Acorda Therapeutics announced that CVT-301 (levodopa inhalation powder), an agent in development for the treatment of “off” period symptoms in Parkinson’s disease (PD), has demonstrated statistical significance in its Phase 3 SPAN-PD trial. The data was presented at the International Congress of Parkinson’s Disease and Movement Disorders (MDS) in Vancouver, BC.

An off period in PD is defined as the re-emergence of PD symptoms, such as impaired movement and tremors, despite adequately optimized treatment regimens. Off periods may decrease the quality of life of patients, and may become more frequent and severe as the disease progresses.

The SPAN-PD trial, a 12-week, placebo-controlled study (n=339), evaluated the use of CVT-301 in achieving meaningful improvement in motor function as defined by the Unified Parkinson’s Disease Rating Scale—Part III (UPDRS III), the study’s primary endpoint. The study considered secondary endpoints such as the achievement of an “on” state maintenance, during which PD symptoms are well-controlled, and Patient Global Impression of Change (PGIC).

Participants received CVT-301 60mg, CVT-301 84mg or placebo by inhalation. By the conclusion of the trial, the 84mg group demonstrated significant improvement in UPDRS III vs. placebo (–9.83 vs. –5.91, P=0.009). The authors also compared the percentage of patients off to on and remaining on at 60 minutes post-dose; the 84mg group was superior to placebo (P=0.003). On a nominal basis, CVT-301 84mg proved superior in terms of achieving improvement on PGIC (P<0.001) vs. placebo. 

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Additionally, Acorda presented data from its long-term safety study, which compared CVT-301 84mg with an observational control group in a 52-week open-label study. The safety study assessed mean changes in pulmonary function via measurements of forced expiratory volume in 1 second (FEV1) and diffusing capacity of the lung for carbon monoxide (DLco). The study concluded that there was no statistical difference in either FEV1 or DLco between the randomized arms.

The most common adverse events reported in the SPAN-PD trial included cough, upper respiratory tract infection, nausea, sputum discoloration and dyskinesia. The long-term safety study produced similar results, with the most common events being mild cough, nasopharyngitis, dyskinesia, fall and bone fracture. 

CVT-301 is a dry powder inhalation of levodopa designed to deliver precise doses directly to the brain through the lungs. Inhalation of medication may reduce variability in absorption and onset of medication, bypassing gastrointestinal metabolism observed in oral medications. As an adjunct to maintenance carbidopa/levodopa therapy, CVT-301 may potentially improve the quality of life of approximately 350,000 patients who experience off periods.

Acorda plans to submit a New Drug Application (NDA) by the end of Q2 2017.

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