According to Evoke Pharma, the FDA has accepted its resubmitted NDA for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis and has set a PDUFA date of June 19, 2020. The original 505(b)(2) NDA was submitted in June 2018, and the FDA issued a complete response letter to that NDA in April 2019. Evoke announced in December 2019 that it had resubmitted the NDA with additional information requested by the agency.
Evoke President and CEO Dave Gonyer commented, “We are pleased that FDA has accepted our NDA resubmission and look forward to working with the agency throughout the review process toward a potential approval. We will now turn our focus to ensuring commercial readiness, as we believe physicians and patients are in urgent need of a new treatment option for the management of diabetic gastroparesis. We remain confident that Gimoti can help fill this unmet medical need and improve the quality of life for patients suffering from this disease.”
Read the Evoke Pharma press release.
