Zosano Announces Positive Data from a Nonclinical Evaluation of Pharmacokinetics and Skin Tolerability Study for ADAM™ Technology for the Delivery of Zolmitriptan
- Peer-reviewed article published in
Journal of Pharmaceutical Scienceevaluates skin tolerability and bioavailability of ADAM’s intracutaneous zolmitriptan delivery
“This study enabled us to understand the delivery and tolerability of M207 in a nonclinical setting so as to aid us in setting reasonable expectations of our platform when studying in human subjects,” said
In vivo studies were conducted in pigs using ADAM 1.9-mg zolmitriptan. Pharmacokinetic studies showed that the ADAM 1.9-mg zolmitriptan was delivered with high efficiency (85%) and high absolute bioavailability (77%). Furthermore, in vivo evaluation showed a rapid systemic absorption with a median Tmax of 15 min. These results provided validation to advance the development of ADAM zolmitriptan.
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. The drug-coated microneedles physically break through the stratum corneum and penetrate into the epidermis and dermis, where the dry drug coating is dissolved by the surrounding skin interstitial fluid. 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 2 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