The FDA has rejected Evoke Pharma’s (NSDQ:EVOK) application for a metoclopramide nasal spray for diabetic women with gastroparesis.
The Solana Beach, Calif. company’s stock price tumbled 40% on the news yesterday that the agency had found dosing inconsistencies in the pivotal pharmacokinetic study for the spray, Gimoti. In an earlier multi-disciplinary letter to the company, the FDA had cited concerns with quality control, dosing, and a lack of information to support sex-based differences in efficacy.
“We believe that the issues cited in the (complete response letter), which were related to concerns over reproducible dose delivery, can be addressed,” said Evoke Pharma said president & CEO Dave Gonyer in a prepared statement. “We look forward to meeting with FDA to gain a full understanding of the Agency’s requirements for approval and remain committed to bringing our novel nasal formulation of metoclopramide to patients.”
Oral and intravenous metoclopramide have been available since 1980. Gimoti would be the first nasal spray formulation of the drug, which was developed to aid in the movement of food through the digestive system.
Gastroparesis disproportionately affects adult women and is characterized by slow or delayed gastric emptying of the stomach’s contents after meals, often resulting in flares of symptoms that include nausea, vomiting, abdominal pain and bloating. Vomiting and gastric emptying delays can cause unpredictable absorption of food and oral medications, which complicate glucose control and can lead to dehydration and malnutrition.
If approved, Gimoti would represent the first significant advancement in the treatment of gastroparesis in 40 years, according to the pharmaceutical company.