Axsome Therapeutics recently announced that its pipeline product AXS-05 (bupropion + dextromethorphan) achieved primary and key secondary endpoints in the MERIT Phase II Trial for the treatment of resistant depression (TRD). A large number of major depressive disorder (MDD) patients do not respond to the available treatments and are referred to as treatment-resistant. There is a need to develop therapies that target treatment-resistant patients, as well as products that improve remission rates and prevent relapses, says GlobalData, a leading data and analytics company.

Alessio Brunello, Managing Pharma Analyst at GlobalData, comments: “Other than Janssen’s Spravato, which is approved for a limited patient population, none of the marketed products for depression can demonstrate rapid antidepressant effects, and most of the products take weeks to show effectiveness.

“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. 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.”

Few pipeline agents in Phase II of development for MDD and TRD, namely Sage Therapeutics/Biogen’s zuranolone, Axsome Therapeutics’ AXS-05, and Relmada Therapeutics’ REL-1017 are aiming to offer rapid antidepressant effects. Zuranolone, AXS-05, and REL-1017 have novel MOAs and show promise for providing rapid antidepressant effects.

GlobalData anticipates that the most promising pipeline product will be Axsome Therapeutics’ AXS-05, which, with its novel MOA and potentially rapid onset of action, will have the potential to become a blockbuster drug. Currently a new drug application (NDA) for AXS-05 for the treatment of MDD is under Priority Review by the Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2021.

GlobalData forecasts AXS-05 to generate global sales of approximately US$1.3bn by 2027.

Mr Brunello concludes: “KOLs interviewed by GlobalData highlighted that opportunities exist for products that will meet the significant unmet needs in this market. Products that have improved efficacy and safety profiles, and that can show rapid antidepressant effects when compared with available treatments, will be viewed favorably.

“Products with such characteristics will have significant competitive advantages, which would enable them to potentially move to the forefront of the treatment line and gain significant market share. However, it will be a challenge for new, expensive products to compete with the cheap, generic selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) that are very well established on the market.”