Evoke Pharma Inc. said the U.S. Food and Drug Administration accepted the resubmitted new drug application for its spray Gimoti to treat a gastrointestinal disorder called gastroparesis.
Gastroparesis is a condition characterized by delayed emptying of the stomach contents after meals, and symptoms include heartburn, nausea and vomiting. Patients with the disorder feel full quickly when eating.
The U.S. regulator rejected an earlier application for the drug in April 2019 and asked the Solana Beach, Calif.-based pharmaceutical company to address issues related to clinical pharmacology as well as product and device quality.
Evoke resubmitted the application for Gimoti to treat symptoms in adult women with acute and recurrent diabetic gastroparesis in December 2019. The application included an in-depth cause analysis along with patient use and experience data from the clinical trials to address the regulator's concerns.
Additionally, the company included three-month data from commercial-scale batches that meet all product specifications and criteria for performance characteristics and device quality control.
The FDA expects to complete the review during a six-month period and issue a decision on Gimoti by June 19.