FDA Rejects Axsome Migraine Medication, But Problems Are Addressable

FDA Rejects Axsome Migraine Medication, But Problems Are Addressable

May 2nd, 2022 // 11:08 pm @

FDA rejected Axsome Therapeutic’s migration medication last week, which was expected after the firm reported there were problems with CMC (chemistry, manufacturing, and controls) that were unresolved, according to FDA.

the rejection of Axsome’s AXS-07 through a complete FDA response letter was announced by the company yesterday during its Q1 earnings report. But the company added that the CMC problems could be addressed in a future NDA.

Axsome added that FDA didn’t flag problems with clinical trials or drug safety data. It added it would update the industry and shareholders on when it would submit a new NDA.

The regulatory issues came to light after Axsome noted in Feb. 2022 that an FDA inspection of drug manufacturing process would be possible before the deadline of April 30. In the past, the FDA inspection was delayed because of COVID-19.

Axsome did not say if the regulatory issues were raised during the audit.

For investors, AXS-07 developments have been a backburner issue as AXS-05 was highly anticipated. This is the firm’s drug for major depressive disorder.

In March, Axsome told the media that it agreed with FDA regarding postmarketing requirements after it responded to issues that FDA raised in 2021.

A decision by FDA is expected later in 2022. AXS-05 is being evaluated for smoking cessation and Alzheimer’s disease agitation.

Axsome also is on schedule to have a drug to treat fibromyalgia in 2023.

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