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FREMONT, Calif. – March 4, 2020 (Investorideas.com Newswire) Zosano Pharma Corporation (Nasdaq: ZSAN), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for Qtrypta™ for filing and substantive review.
The Prescription Drug User Fee Act goal date for the completion of the FDA’s review of Qtrypta™ is set for October 20, 2020. This date reflects a standard 10-month review period and is consistent with the review timeline for a 505(b)(2) NDA submission.
“The FDA’s filing of our NDA represents a significant milestone and an important step for Zosano and Qtrypta toward our goal of bringing an innovative therapy that we believe can make an important difference in the lives of patients who suffer from migraine. We believe Qtrypta, if approved, has the potential to offer patients rapid, sustained pain relief with no recurrence,” said Steven Lo, President and Chief Executive Officer of Zosano. “This submission also represents the first NDA to be submitted to the FDA for a pharmaceutical microneedle patch. We believe this technology, if approved, has the potential to transform how drugs, biologics and vaccines are delivered, and we look forward to further discussions with the FDA during its review of this submission. We are grateful for the patients who participated in our clinical trials, our clinical investigators and the entire Zosano team who have helped us realize this significant milestone.”
“Migraine is a chronic and disabling neurological disease, affecting several areas of the brain and its blood vessels. Many patients are unsatisfied with their current acute treatment options. Migraine can significantly impair functional ability at work or school with devastating impact to the patient’s quality of life,” said Alan M. Rapoport, M.D., a Clinical Professor of Neurology at the David Geffen School of Medicine at UCLA. “I believe Qtrypta, if approved, will offer patients with difficult to treat migraine attacks a new, non-oral treatment option that gives them confidence and control over their attacks and ability to get back to life.”
The NDA is supported by the clinical results of the ZOTRIP pivotal Phase 2/3 clinical study, which evaluated the efficacy, safety and tolerability of Qtrypta™ compared to placebo. A total of 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 also at 2 hours, both of which were co-primary endpoints. Additionally, 80.5% of patients reported pain relief at 2 hours, a secondary endpoint. The results of the study were published in Cephalalgia in October 2017.
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