Further FDA setback for QRxPharma’s MoxDuo
In yet another setback for Australia-based QRxPharma (ASX: QRX),the US Food and Drug Administration has issued a second complete response letter (CRL) regarding the MoxDuo (morphine and oxycodone) New Drug Application for the treatment of moderate to severe acute pain.
The agency stated that there was not sufficient evidence to support approval of MoxDuo at this time. The FDA, which delayed approval of the drug combination with a CRL last year (The Pharma Letter August 29, 2013), indicated clinical information demonstrating a clear benefit over oxycodone and morphine alone, either by efficacy, or safety, in an appropriate patient population, is needed.
The company says it is presently reviewing the agency's feedback and will request a meeting with the FDA to clarify the steps required for approval.
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 accountTry before you buy
Free
7 day trial access
- 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
- 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
Today's issue
Company Spotlight
More Features in Pharmaceutical
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze