Levodopa inhalation powder (Inbrija) bagged U.S Food and Drug Administration approval for intermittent treatment of “off” episodes in people with Parkinson’s disease who are already taking an oral carbidopa-levodopa regimen, announced Acorda Therapeutics.
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.
“This milestone resulted from over two decades of research and development, through years of enormous perseverance and ingenuity by the entire Acorda team,” said Ron Cohen, M.D., Acorda President and CEO.
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. 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.
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 (-9.83 points and -5.91 points respectively). The 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 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 (-0.1 L) for the Inbrija and observational cohorts. Patients with chronic obstructive pulmonary disease (COPD), asthma, or another chronic respiratory disease within the last five years were excluded from this study.
As people with asthma may take a puff from an inhaler when they have trouble breathing, similarly, some with Parkinson’s may soon be able to take a breath of levodopa when they have trouble moving.
Parkinson’s disease (PD) is a neurodegenerative disorder characterized by three principal motor features – resting tremor, rigidity, and bradykinesia – though others may exist.