Axsome’s oral drug combination delays relapse of depression in phase 2 trial

Axsome Therapeutics’ AXS-05 achieved the primary endpoint of significantly delaying time to relapse of depression in patients with treatment-resistant depression in a phase 2 trial, according to a company press release.

The MERIT study evaluated 44 patients in stable remission after twice-daily oral treatment with AXS-05 (45 mg dextromethorphan and 105 mg bupropion) who were then randomized 1:1 in a double-blind fashion to continued treatment or placebo for at least 26 weeks or until relapse, the release said.

Over 6 months of treatment, no relapses were observed in the treatment group compared with the placebo group (P = .002), and the relapse rate during the double-blind treatment period was 36.4% of patients in the placebo group vs. no patients in the treatment group (P = .004), thus meeting the key secondary endpoint of relapse prevention.

AXS-05, which is an investigational NMDA receptor antagonist with multimodal activity, was considered well-tolerated, and a new drug application for the treatment of major depressive disorder is under priority review with an FDA PDUFA action date set for Aug. 22.

“The need for fast-acting therapies is more pressing in patients with the severe form of the disease, who, in many cases, have to be hospitalized,” Alessio Brunello, managing pharma analyst, said in a press release from GlobalData. “Furthermore, products used for the treatment of depression are associated with significant side effects, including weight gain and sexual dysfunction, and risk factors such as the boxed warning for the risk of suicidality amongst adolescents, which directly affects compliance and subsequently affects treatment efficiency.”

References:

Axsome Therapeutics. Axsome Therapeutics announces AXS-05 achieves primary and key secondary endpoints in the merit phase 2 trial in treatment resistant depression. Available at: https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-axs-05-achieves-primary-and-key. Accessed August 11, 2021.

Global Data. Axsome Therapeutics AXS-05 shows promising results in resistant depression treatment, says GlobalData. Available at: https://www.globaldata.com/axsome-therapeutics-axs-05-shows-promising-results-resistant-depression-treatment-says-globaldata/. Accessed August 11, 2021.