FDA nixes Evoke Pharma ’s gastro nasal spray

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.
Source: Mass Device - Category: Medical Devices Authors: Tags: Business/Financial News Drug-Device Combinations Food & Drug Administration (FDA) News Well Pharma Pharmaceuticals Regulatory/Compliance Women's Health evokepharma Source Type: news