J&J's Next Blockbuster: Esketamine Nasal Spray Approved by FDA for Treatment-Resistant Depression

VCBeat (WeChat ID: vcbeat) has learned that a novel nasal spray developed by Johnson & Johnson for the treatment of depression has passed the final procedural step required for approval by the U.S. Food and Drug Administration (FDA). It is reported that the FDA will grant final approval for the drug’s clinical use within the next month, marking it as the first new therapeutic approach for depression to be introduced into clinical practice in over 30 years.

The primary active ingredient in this nasal spray is esketamine. Esketamine is a chemical analog of ketamine and shares similar pharmacological properties. Decades ago, ketamine was developed as a novel anesthetic agent. In recent years, numerous scientists have discovered that ketamine exerts unique effects on the brain, producing rapid and significant antidepressant benefits. Following its approval for clinical use in the United States, many patients sought out ketamine—not for its anesthetic properties, but for the treatment of depression.

However, for large pharmaceutical companies, developing ketamine—a decades-old, patent-protected drug—into a treatment for depression is not profitable. Consequently, these companies have begun researching esketamine. Like ketamine, esketamine can alleviate depression; it is approximately twice as potent, is cleared from the body more rapidly, and exhibits fewer negative dissociative symptoms. In most cases, esketamine acts on the brain in a manner similar to ketamine, but it does not affect certain key neural receptors.

Earlier, the FDA granted esketamine two Breakthrough Therapy Designations: one for the treatment of major depressive disorder (MDD) and another for depressive symptoms associated with suicidal ideation or behavior. Among patients with depression, 30% suffer from MDD, a population that has lacked effective treatment options; esketamine offers them significant hope. Furthermore, for patients with depression accompanied by suicide risk, esketamine can rapidly suppress suicidal thoughts—an effect not achievable with other medications.

For years, Johnson & Johnson has been dedicated to researching esketamine nasal spray for the treatment of depression. However, the research process has been fraught with challenges; in two major clinical trials, the company failed to demonstrate that the drug was more effective than a placebo, leading some experts to question its ultimate efficacy. Nevertheless, following the successful FDA approval of esketamine nasal spray, the drug is poised to become Johnson & Johnson’s next blockbuster medication.

A report from Informa Pharma Intelligence (a data analytics group) shows that esketamine is currently the most successful antidepressant. It is projected that by 2024, esketamine alone will generate $2.5 billion in annual revenue in the United States.

(Compiled by Jiao Yanli)