Acorda Therapeutics announced that the Food and Drug Administration (FDA) has approved Inbrija (levodopa inhalation powder) for intermittent treatment of OFF episodes in patients with Parkinson’s disease treated with carbidopa/levodopa. This is the first and only inhaled levodopa to be approved by the FDA for this condition.
Inbrija is a novel form of levodopa, the metabolic precursor of dopamine. It utilizes the ARUS technology platform that allows systemic delivery of medication through inhalation by turning molecules into a light, porous dry powder. Through this, substantially higher doses of medication can be delivered via conventional dry powder technologies.
The approval was supported by data from a clinical program enrolling approximately 900 people with Parkinson’s disease on a carbidopa/levodopa regimen experiencing OFF episodes. One 12-week, randomized, placebo-controlled, double-blind phase 3 study, SPAN-PD (N=226), evaluated the efficacy of Inbrija in patients with mild to moderate Parkinson’s disease experiencing OFF periods. Treatment with Inbrija led to a statistically significant improvement in motor function at the week 12 visit as evident by a reduction in Unified Parkinson’s Disease Rating Scale (UPDRS) part III score for Inbrija 84mg vs placebo at 30 minutes post-dose (-9.83 points vs -5.91 points; P =.009). The onset of action was seen as soon as 10 minutes.
Another phase 3 long-term, active-controlled, randomized, open-label study (N=398) evaluated the safety and tolerability of Inbrija over 1 year. Lung function was assessed by spirometry every 3 months in both groups. The average reduction in FEV1 from baseline was the same (-0.1L) for both the Inbrija and observational cohorts after 12 months.
Cough, upper respiratory tract infection, nausea, and discolored sputum were the most common adverse reactions seen with Inbrija in the clinical trial.
Inbrija will be available as a carton containing sixty 42mg capsules and one inhaler, which is breath-actuated by the patient. The product is anticipated to launch in the first quarter of 2019; it will be distributed through a network of specialty pharmacies.
For more information call (800) 367-5109 or visit Inbrija.com.