Evoke Pharma Inc. resubmitted a new drug application with the U.S. Food and Drug Administration seeking approval of its nasal 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 Gimoti to treat symptoms in adult women with acute and recurrent diabetic gastroparesis in April. In its complete response letter, the FDA recommended the company to address issues related to clinical pharmacology as well as product and device quality.
The clinical pharmacology issue was related to a low Cmax — the maximum serum concentration that a drug achieves after being administered — in patients, which represented less than 5% of the total administered Gimoti doses in the study. The FDA also requested that the company provide data from the planned registration batches of the commercial product that would be manufactured.
The Solana Beach, Calif.-based pharmaceutical company said the latest application includes an in-depth cause analysis along with patient use and experience data from the clinical trials to address the regulator's concerns regarding Gimoti's clinical pharmacology.
Evoke added that the application contains three-month data from commercial-scale batches that meet all product specifications and criteria for performance characteristics and device quality control.
Shares of Evoke were down 7.81% to $1.45 as of 10:43 a.m. ET on Dec. 20.