Zosano to Present Additional Analyses from the ZOTRIP Pivotal Study on Pain Relief and Recurrence at the 2018 American Headache Society (AHS) Meeting
Key findings on receptor and binding kinetics also to be presented in a poster and oral presentation
“The combination of fast onset of pain relief and low headache recurrence from a migraine attack treatment has rarely, if ever, been reported in previous triptan trials. Generally, triptans that have had a fast onset of pain relief have had a high headache recurrence rate, making their use less than optimal,” said lead presenter
As previously announced, the ZOTRIP Phase 2/3 clinical study of ADAM™ zolmitriptan for the acute treatment of migraine achieved statistically significant and clinically meaningful results of primary endpoints which included 41.5% pain freedom at two hours compared to placebo and 68.3% relief of most bother symptom at two hours compared to placebo. 81% of subjects achieved pain relief at two hours and was sustained through 24 hours. The most commonly reported adverse events were application site erythema which generally resolved within 48 hours and bruising. In
PF50: Rapid Systemic Absorption of Zolmitriptan from M207 is Associated with a High Rate of Pain Relief and a Low Incidence of Moderate or Severe Pain Recurrence
PS80: Analysis of Ligand-Receptor Kinetics of Zolmitriptan, its Primary Metabolite, and Sumatriptan
Oral Presentation: Binding Kinetics of Zolmitriptan, N-desmethyl-zolmitriptan and Sumatriptan
M207 is our proprietary formulation of zolmitriptan delivered utilizing Zosano's proprietary ADAM technology. Zosano's ADAM technology consists of titanium microprojections coated with drug, and in the case of M207, our formulation of zolmitriptan. Our ADAM technology delivers drug by abrading the stratum corneum and allowing drug to be absorbed into the microcapillary system of the skin. In February 2017, the Company announced statistically significant results from the ZOTRIP pivotal study, which demonstrated that the 3.8mg dose of M207 met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at two hours. In November 2017, the Company announced the initiation of its long-term safety study evaluating M207 and expects to file an NDA for M207 in the fourth quarter of 2019.
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Chief Executive Officer and Chairman of the Board
Source: Zosano Pharma Corporation