Zosano Pharma begins enrolment in pivotal clinical trial of ZP-Triptan to treat acute migraine
US-based pharmaceutical company Zosano Pharma has enrolled its first patient in its pivotal clinical trial of ZP-Triptan patch treatment to treat acute migraine.
US-based pharmaceutical company Zosano Pharma has enrolled its first patient in its pivotal clinical trial of ZP-Triptan patch treatment to treat acute migraine.
ZP-Triptan is a patented, zolmitriptan-coated, microneedle patch applied onto the patient's upper arm to deliver zolmitriptan during a migraine attack.
The multicentre, randomised, placebo-controlled trial is expected to enrol 360 patients within about 35 centres across the US.
The trial is designed to assess the efficacy of ZP-Triptan patch treatment by comparing three doses of ZP-Triptan to placebo for the treatment of a single migraine attack.
"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."
It focuses on two co-primary endpoints that include relief from pain after two hours post dosing, as well as remission of symptoms at two hours post-dosing.
Zosano president and CEO Konstantinos Alataris said: "Commencing the pivotal efficacy trial for ZP-Triptan for migraine is a significant milestone as we transition the programme to its anticipated final stage of development and reiterate that we expect to report pivotal efficacy data in 1Q2017.
"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 Pharma is planning to conduct a safety study of the product following completion of the pivotal efficacy study.