Axsome Therapeutics AXS-05 Priority Review by FDA Could Speed Up Help for MDD Patients


The U.S. Food and Drug Administration (FDA) has granted Priority Review to Axsome Therapeutics’ AXS-05 (dextromethorphan-bupropion). The accelerated review framework shortens the review duration from a standard 10-month period down to six months after its New Drug Application (NDA) acceptance.

In keeping with Axsome’s mission of providing a solution for central nervous system (CNS) disorders that are difficult to treat, AXS-05 was developed to help patients exhibiting  treatment-resistant depression (TRD) and major depressive disorder (MDD). It is also designed to address Alzheimer’s disease (AD) agitation and to encourage smoking cessation.

“We are pleased with the FDA’s acceptance and Priority Review designation of our NDA for AXS-05 in major depressive disorder, and we look forward to continuing to work closely with the FDA throughout the review process,” said Axsome CEO Herriot Tabuteau, M.D.

He further said that AXS-05 will be a key treatment for depression among Americans who are struggling with the condition.

Research on major depressive disorder (MDD), also known as clinical depression, suggests that the condition may be caused by the combination of such factors as genetics, biology, environment, and psychology. Trauma, stress, illnesses are among the risk factors associated with MDD.

The completed COMET-SI clinical trials of the AXS-05 demonstrated that treatment of patients, who have MDD, using the novel drug swiftly reduced suicidal ideation. Progress was gauged by observing lowered MADRS-SI (Montgomery-Åsberg Depression Rating Scale- Suicidal Ideation) scores among the participants.

Axsome’s investors are suitably pleased. The New York biopharmaceutical company’s stock price has gone up since news of AXS-05’s filing acceptance and of its ensuing accelerated review. In March 2019, AXS-05 was granted Breakthrough Therapy Designation by the FDA for the treatment of MDD. In June 2020, it was given the same designation for the treatment of AD agitation.

Studies suggest evidence that link MDD with AD such that development of the former indicates the likelihood of developing the latter. Primarily, the brain areas that are affected by major depressive disorder are same areas that are affected by Alzheimer’s disease. In the presence of either disease, the levels of neurotransmitter chemicals in the brain have been observed to be low.

For AD patients, AXS-05 targets the reduction of episodes of agitation associated with the condition. Clinical trials under the ADVANCE phase delivered a positive trend toward the treatment of Alzheimer’s-associated agitation. The results were measured using Cohen-Mansfield Agitation Inventory (CMAI) scoring. ACCORD, which is phase 3 of the study, focuses on observing the interval between administration of AXS-05 and the patient’s relapse to agitation.

No treatment has been approved to treat AD agitation despite its debilitating effect on individuals. Tabuteau highlights, “If successfully developed, AXS-05 has the potential to address this high unmet need and significantly improve the lives of patients and their caregivers.”

Congruently, use of AXS-05 has also been trialed among smokers to understand its effect on smoking cessation. Participants who received the treatment displayed a significantly reduced level of expired carbon monoxide, which is the biochemical marker that indicates smoking frequency.

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