FDA approved Inbrija in parkinson's disease.- Acorda Therapeutics.

Acorda Therapeutics announced that the FDA approved Inbrija (levodopa inhalation powder) for intermittent treatment of OFF episodes in people with Parkinson�s disease treated with carbidopa/levodopa. FDA approval of Inbrija was based on a clinical program that included approximately 900 people with Parkinson�s on a carbidopa/levodopa regimen 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 (n=114) compared to placebo (n=112) at 30 minutes post-dose (-9.83 points and -5.91 points respectively; p=0.009). Onset of action was seen as early as 10 minutes. The most common adverse reactions with Inbrija (at least 5% and greater than placebo) in the pivotal trial were cough (15% vs. 2%), upper respiratory tract infection (6% vs. 3%), nausea (5% vs. 3%) and sputum discolored (5% vs. 0%).

Inbrija is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks. 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.