 (forced expiratory volume in 1 second) from baseline was the same for the Inbrija and observational cohorts.
Inbrija is expected to be commercially available by prescription in the U.S. in the first quarter of 2019.