FDA Grants Depression Drug Fast Track Designation

The FDA recently granted AXS-05 fast track designation for patients with treatment-resistant depression. AXS-05 is currently being investigated in the STRIDE-1 phase 3 clinical trial to determine the efficacy and safety of the drug, according to a press release from Axsome Therapeutics.

The drug is being developed for central nervous system disorders, and uses a combination of bupropion and dextromethorphan.

Dextromethorphan is an NMDS receptor antagonist, sigma-1 receptor agonist, and inhibits serotonin and norepinephrine transporters, while bupropion increases the bioavailability of dextromethorphan. Bupropion is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist.

Patients with major depressive disorder are characterized as having treatment-resistant depression if they have failed 2 or more antidepressants, according to Axsome. Approximately two-thirds of these patients do not respond to first-line therapy, and may also go on to fail additional treatments.

“Treatment resistant depression is debilitating and life-threatening for patients, while also being distressing for family members. Unfortunately, there are few viable options for patients living with depression if initial treatments do not work,” Maurizio Fava, MD, slater family professor of Psychiatry at Harvard Medical School and executive vice chair of the Department of Psychiatry at Massachusetts General Hospital, said in a previous press release. “Research into potential new medications with novel mechanisms of action is critical to addressing this public health need.”

The positive data submitted to the FDA lead to the fast track designation for AXS-05. Fast track designation is reserved for drugs that may treat serious conditions where there is a clinically unmet need. This program allows the FDA to approve new drugs for these conditions on an expedited basis.

In addition to being explored in depression, AXS-05 is also being explored in patients with agitation related to Alzheimer’s disease. Axsome hopes that the fast track designation will provide a treatment option for patients with depression who have tried multiple other drugs.

“At least three million individuals in the US alone are estimated to be living with treatment resistant depression, a condition associated with potentially devastating consequences,” said Herriot Tabuteau, MD, chief executive officer of Axsome. “The decision by the FDA to grant Fast Track status for AXS-05 for treatment resistant depression underscores the limited treatment options for this serious condition and the potential for AXS-05 to address this unmet medical need. We look forward to continued progress with our ongoing STRIDE-1 trial of AXS-05 in treatment resistant depression.”