Janssen's Rapid-Onset Antidepressant Nasal Spray Esketamine Hydrochloride Officially Launched in China with 4-Hour Efficacy

Johnson & Johnson announced that itsEsketamine Hydrochloride Nasal Spray, an antidepressant drug, has been officially launched in China.Esketamine hydrochloride nasal spray is the first approved medication for use in combination with oral antidepressants.AlleviateAntidepressants for Depressive Symptoms in Adult Patients with Major Depressive Disorder Accompanied by Acute Suicidal Ideation or Behavior, with a novel mechanism of action and route of administration.

▍About Esketamine Hydrochloride Nasal Spray

Unlike existing antidepressants that mostly act on the monoamine pathway, esketamine hydrochloride nasal spray works throughAntagonize N-Methyl-D-Aspartate (NMDA) ReceptorExerts antidepressant efficacy and adopts intranasal spray administration. Clinical studies show that esketamine hydrochloride nasal spray combined with oral antidepressants can rapidly alleviate depressive symptoms in adult patients with acute suicidal ideation or behavior.

Results from two pivotal global Phase III clinical trials, ASPIRE I and ASPIRE II, indicate that in adult patients with depression accompanied by acute suicidal ideation or behavior, compared to the placebo group,Patients receiving esketamine hydrochloride nasal spray combined with standard treatment showed significant reduction in depressive symptoms within 24 hours, with the effect becoming apparent as early as within 4 hours.Moreover, during the double-blind treatment period, the proportion of patients receiving esketamine hydrochloride nasal spray who achieved remission of depressive symptoms was higher than that of the placebo group at all time points. The severity of suicidal ideation rapidly decreased within 24 hours after the first dose in both groups, but no statistically significant difference was observed between the two.

Safety assessments indicated that most adverse events associated with esketamine hydrochloride nasal spray were mild or moderate and resolved on the day of administration. Regarding the use of the drug,Esketamine Hydrochloride Nasal Spray is restricted to use within medical institutions., and must be administered under the direct supervision of medical personnel. Patients must be observed and monitored after administration.

▍About New Antidepressant Drugs

The China Mental Health Survey shows that the weighted lifetime prevalence of adult depression in China is 3.4%. Studies suggest that among Chinese patients with depression, the lifetime prevalence rates of suicidal ideation and attempted suicide are 53.1% and 23.7%, respectively. The market for antidepressants is vast, according to an analysis by Research and Markets.The global antidepressant market is expected to reach $17.6 billion by 2030, with a compound annual growth rate (CAGR) of 2.5% from 2022 to 2030.

Currently, multiple drugs have been launched globally. Commonly used antidepressants include Lundbeck's Escitalopram, Pfizer's Sertraline, AbbVie's Fluvoxamine, GSK's Paroxetine, Eli Lilly's Duloxetine, and Wyeth's Venlafaxine, among others.

In recent years, more in-depth research on new antidepressant drugs has been conducted globally. For example, in August 2022,Axsome, a U.S. biopharmaceutical companyAuvelity, an antidepressant oral medication, has been approved by the U.S. FDA for the treatment of major depressive disorder (MDD) in adults. It is the world's first new mechanism-based antidepressant oral drug to emerge in over 60 years, creating a new market within the crowded space of older antidepressant medications.AuvelityIt is a compound sustained-release tablet containing dextromethorphan (45mg) and bupropion (105mg), and is the world's first orally fast-acting NMDA (an ionotropic glutamate) receptor antagonist, targeting several neurotransmitters, including glutamate.

On August 4, 2023, the neuroactive steroid γ-aminobutyric acid A (GABAA) receptor positive allosteric modulator co-developed by Biogen and Sage TherapeuticsZuranolone Receives FDA Approval, Becoming the First and Only Oral Treatment for Adult Postpartum Depression (PPD).Zuranolone is an investigational therapy administered once daily over a two-week period., with the potential to rapidly alleviate depressive symptoms within 14 days. Compared to most antidepressants on the market that take about 6-8 weeks to take effect, it shows a differentiation.

Source: Johnson & Johnson Innovation, Pharma Intelligence