Acorda submits NDA for Inbrija in PD

Acorda Therapeutics Inc. (NASDAQ: ACOR) submitted an NDA to FDA for Inbrija levodopa inhalation powder (CVT-301) to treat "off" periods in patients with Parkinson's disease (PD) taking a carbidopa/levodopa regimen.

Inbrija is an inhaled formulation of levodopa delivered via Acorda's Arcus inhalation technology. The company submitted the NDA under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products...