Zosano says Qtrypta long-term study shows ‘well-tolerated safety profile’
Zosano Pharma (ZSAN) announced earlier today the completion of the second and final goal of the long-term safety study for Qtrypta, in which patients treated migraine attacks over a one year period.
“The long-term data generated in this trial reinforced the well-tolerated safety profile and strong efficacy results previously reported in the six-month dosing portion of this safety study and in the randomized Phase 2/3 ZOTRIP pivotal study,” the company said in a statement.
Throughout the clinical program, over 5,800 migraine attacks have been treated with Qtrypta to date, it added.
The Qtrypta long-term safety trial is an open-label study evaluating the safety of the 3.8 mg dose of intracutaneous zolmitriptan in adults with migraine who have historically experienced at least two migraine attacks per month.
The study evaluated over 150 adults with migraine disease for six months, and more than 50 patients for a year at 31 sites in the U.S.
Of more than 5,800 migraines treated, investigators reported 832 adverse events, of which 298 were reported as application site reactions and 161 were reported as triptan related adverse events.
Observational efficacy parameters continued to demonstrate a rate of pain freedom at two hours following patch application of approximately 44% and most bothersome symptom freedom of approximately 68%, while pain relief at two hours was reported at 81% of migraine attacks treated, said Zosano.
The company expects to file an New Drug Application for Qtrypta in the fourth quarter of 2019.
ZSAN is up 95% to $4.41.
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