Acorda Therapeutics has now released results from its late-stage clinical trial of CVT-301, an oral inhaler based formulation of levodopa. CVT-301 is being developed as a self-administered, inhaled levodopa (L-dopa) therapy for the treatment of symptoms of OFF periods in people with Parkinson’s disease taking an oral carbidopa / levodopa regimen. The advantage of an administration through the lungs rather than conventional levodopa pills is that the drug does not need to travel through the gastrointestinal tract, but is quickly resorbed and made available through he lungs.
We are greatly encouraged by the efficacy and safety results of this trial, which validate the positive Phase 2b results,” said Burkhard Blank, M.D., Chief Medical Officer of Acorda. We would like to express our gratitude to the study volunteers and clinical investigators who participated in this trial to advance our understanding of this potentially important therapy for people with Parkinson’s.
The study met its primary endpoint with a significant improvement at week 12 on the Unified Parkinson’s Disease Rating Scale-Part 3 (UPDRS III) of -9.83 at the 84mg dose compared to -5.91 on placebo (p=0.009) at 30 minutes post-treatment.
Like in the Phase II study, the safety profile was good. common adverse events were cough, upper respiratory tract infection, throat irritation, nausea and sputum discoloration. Three of 227 participants receiving CVT-301 discontinued the study due to cough. Acorda will present additional lung function data from two other safety studies which will have results during Q1.