Gimoti regulatory update

Evoke said FDA will not require a human factors validation study for Gimoti prior to an NDA submission. The company plans to submit the application by year end to treat the symptoms associated with acute and recurrent gastroparesis in diabetic women. The intranasal formulation of metoclopramide, a dopamine D2 receptor antagonist, has completed a Phase III trial in the indication.

Last year, FDA released guidance requiring drug/device combination products undergo evaluation that may require a human factors study. Evoke said it assessed the need for a human factors study for Gimoti by considering “intended uses, users, use environments, product-user interface, and associated medical factors.” According to Evoke, FDA said the risk assessment was adequate and that a human factors study would not be needed. Last year, Evoke said FDA would require no new efficacy or safety trials for an NDA if the product demonstrated equivalent exposure vs. oral Reglan metoclopramide in a pharmacokinetic trial in healthy volunteers. The company plans to start the trial “as soon as possible” (see BioCentury, Dec. 19, 2016)...