• 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

Endo pulls painkiller from the market following FDA request

July 6, 2017 By Sarah Faulkner

EndoEndo Pharmaceuticals (NSDQ:ENDP) said today that it will voluntarily pull its Opana ER painkiller from the market. The move comes just weeks after the FDA asked the company to pull the plug on its opioid, arguing that the benefits of the abuse-deterrent drug no longer outweigh the risks.

To write off the remaining net book value of the product, Endo said it expects to incur a pre-tax impairment charge of $20 million in the 2nd quarter of this year. Opana brought in $158.9 million in net sales in 2016.

The company stands by the safety and efficacy of its pain-relief product.

“Endo reiterates that neither the FDA’s withdrawal request nor Endo’s decision to voluntarily remove Opana ER from the market reflect a finding that the product is not safe or effective when taken as prescribed,” the company wrote in a statement. “To the contrary, Endo remains confident in the clinical research and other data demonstrating Opana ER’s safety and efficacy, as well as its favorable risk-benefit profile when used as intended in appropriate patients.”

The request from the FDA to remove Opana from the market marked the first time the federal regulatory watchdog urged a company to remove an opioid due to concerns of abuse.

Endo’s Opana ER won FDA approval in 2006 for the management of moderate-to-severe pain. Six years later, the company reformulated Opana ER with the intent to make it harder for people to snort or inject it.

But a review of postmarketing data showed that the reformulation may have encouraged users to shift from snorting Opana to injecting the painkiller by mixing it with large volumes of solvent.

The painkiller was even linked to a 2015 HIV outbreak in Indiana after people addicted to opioids shared needles while injecting Opana.

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Filed Under: Featured, Food & Drug Administration (FDA), Pain Management, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Endo Pharmaceuticals

IN CASE YOU MISSED IT

  • Medtronic to separate Diabetes business unit
  • Tandem Diabetes Care wins CE mark for Mobi insulin pump with Control-IQ+ technology
  • Glooko adds chief strategy officer to chief medical officer’s title
  • Cordis launches 10,000-patient registry for drug-eluting balloon
  • Senseonics opens $50M public offering, $25M private placement with Abbott

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