Amphastar plunges on receipt of CRL for opioid overdose drug

22 February 2017

Amphastar Pharmaceuticals’ (Nasdaq: AMPH) stock plunged 21% to $14.57 a share on Tuesday, after the company revealed it had received a complete response letter (CRL) from the US Food and Drug Administration regarding its opioid overdose drug.

The CRL for its New Drug Application for Intranasal Naloxone, indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, identifies issues including user human factors study, device evaluation, and other items that need to be addressed before the NDA can be approved. This means the drug will not be approved in its present form. I

Amphastar's chief executive Dr Jack Zhang, stated: "While we are disappointed to have not received approval at this time, we intend to continue to work with the FDA to address their concerns in the CRL and hope to bring Intranasal Naloxone to the market as soon as possible.”

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.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

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