Civitas Therapeutics has initiated a 28-day Phase 2b efficacy and safety study of CVT-301 inhaled levodopa for the treatment of intermittent motor fluctuations in Parkinson’s patients, the company said. The study is partially funded by a $1 million grant from the Michael J. Fox Foundation for Parkinson’s Research. Civitas announced positive results from a Phase 2a study of the drug in April 2013.
Civitas Chief Medical Officer Martin Freed commented, “We are excited to move to this next stage of development in which patients will self-administer CVT-301 upon the emergence of their OFF symptoms as they go about their normal daily activities, exactly aligned with the intended treatment paradigm. The ease of use of the simple Arcus inhaler allows patients to use CVT-301 wherever and whenever their oral Parkinson’s medications begin to fail them in between their regularly scheduled doses.”
The company said that it plans to report preliminary data from the Phase 2b study by mid-2014.
Read the Civitas press release.
