TITUSVILLE - The Janssen Pharmaceutical Companies of
SPRAVATO is the first and only approved medicine that has been shown to reduce depressive symptoms within 24 hours,1 providing a new option for significant symptom relief until a longer-term, comprehensive treatment plan can take effect.
The effectiveness of SPRAVATO in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of SPRAVATO does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO. SPRAVATO carries a Boxed Warning regarding a Risk Evaluation and Mitigation Strategy (REMS) and the risk of suicidal thoughts and behaviors. Janssen is working to responsibly educate and certify treatment centers in accordance with the REMS so healthcare providers can offer SPRAVATO to appropriate patients.
Depression is the leading cause of disability worldwide and the condition most frequently associated with suicide.2 MDD is a serious disease that causes a significant, negative impact on the way people think, feel and act.3 Symptoms and severity vary by person and may include persistent feelings of sadness, hopelessness or tension; changes in sleep or appetite; difficulty concentrating or performing activities of daily living; lack of interest and/or thoughts of harming themselves.3
'Many people who live with depression know all too well the feeling of desperation. If that major depression progresses to active suicidal thoughts, it's crushing, and they need options to help change the trajectory of their acute depressive episode,' said
The sNDA approval is based on two identical Phase 3 clinical trials in which SPRAVATO plus comprehensive standard of care demonstrated a significant, rapid reduction of depressive symptoms within 24 hours, with some patients starting to respond as early as four hours. SPRAVATO plus comprehensive standard of care led to a 15.9 and 16.0 point decrease on the Montgomery-Asberg Depression Rating Scale (MADRS), a tool used to assess severity of depressive symptoms, in the two trials at 24 hours after the first dose of study medication. This compared to a reduction of 12.0 and 12.2 points in the placebo plus comprehensive standard of care group. The comprehensive standard of care included initial hospitalization, a newly initiated or optimized oral antidepressant and twice-weekly treatment visits for four weeks, during which patients received SPRAVATO 84 mg or placebo nasal spray.4,5
Both the SPRAVATO and placebo groups continued to improve between four hours and 25 days, with 41 percent and 43 percent of the SPRAVATO plus comprehensive standard of care group achieving clinical remission of depression (minimal or no symptoms) compared with 34 percent and 27 percent in the placebo groups, by the end of the double-blind period, in the two trials, respectively.4,5
'It is astonishing to me that despite what we know about the risk of serious suicidal ideation in the context of major depression, patients with suicidal ideation have previously been excluded from nearly all studies examining antidepressant treatment efficacy. There is an immense need for high quality evidence showing effective and rapid antidepressant action in this population,' said
In the two Phase 3 trials, improvement in the severity of suicidality at 24 hours was measured using a standardized global scale. The treatment difference between the two groups was not statistically significant on this key secondary endpoint. Both SPRAVATO and placebo in combination with comprehensive standard of care showed a similar reduction on this measure.4,5
The safety profile observed in the trials was consistent with previous studies of SPRAVATO in treatment-resistant depression (TRD), adding to the established body of safety and efficacy evidence. The most common side effects included dissociation (feeling disconnected from yourself, your thoughts, feelings, space and time), dizziness, sedation (sleepiness), increased blood pressure, hypoesthesia, vomiting, euphoric mood and vertigo.1
With this new indication, SPRAVATO can be prescribed to treat depressive symptoms in two MDD subpopulations of adults with high unmet need: TRD, which the FDA approved on
A full course of treatment for the new indication is twice weekly for four weeks, after which evidence of therapeutic benefit should be evaluated to determine need for continued treatment. Please click here for the full Prescribing Information.
'People living with major depression need more options to meet their most critical needs, and we're proud to help redefine how we treat ongoing and acutely worsening depressive symptoms,' said
Once SPRAVATO is determined as an appropriate treatment option, in accordance with the REMS, patients will be treated at a certified treatment center trained to administer the medicine and address their needs. Janssen will educate healthcare providers and payers on this updated label to ensure appropriate patients are evaluated and the full course of treatment is delivered in a safe, appropriate and controlled manner for patients to receive the maximum treatment benefit.
For patients who need help getting started on SPRAVATO and staying on track, Janssen CarePath offers a comprehensive support program. Janssen CarePath provides information on insurance coverage, potential out-of-pocket costs and treatment support, and identifies options that may help make treatment more affordable, including the Janssen CarePath Savings Program for commercially insured patients who are eligible.
About SPRAVATO
SPRAVATO (esketamine) CIII nasal spray is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor - an ionotropic glutamate receptor. It has a novel mechanism of action, meaning it works differently than currently available therapies for major depressive disorder (MDD).
SPRAVATO is approved in
About the SPRAVATO Risk Evaluation & Mitigation Strategy (REMS)
A REMS program is in place to ensure the safety of all patients who are treated with SPRAVATO. SPRAVATO is available only through a restricted distribution program called the SPRAVATO REMS. The goals of the REMS are to mitigate the risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO administration, and abuse and misuse of SPRAVATO, by: Ensuring SPRAVATO is only dispensed and administered to patients in medically supervised healthcare settings that monitor these patients
Ensuring pharmacies and healthcare settings that dispense SPRAVATO are REMS certified
Ensuring each patient is informed about serious adverse outcomes from dissociation and sedation and the need for monitoring
Enrolling all patients who receive treatment in an outpatient healthcare setting in a REMS registry to further characterize the risks and support safe use
About the Phase 3 Studies4,5
ASPIRE I and ASPIRE II evaluated the efficacy and safety of SPRAVATO in addition to a comprehensive standard of care in adult patients with major depressive disorder who had active suicidal ideation with intent. This is the first global clinical program to study this severely ill patient population, who have been typically excluded from antidepressant clinical trials, addressing a great unmet need. Patients were defined as those with major depression and active suicidal thoughts with intent. Every patient was treated with a comprehensive standard of care in both trials to safely and ethically conduct the studies. The comprehensive standard of care included initial hospitalization, a newly initiated or optimized oral antidepressant and twice-weekly treatment visits for four weeks.
The primary efficacy endpoint of the double-blind, randomized, placebo-controlled, multicenter studies was a reduction in depressive symptoms at 24 hours after the first dose, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). The MADRS scale is a tool used to assess severity of depressive symptoms, allowing clinicians to evaluate 10 symptoms on a six-point scale to produce a total score of up to 60 points. A secondary efficacy endpoint measured improvement in severity of suicidality as measured by the revised Clinical Global Impression of Severity of Suicidality (CGI-SS-r), a seven-point scale developed by clinical experts that is a measure of the severity of suicidality as judged by the clinician's global impression.
About the Janssen Pharmaceutical Companies of
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