• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

FDA nixes Evoke Pharma’s gastro nasal spray

April 3, 2019 By Nancy Crotti

(Photo by Kai Pilger on Unsplash)

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.

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Women's Health Tagged With: evokepharma, FDA

IN CASE YOU MISSED IT

  • Omnipod 5 rollout for type 2 rolls on as Insulet pursues next-gen automation
  • LifePlus reports clinical validation of non-invasive glucose, blood pressure monitor
  • Abbott Diabetes head talks Medtronic partnership, exciting times ahead
  • PharmaSens, SiBionics innovatively combine tech in all-in-one insulin patch pump
  • Study backs Biolinq intradermal sensor in muscle loss prevention during GLP-1 therapy

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS