Zosano Pharma Presents Early-Onset of Action Data for Qtrypta™ in Acute Treatment of Migraines
- Review of data from the ZOTRIP trial suggest that Qtrypta showed therapeutic gain at 30 minutes consistent with recently published criteria for evaluating early onset of action
- All Qtrypta patients who were pain free at 30 minutes were still pain free at 2 hours
- Observation of pain freedom at 30 minutes was more accurate than the observation of relief at 30 minutes in predicting pain freedom at 2 hours
“We believe Qtrypta shows tremendous potential to become an attractive therapeutic alternative to acutely treat migraines,” said
In a post-hoc retrospective analyses of data from the previously published ZOTRIP trial involving 365 subjects who received Qtrypta 3.8 mg or placebo, of 82 Qtrypta-treated subjects, 38 reported pain relief at 30 minutes, and 28 of the 38 subjects (74%) were pain free at two hours. All 6 subjects treated with Qtrypta who reported pain freedom at 30 minutes were pain-free at two hours. This compares to nine of 26 subjects (35%) in the placebo group (n=77) who reported pain relief at 30 minutes that were pain free at 2 hours, and 1 of 2 subjects that were pain free at 30 minutes being pain free at 2 hours.
These data describe therapeutic gain at 30 minutes, a measure consistent with recently published criteria for evaluating early onset of action published in Cephalalgia, an
“Qtrypta demonstrated rapid and robust improvement in the rates of pain relief and pain freedom in two hours. I believe that rapid onset of meaningful and sustained improvement is of utmost importance to patients suffering from migraines,” said Dr.
About Qtrypta™ (M207)
Qtrypta is Zosano’s proprietary investigational formulation of zolmitriptan delivered utilizing its proprietary transdermal microneedle system (the “System”) in development for the acute treatment of migraine. The System consists of titanium microneedles coated with drug, and in the case of Qtrypta™, the formulation is zolmitriptan. The drug-coated microneedles are designed to penetrate the stratum corneum, where the investigational drug potentially dissolves and easily enters into the bloodstream. In February 2017, the company announced statistically significant results from the ZOTRIP pivotal study, in which the 3.8 mg dose of Qtrypta™ met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours.
Migraine is a highly prevalent neurological disease impacting 12% of the US population and 1 in 4 households. Patients impacted by migraine experience significant disability, with 90% unable to function normally. Migraine attacks are estimated to lead to lost productivity costs as high as $36 billion annually in the
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Chief Financial Officer
Source: Zosano Pharma Corporation