Axsome expects CRL on migraine therapy AXS-07

26 April 2022

Central nervous system (CNS) specialist Axsome Therapeutics (Nasdaq: AXSM) revealed that, on April 22, it was informed by the US Food and Drug Administration that chemistry, manufacturing, and controls (CMC) issues identified during the FDA’s review of the company’s New Drug Application (NDA) for its AXS07 (meloxicam and rizatriptan) product candidate for the acute treatment of migraine are unresolved.

Axsome disclosed the news in a regulatory filing with the US Securities and Exchange Commission.

Based upon the time remaining in the NDA review cycle, the company expects to receive a Complete Response Letter with respect to this NDA on or about the Prescription Drug User Fee Act target action date of April 30, 2022.

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