23 December 2019 - Zosano Pharma today announced the submission of a 505(b)(2) new drug application for Qtrypta to the U.S. FDA for the acute treatment of migraine.

Based on Zosano’s submission on 20 December 2019, the company expects to receive notification from the FDA confirming whether the submission was accepted for filing for substantive review in March 2020.

The submission is supported by the results of the ZOTRIP pivotal Phase 2/3 clinical study, in which 41.5% of patients treated with the 3.8 mg dose of Qtrypta achieved pain freedom at 2 hours and 68.3% reported freedom from most bothersome symptom at 2 hours, both of which were co-primary endpoints.

Read Zosano Pharma press release