Zosano Pharma has outlined plans to resubmit its migraine patch for FDA approval by the end of the year. The FDA rejected the drug-device combination Qtrypta last year, forcing Zosano to gather more pharmacokinetic data on the candidate before reseeking approval.
California-based Zosano shared an update on its path back to the FDA this week. Zosano now has FDA feedback on the protocol of its pharmacokinetic trial and an agreement with Worldwide Clinical Trials for the conduct of the study. With the study set to start in June, Zosano expects to have data in the third quarter and resubmit its application for approval by the end of the year.
The FDA requested additional pharmacokinetic evidence on Qtrypta, which uses microneedles to deliver zolmitriptan into the blood, after noting unexpectedly high plasma concentrations of the drug in five volunteers.
Zosano plans to gather comparative pharmacokinetic and safety data from 48 healthy volunteers to address the issue. Donald Kellerman, vice president of clinical development and medical affairs at Zosano, said the study will address “the last remaining clinical request from FDA regarding the resubmission of our NDA” and expressed optimism that Worldwide can quickly execute the trial.
Zosano filed for approval of Qtrypta in December 2019 and disclosed news of the FDA’s acceptance of the submission for review the following March, resulting in a PDUFA date in October 2020. A late 2021 resubmission could see Qtrypta win FDA approval up to two years later than originally planned.
If Qtrypta wins approval, it will enter the increasingly congested acute migraine market. The toolkit for treating acute migraines has expanded in recent years as the FDA has approved drugs such as AbbVie’s Ubrelvy, Biohaven’s Nurtec ODT and Eli Lilly’s Reyvow.
Those drugs are facilitating the treatment of acute migraine via mechanisms such as 5-HT1F receptor agonism and CGRP receptor antagonism. Qtrypta, in contrast, delivers an old active ingredient—zolmitriptan was first approved as Zomig in 1997—in a way that is designed to accelerate the onset of relief from migraine pain.