Zosano Pharma announces publication of Qtrypta analysis
Zosano Pharma announced the peer-reviewed publication of a review and analysis of recently-completed trials using newly FDA-recommended endpoints in the acute treatment of migraine. The review article was published in Headache. In this analysis, researchers reviewed eight published trials designed in accordance with the Guidance for Industry, that recommended using co-primary endpoints of pain freedom and freedom from most bothersome symptom, or MBS, at 2-hours post-treatment. Using the placebo response rates from these various trials, the authors were able to calculate required sample sizes for future trials and compare these calculations to the sample sizes actually used in completed trials. Included in this analysis was Zosano's ZOTRIP trial, in which 41.5% of subjects in the Qtrypta 3.8mg arm achieved pain freedom at two hours and 68.3% achieved freedom from their MBS at two hours, as compared to 14.3% and 42.9% respectively in the placebo group. Furthermore, the analysis showed that the average response rates across all active groups of these trials were 30.4% for pain freedom and 46.7% for MBS freedom, compared to 16.8% and 33% respectively for the placebo groups. Using these averages, future trials would need to enroll approximately 180 subjects per arm to demonstrate statistical significance with 80% power. Researchers noted that the majority of the completed trials enrolled far more than this, with subjects per group reaching as high as 751.