Spravato Nasal Spray can be prescribed at general hospitals

It passed DC of Kyunghee University Hospital and Chung-Ang University Hospital, including Big5 such as SMC and SNUH

Addition of indications related to suicidal impulse

Janssen's new depression drug Spravato can be prescribed at general hospitals.

 

According to related industries, in addition to Big5 such as SMC and SNUH, Kyunghee University Hospital, Kyungpook National University Hospital, Pusan ​​Paik Hospital, Chung-Ang University Hospital, Jeju National University Hospital, and Haeundae Paik Hospital have passed DC of Spravato (Esketamine), which is used as a combination therapy with oral antidepressants.

 

Spravato, approved in Korea in June last year, is the first Nasal Spray in the field of treatment-resistant depression and the first in 30 years in the field of major depressive disorders.

 

Spravato (Esketamine) improves symptoms of depression by regulating the activity of glutamic acid receptors called NMDA receptors in the brain, thereby restoring synaptic connections and increasing neurotrophic signaling.

 

Spravato also added indications for a major depressive disorder with suicidal thoughts at the end of last year.

 

Baek Jong-woo, a professor of mental health medicine at Kyunghee University Hospital, said, “In a serious situation with the highest suicide rate among OECD countries, we are excited to receive approval for a new and rapid treatment method for major depressive disorders with suicidal thoughts and behaviors.

 

In the future, medical treatment will be applied through insurance coverage, etc.

 

" "We look forward to having the system in place quickly so that people in real crisis in the field can use it when they need it." Spravato's indications for suicidal depression were based on the results of the ASPIRE I study and the ASPIRE II study, a global phase 3 clinical trial.

 

In both ASPIRE I and ASPIRE II studies, Spravato was used in combination with conventional standard therapy (including oral antidepressants and hospitalization) as a primary efficacy defined as reduction of depressive symptoms within 24 hours after first dose on the Montgomery-Asberg Depression Rating Scale (MADRS).

 

The endpoints were met.

 

The efficacy in treatment-resistant depression, the first approved indication, was demonstrated in a phase 3 clinical trial consisting of short-term and long-term trials in more than 1,700 adult patients.

 

the efficacy of Spravato in a short- and long-term phase 3 clinical trial conducted on 1,700 patients with treatment-resistant depression.

 

Short-term clinical trial TRD (Treatment-Resistant Depression) 3002 divided 223 patients with treatment-resistant depression aged 18 to 65 years of age, and administered either Spravato and oral antidepressant group or placebo and oral antidepressant group.

 

The results showed that the effect of improving treatment-resistant depression was excellent in the Spravato group compared to the placebo group.

 

Particularly, the Montgomery-Asberg Depression Rating Scale (MADRS) score was significantly lowered (19.8 points vs.

 

15.8 points).

 

In the long-term trial, the recurrence probability in the Spravato group was also 51% lower than that of the placebo group.