Zosano Pharma (ZSAN) Announces Publication of Clinical Data Regarding Long-term use of Qtrypta for Treatment of Acute Migraine in The Journal of Headache and Pain
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Zosano Pharma Corporation (NASDAQ: ZSAN), a clinical-stage biopharmaceutical company, today announced that an article titled, “Long Term Safety, Tolerability, and Efficacy of Intracutaneous Zolmitriptan (M207) in the Acute Treatment of Migraine” was published in The Journal of Headache and Pain. This open-label, multicenter observational study was designed to evaluate the safety and efficacy of the repeated use of Qtrypta™ in adults with migraine who had historically experienced at least 2 migraine attacks per month. The tolerability and efficacy results in this long-term study were consistent with the results observed in the Phase 2/3 ZOTRIP study.
“The data published provide safety and efficacy findings for Qtyrpta™ when given repeatedly over the course of a year for the acute treatment of migraine,” said Don Kellerman, PharmD, vice president of clinical development and medical affairs of Zosano. “The similarity of these findings with those from the pivotal ZOTRIP study -- across primary and secondary outcome measurements -- provide supportive evidence regarding the performance of Qtrypta™, and if approved, its potential as a valuable long-term treatment option for patients.”
Stephanie J. Nahas, MD, MSEd, FAHS, FAAN, Associate Professor of Neurology at Thomas Jefferson University and Director of the Headache Medicine Fellowship Program, added, “In this long-term study, participants experienced on average about two migraine attacks per month and achieved meaningful relief with Qtrypta recurrently without serious side effects. If approved, I believe Qtrypta™ may be welcomed by many patients who need a better acute attack plan for their migraine.”
A total of 335 participants treated at least one migraine attack, and in total 5,963 migraine attacks were treated over the course of the study. The primary outcome measure was the percentage of participants experiencing treatment emergent adverse events over 12 months. Secondary outcomes included the percentage of migraine attacks for which pain freedom and most bothersome symptom freedom were achieved at two hours post-dose, and the percentage for which pain relief was achieved at two hours post-dose.
Participants achieved pain relief at two hours post-dose in 81% of migraine attacks, pain freedom in 44% of attacks, and most bothersome symptom freedom in 62% of attacks. The majority of participants experienced cutaneous application site reactions where the Qtrypta patch was applied, of which more than 95% were rated as mild. More than 80% of swelling and redness incidents were resolved (rated as zero) by 48 hours following application.
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