Dec. 23, 2019: Zosano Pharma Corporation announced the submission of a 505(b)(2) New Drug Application (“NDA”) for Qtrypta™ to the U.S. Food and Drug Administration (“FDA”) for acute treatment of the migraine.
This NDA submission represents a considerable milestone for Zosano and a culmination of our efforts to make Qtrypta available to patients who suffer from migraine.
After clinical trials, Qtrypta demonstrated robust freedom from pain and most bothersome symptom, rapid and sustained pain relief for the patients suffering from migraine.
This 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 inconvenient symptom at 2 hours, both of which were co-primary endpoints.
Qtrypta is Zosano’s proprietary formulation of the zolmitriptan delivered utilizing its proprietary Adhesive Dermally-Applied Microarray (ADAM) technology.
Zosano’s ADAM technology consists of titanium microneedles coated with the drug, and in the case of Qtrypta, its formulation of zolmitriptan. https://fda.einnews.com/pr_news/505583850/zosano-announces-fda-submission-of-new-drug-application-for-qtrypta
