A new study published in the New England Journal of Medicine found that Spravato’s esketamine was more effective than a commonly prescribed drug in treating treatment-resistant depression.

Spravato is Johnson & Johnson’s FDA-approved nasal ketamine spray, currently the only approved psychedelic drug on the market. Spravato was compared against Quetiapine, an antipsychotic drug on the market since 2007 (the generic name for Seroquel) often used to boost the effects of antidepressants like SSRIs.

This study looked at 336 adults with treatment-resistant depression who were given Spravato in addition to the antidepressant medication they were already taking (SSRI or SNRI). A separate group of 340 patients used quetiapine with their treatments.

Results: After 8 weeks, the esketamine group showed higher remission rates than the quetiapine group: 27.1% vs. 17.6%. The Spravato group also had better rates of no relapse through 32 weeks: 21.7% vs. 14.1%.

The study also showed that an increasing number of patients continued to reach remission over time: at 32 weeks, 49.1% of patients in the esketamine group and 32.9% of the patients in the quetiapine group were in remission. Hinting that continued treatments could lead to better remission results.

“This large head-to-head trial gives physicians important data to consider in the management of treatment-resistant depression by comparing the short- and long-term effectiveness of SPRAVATO to an oral antipsychotic,” said Reina Benabou, M.D., Ph.D., Vice President, Medical Affairs, Neuroscience, Janssen Scientific Affairs, LLC.

“SPRAVATO offers patients an additional important option. It is critical that those living with this difficult-to-treat condition have choices to consider for their personal treatment plans, in discussion with their healthcare providers.”

This news follows last week’s results of a Small Pharma study, showing that DMT treatments in conjunction with SSRIs increased the efficacy of DMT for depression patients. These kinds of hybrid studies, combining psychedelics with existing SSRI prescriptions, could give patients and doctors more treatment options and increase access for those in need.

See more on the study below.

Large Head-to-Head Study Shows Patients with Treatment-Resistant Depression Receiving SPRAVATO® (esketamine) CIII Nasal Spray Were 1.54 Times as Likely to Reach Remission at 8 Weeks than Patients treated with Quetiapine XR

Study results published in the New England Journal of Medicine give physicians important information on the short- and long-term efficacy of SPRAVATO® in the management of treatment-resistant depression.

TITUSVILLE, N.J., October 04, 2023 – An open-label, international study published today in the New England Journal of Medicine found that patients receiving SPRAVATO® (esketamine) CIII nasal spray for treatment-resistant depression (TRD) were 1.54 times as likely to reach remission after eight weeks than those treated with quetiapine extended-release (XR) at Week 8, (27.1% vs. 17.6%, respectively).1 SPRAVATO®-treated patients were also 1.55 times as likely to stay relapse-free up to 32 weeks after achieving remission at Week 8, without treatment discontinuation, in comparison to those treated with quetiapine XR (21.7% vs. 14.1%, respectively).1

The publication shows for the first time the full breadth of data from ESCAPE-TRD, a randomized, open-label, rater-blinded, active-controlled, ex- U.S. study comparing SPRAVATO® and quetiapine XR, both in conjunction with an oral antidepressant, in adults with TRD.1 SPRAVATO® is indicated along with an oral antidepressant to treat adults with TRD and to treat depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions.2

Adverse events and treatment discontinuation rates observed in the study were consistent with the established safety profile of SPRAVATO® and quetiapine XR treatments.1 Treatment-emergent adverse events occurred in 92% of SPRAVATO®-treated patients compared to 78% of quetiapine XR-treated patients. 4.2% of SPRAVATO®-treated patients and 11% quetiapine XR-treated patients discontinued medication due to an adverse event.1

Key study limitations for the ex- U.S. ESCAPE-TRD trial are its open-label study design, differences in treatment compliance and routes of administration between the groups, and differences in patient touchpoints between the two arms. However, the study design better reflects real-world practice by enabling the sites, all located outside of the U.S., to administer treatment according to their respective prescribing labels.

“This large head-to-head trial gives physicians important data to consider in the management of treatment-resistant depression by comparing the short- and long-term effectiveness of SPRAVATO® to an oral antipsychotic,” said Reina Benabou, M.D., Ph.D., Vice President, Medical Affairs, Neuroscience, Janssen Scientific Affairs, LLC. “SPRAVATO® offers patients an additional important option. It is critical that those living with this difficult-to-treat condition have choices to consider for their personal treatment plans, in discussion with their healthcare providers.”

About Treatment-Resistant Depression
Depression is a common mental disorder that impacts an estimated 280 million people worldwide.3 In the U.S., approximately 21 million adults have had at least one major depressive episode, with an estimated one-third—or 2.8 million—of those living with MDD diagnosed with TRD.4,5 TRD places an ongoing emotional, functional and economic burden on the individual, their loved ones and society.4 TRD has a significant negative impact on the lives of those affected and has one of the highest economic burdens of all psychiatric disorders.4 People living with MDD are often considered to have TRD if they have not responded adequately to at least two different antidepressants of adequate dose and duration in the current depressive episode.4

About ESCAPE-TRD1
Escape-TRD is a randomized, open-label, rater-blinded, active-controlled, international, multicenter phase 3b clinical study designed to evaluate the efficacy, safety and tolerability of flexibly dosed esketamine NS compared with quetiapine XR, both in combination with a continuing selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors in subjects with TRD. Select data from ESCAPE-TRD was previously presented at medical congresses in 2022 and 2023.

The post New Study Shows Spravato Effective When Combined With SSRIs appeared first on Microdose.

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