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Zosano Pharma doses first subject in efficacy trial of M207 patch for acute migraine

MDBR Staff Writer Published 26 July 2016

Zosano Pharma has dosed first subject in registration-enabling pivotal efficacy trial of its M207 patch, formerly known as ZP-Triptan, to treat acute migraine.

The M207 zolmitriptan-coated microneedle patch is designed to rapidly deliver zolmitriptan during a migraine attack.

During phase I trial, the M207 showed its faster absorption kinetics when compared to oral zolmitriptan. 

The company expects the M207's injection-free mode of delivery could provide an attractive solution for acute migraine sufferers.

Zosano Pharma president and CEO Konstantinos Alataris said: “We are pleased with enrollment to date and reiterate that trial results are expected to be reported in the first quarter of 2017.”

Of the total 136 enrolled subjects in the trial, 109 are in the run-in phase while 7 subjects have been randomized.

Zosano plans to treat 360 subjects in the efficacy trial, also known as Zotrip trial, at approximately 35 centers across the US.

As part of the ongoing Zotrip multicenter, double-blind, randomized, placebo-controlled trial, the company will compare three doses of M207 (1.0mg, 1.9mg, and 3.8mg) to placebo for the treatment of a single migraine attack.

Alataris earlier said: "We believe the fast absorption kinetics of ZP-Triptan demonstrated in our Phase I trial have the potential to translate into rapid pain relief for migraine sufferers. 

“If established, a rapid pain relief profile coupled with ZP-Triptan's simple injection-free mode of delivery may provide migraine sufferers with an attractive treatment solution."

Zosano is required to complete single, positive, pivotal efficacy study as well as a safety study, as indicated by US FDA, for approval under the 505(b)(2) pathway. 

The safety study is planned to be carried out upon completion of the pivotal efficacy study.