Janssen's Spravato (Esketamine Nasal Spray) Launches in China as First Rapid-Acting Antidepressant for Adults with Major Depressive Disorder and Acute Suicidal Ideation or Behavior

China Finance and Economics News, March 7th: Johnson & Johnson announced today that its antidepressant drug Spravato (Esketamine Hydrochloride Nasal Spray) has been officially launched in China.

Zynlonta is the first approved antidepressant for use in combination with oral antidepressants to alleviate depressive symptoms in adult patients with major depressive disorder accompanied by acute suicidal ideation or behavior, featuring a novel mechanism of action and route of administration.

Data shows that in China, major depressive disorder (MDD) and its potential risk of suicide are constantly pressing on patients and their families. According to the China Mental Health Survey, the weighted lifetime prevalence of major depressive disorder among adults in China is 3.4%. As one of the most common mental illnesses, major depressive disorder is mainly characterized by significant and persistent low mood, affecting various core aspects of a patient’s life such as diet, sleep, self-worth, and decision-making ability. Suicidal ideation or behavior is one of the main symptoms of depression and also a severe consequence. Studies suggest that the lifetime prevalence rates of suicidal ideation and attempted suicide among Chinese patients with depression are 53.1% and 23.7%, respectively.

Compared with ordinary depression patients, depression patients with suicidal symptoms often have more severe symptoms, more frequent psychiatric comorbidities, and a heavier disease burden, requiring more rapid and effective timely intervention. However, most existing antidepressant drugs require four weeks to take full effect, so there is an urgent need for treatment options that can quickly alleviate depressive symptoms.

Peter Fang, Global Vice President of Johnson & Johnson Innovative Pharmaceuticals and Head of Neuroscience

Unlike existing antidepressants that mostly act on the monoamine pathway, Spravato exerts its antidepressant effect by antagonizing the N-methyl-D-aspartate (NMDA) receptor and is administered via nasal spray. Clinical studies have shown that Spravato, when combined with oral antidepressants, can rapidly alleviate depressive symptoms in adult patients with acute suicidal ideation or behavior. Johnson & Johnson announced today that its antidepressant medication, Spravato (esketamine hydrochloride nasal spray), has officially launched in China.

Cherry Huang, President of Johnson & Johnson Innovative Pharmaceuticals, China

Results from two pivotal global Phase III clinical trials, ASPIRE I and ASPIRE II, demonstrated that in adult patients with depression accompanied by acute suicidal ideation or behavior, those receiving Spravato (esketamine) in conjunction with standard care experienced a significant reduction in depressive symptoms within 24 hours compared to the placebo group, with this effect evident as early as within 4 hours. Additionally, during the double-blind treatment period, a higher proportion of patients treated with Spravato achieved remission of depressive symptoms at all time points compared to the placebo group. 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 them.

Liu Guangyuan, Head of Medical Affairs at Johnson & Johnson Innovative Pharmaceuticals

Safety evaluations indicate that most adverse events associated with Suvorexant are mild or moderate and resolve on the day of administration. Regarding its use, Suvorexant is restricted to administration within medical institutions and must be given under the direct supervision of healthcare professionals. Patients must be observed and monitored after administration.

The above data indicates that for patients with depression who have acute suicidal ideation or behavior, the launch of Spravato in China will effectively meet their urgent need for rapid relief of depressive symptoms, thereby providing patients with a new treatment option.

Professor Pan Chengying (second from the left) from the Sixth Hospital of Peking University, Wang Jianyi (third from the left), EAP contracted counselor at the Chinese Academy of Sciences Psychology Institute, and He Xuzheng (fourth from the left), Head of Neuroscience and Pulmonary Arterial Hypertension Products Division, Innovative Pharmaceuticals China, Johnson & Johnson

Since the launch of the first product for treating mental illnesses in 1997, Johnson & Johnson Innovative Pharmaceuticals has continuously provided various innovative treatment solutions for patients with mental disorders in China, relying on its expertise in the mental health field and through ongoing research and significant investment. Cherry Huang, President of Johnson & Johnson Innovative Pharmaceuticals, China, stated: "We are very pleased to see that Spravato brings new hope to patients shrouded in the shadow of depression. In the future, we will remain committed to our promise and continue to work closely with relevant institutions to improve drug accessibility and benefit patients in China."