Second fast-acting depression drug looks set for US market

In a filing with the US Securities and Exchange Commission (SEC), central nervous system specialist Axsome Therapeutics (Nasdaq: AXSM) reveals proposed labeling has been received for its depression candidate AXS-05 (bupropion/dextromethorphan).

Shares in the company rose by half following the announcement on Friday, as investor sentiment warmed to the prospect of a positive decision from the US Food and Drug Administration in short order.

Axsome, which is seeking approval to market the novel formulation for major depressive disorder (MDD), said it was “reviewing the proposed labeling and will reply to the FDA to secure final labeling agreement.”

The company has already indicated that it has agreed with the US regulator on certain unspecified post-marketing requirements.

Positive development

AXS-05 targets serotonin, as well as other neurotransmitters, with a novel bupropion and dextromethorphan mix, created using the firm’s metabolic inhibition technology. 

Axsome is looking to tap into an unmet need for fast-acting antidepressants, currently only addressed by Johnson & Johnson (NYSE: JNJ) with its Spravato (esketamine).

The candidate is backed by positive data from the MERIT trial, and Axsome hopes the therapy will be able to help people with MDD who do not respond to currently available treatments.

Industry analyst GlobalData is bullish on the market potential for the therapy, suggesting global annual sales could enter blockbuster territory within five years.

Elsewhere in the firm’s pipeline, the company received a Complete Response Letter (CRL) for its migraine candidate AXS07 (meloxicam/rizatriptan) in early May. 

The FDA said that certain chemistry, manufacturing, and controls (CMC) issues were identified during its review.

Axsome said it “believes that the issues raised in the CRL are addressable,” adding it “intends to provide potential timing for a resubmission following consultation with the FDA.”