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.
Get the full story on our sister site, Drug Delivery Business.
The post FDA nixes Evoke Pharma’s gastro nasal spray appeared first on MassDevice.