Acorda Therapeutics will present data from a Phase 1 study of its CVT-427 zolmitriptan DPI at the Annual Scientific Meeting of the American Headache Society, the company has announced. According to the company, the data show that the bioavailability of CVT-427 exceeded that of oral and intranasal zolmitriptan with lower variability in plasma concentrations. Acorda, which is developing CVT-427 for the treatment of migraine headaches, announced initiation of the Phase 1 trial in December 2015.
Of the 21 healthy adults enrolled in the single ascending dose trial, 17 completed all of the treatments, which included single 5 mg doses of oral and nasal spray formulations of zolmitriptan and 4 doses of CVT-427: 0.825 mg (0.6 mg delivered to the lung), 1.65 mg (1.2 mg), 3.0 mg (2.4 mg), and 6.0 mg (4.8 mg). According to the company, there were no discontinuations due to adverse events, no dose limiting toxicities, and no serious adverse events. The most common adverse event was cough, which occurred in 11-22% of patients for the various doses.
Median Tmax was 0.17 hours for CVT-427 compared to 1.5 hours for the oral formulation and 3 hours for the nasal spray. Mean Cmax ranged from 6.0 ng/m to 35.0 ng/ml for the 4 doses of CVT-427 compared to 8.7 ng/ml for the oral formulation and 8.1 ng/ml for the nasal spray. Mean AUC-24 values for CVT-427 ranged from 14.7-91.0 ng-hr/ml compared to 49.0 for oral and 50.8 for nasal spray.
Acorda Chief Technology Officer Rick Batycky commented, “When surveyed, the majority of migraine sufferers said rapid pain relief is one of the most important factors influencing their medication preference. We’re encouraged by the findings of this PK study, which support advancing development of CVT-427 for the acute treatment of migraine.”
CVT-427 is based on Acorda’s Arcus dry powder formulation and delivery technology, which it acquired when it acquired Civitas Therapeutics in 2014.
Read the Acorda press release.
