Phase III clinical data of CVT 301 (inhaled levodopa) shows improvement in Parkinsons disease patients- Acorda Therapeutics

Acorda Therapeutics announced Phase III clinical data of CVT 301 (inhaled levodopa), showing a statistically significant improvement in motor function in people with Parkinson�s disease experiencing OFF periods. The drug is being studied as a treatment for OFF periods in people with Parkinson�s disease taking an oral carbidopa / levodopa regimen.

The SPAN-PD trial had three arms: CVT-301 84 mg and 60 mg doses (equivalent to 50 mg and 35 mg fine particle doses, respectively), and placebo. The primary endpoint of the study was the change at Week 12 in Unified Parkinson�s Disease Rating Scale-Part 3 (UPDRS III) score relative to placebo at 30 minutes post-treatment for the 84 mg dose. UPDRS III change for the 84 mg dose was -9.83 compared to -5.91 for placebo (p=0.009). UPDRS III is a validated scale, which measures Parkinson�s motor impairment. The safety profile of CVT-301 in this study was consistent with that observed in the Phase IIb trial. Spirometry and diffusing capacity of the lung for carbon monoxide (DLCO) tests showed no notable pulmonary safety signals.

The Company is currently conducting two studies to assess the long-term safety profile of CVT 301. Up to 12-month data from these studies are expected by the end of the first quarter of 2017. The Company plans to file a New Drug Application (NDA) in the United States by the end of the second quarter of 2017, pending results of the long-term safety studies. The Company also plans to file a Marketing Authorization Application (MAA) in Europe by the end of 2017, pending additional data analyses.