Evoke Pharma says that it recently had a positive pre-NDA meeting with the FDA regarding clinical data to be included in its planned 505(b)(2) NDA for Gimoti intranasal metoclopramide for the treatment of diabetic gastroparesis in adult women. The meeting was the second regarding Gimoti.
After the first meeting, Evoke announced that it planned to move ahead with the NDA despite the fact that a Phase 3 trial of Gimoti had failed to meet its primary endpoint. For the second meeting, the company said that it “provided Phase 3 data that showed statistically significant efficacy compared to placebo for patients with moderate to severe symptoms at baseline in a post-hoc analysis.”
According to Evoke, the FDA will allow the company to conduct a PK trial in healthy volunteers and submit evidence of bioequivalence to oral metoclopramide as part of the NDA. The agency would not require any new efficacy or safety data in that case.
Evoke Pharma President and CEO Dave Gonyer commented, “Our meeting with the FDA represents another positive step forward for our clinical program and our path to an NDA submission. With the FDA’s guidance, Evoke intends to complete an additional pharmacokinetic trial and file an NDA, without the need for additional efficacy studies. Given these two positive pre-NDA meetings, we believe the company is well-positioned to move forward to an NDA and potential approval of Gimoti for diabetic gastroparesis in adult women.”
Read the Evoke Pharma press release.
