Zosano Pharma Corp a clinical stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to subjects using its proprietary Adhesive Dermally-Applied Microarray (“ADAM”) technology, announced that Cephalalgia had published the Company’s positive results from our pivotal, multi-center, double blind, placebo controlled, trial demonstrating efficacy and safety of M207, our formulation of zolmitriptan using our ADAM technology.
ADAM is Zosano Pharma’s proprietary, investigational technology platform designed to offer rapid drug absorption into the bloodstream, which can result in an improved pharmacokinetic profile compared to original dosage forms. ADAM consists of an array of drug-coated titanium microprojections mounted on an adhesive backing that is pressed on to the skin using a reusable handheld applicator. The microprojections penetrate the stratum corneum and allow drug to be absorbed into the microcapillary system of the blood.
Cephalalgia published a paper titled “Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Safety and Efficacy of ADAM Zolmitriptan for the Acute Treatment of Migraine”, which contained the positive results from Zosano’s ZOTRIP pivotal study. ZOTRIP was a multicenter, double-blind, randomized, placebo-controlled trial comparing three doses of M207 (1.0mg, 1.9mg, and 3.8mg) to placebo for the treatment of a single migraine attack. In this study of 365 migraineurs, the 3.8mg dose of M207 demonstrated a statistically significant benefit in both freedom from pain and freedom from a patient’s most bothersome symptom (photophobia, phonophobia or nausea and vomiting) at the 2 hour pre-specified primary endpoint. Secondary endpoints demonstrated pain freedom at 45 min after administration, with an effect that was sustainable for 48 hours post treatment. The majority of adverse events were mild or moderate application site reactions. There were no serious adverse events. Zosano announced the results of the ZOTRIP trial in February 2017.
“We are grateful for the contributions of our investigators, co-authors and advisors on the design, execution, analysis and reporting of the ZOTRIP trial,” said Dr. Don Kellerman, Vice President of Clinical Development. “We believe that the time from topline results to peer-reviewed publication in a prestigious journal reflects the design of the study and the unambiguous results.”
"We are pleased to have the results of ZOTRIP, our pivotal study, published in Cephalalgia," stated John P. Walker, Zosano’s Chairman and Chief Executive Officer. "The recognition of the results from ZOTRIP in such a well-known journal will continue to raise awareness of M207, and its ability to address an unmet need for patients struggling to find rapid and durable pain relief for migraine episodes.”
