Acorda Therapeutics announced statistically significant results from the Phase 3 study of CVT-301, an investigational inhaled formulation of levodopa, for the treatment of OFF periods in patients with Parkinson’s disease (PD) on an oral carbidopa/levodopa regimen.
SPAN-PD is a randomized, double-blind, placebo-controlled Phase 3 trial evaluating the efficacy and safety of CVT-301 (84mg and 60mg) vs. placebo in 339 Parkinson’s patients who experience OFF periods, which is referred to the re-emergence of motor fluctuations. All patients were on a stable regimen of oral carbidopa/levodopa and maintained on their other existing PD therapies. The primary endpoint was the change in Unified Parkinson’s Disease Rating Scale-Part 3 (UPDRS III) score for the 84mg dose relative to placebo at 30 minutes post-treatment at Week 12. Key secondary endpoints, measured at Week 12, included: the proportion of patients achieving an ON state within 60 minutes of treatment and maintained at 60 minutes; change in UPDRS III score at 10 and 20 minutes following treatment; Patient Global Impression of Change (PGI-C) improvement; and total daily OFF time as recorded in participant diary.
Results showed that treatment with CVT-301 was associated with a statistically significant improvement in motor function vs. placebo in PD patients experiencing OFF periods. The study met its primary endpoint, with a UPDRS III score change of -9.83 for the 84mg dose compared to -5.91 for placebo (P=0.009). The trial also found the safety profile of CVT-301 to be consistent with that observed in the Phase 2b study. The most common adverse events observed were cough, upper RTI, throat irritation, nausea, and discolored sputum. Detailed study results will be presented at a future medical meeting.
CVT-301 is being developed as a self-administered, inhaled levodopa therapy utilizing Acorda’s investigational ARCUS platform to deliver a precise dose of a dry powder formulation to the lung. The Company intends to file a New Drug Application (NDA) for CVT-301 by the end of the second quarter of 2017, pending results of two long-term safety studies.
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