US FDA to decide this year on application for opioid addiction therapy

16 July 2018
addiction_pills_syringe_big

Sweden’s Camurus (Nasdaq: CAMX) says the US Food and Drug Administration has provided an action date of December 26, 2018 for the firm’s regulatory filing for CAM2038, an investigational opioid use disorder (OUD) treatment.

The firm, and its North American development partner Braeburn Pharmaceutical (Nasdaq: BBRX), received a setback in January after the FDA requested additional information to complete its review.

After the application was re-filed, Camurus said: “The FDA considers the resubmission of the New Drug Application by Camurus' US partner Braeburn a complete response” to the agency’s request.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Pharmaceutical