The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved SPRAVATO™ (esketamine) CIII nasal spray for use in conjunction with an oral antidepressant in adults with treatment-resistant depression (TRD). People who are currently struggling with major depressive disorder (MDD) are 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. It is estimated that approximately one-third of U.S. adults with MDD have TRD. SPRAVATO™ carries a Boxed WARNING regarding a Risk Evaluation and Mitigation Strategy (REMS) and the risk of suicidal thoughts and behaviors in pediatric patients and young adults.
It was hard to have any emotions, because I was just numb. When I began treatment with esketamine and my symptoms started to lift, I could see very clearly just how depressed I had been. I’m now able to appreciate a wider range of emotions than when I was depressed. My long-term goals have taken shape and actually seem attainable,
said Robin P., an esketamine clinical trial patient.
SPRAVATO™ was studied in a robust Phase 3 clinical trial program with more than 1,700 adults with TRD. In a short-term study, those who took SPRAVATO™ and an oral antidepressant experienced superior improvement in depression symptoms at four weeks, compared to those who received a placebo and an oral antidepressant. In a long-term study, patients in stable remission taking SPRAVATO™ who continued treatment with the medicine were 51 percent less likely to relapse versus those who maintained a regimen of a placebo and an oral antidepressant.
In the clinical trials, the most common side effects of SPRAVATO™ when used along with an antidepressant taken by mouth included: dissociation, dizziness, nausea, sedation, spinning sensation, reduced sense of touch and sensation, anxiety, lack of energy, increased blood pressure, vomiting, and feeling drunk.
Depression is a common and potentially debilitating illness that can have profound emotional, functional and economic impact on both those who suffer and their loved ones. The impact of depression is greatest for those who do not benefit from standard treatments. In Phase 3 clinical trials, we saw this therapy provide sustained improvement to patients with treatment-resistant depression,
said Michael E. Thase, M.D., a professor of psychiatry and director of the Mood and Anxiety Disorders Treatment and Research Program in the Perelman School of Medicine at the University of Pennsylvania, who served as a site principal investigator for the clinical trials.
SPRAVATO™ uses the first new mechanism of action in decades to treat MDD. SPRAVATO™ works on the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor in the brain. The medicine is administered as a nasal spray that is absorbed by the lining of the nasal passages and into the blood stream.
SPRAVATO™ has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies. This unique and innovative medicine is a testament to Janssen’s heritage of advancing solutions in neuroscience to heal minds and improve health outcomes,
said Mathai Mammen, M.D., Ph.D.,
Global Head, Janssen Research & Development, LLC.
Once SPRAVATO™ is determined as an appropriate treatment option, in accordance with the REMS, the patient will be treated at a certified treatment center that is trained to administer the medicine and address patient needs. SPRAVATO™ will not be dispensed directly to patients for home use. Instead, SPRAVATO™ will be self-administered by the patient under the direct observation of a healthcare provider. The healthcare provider will then observe the patient for treatment-emergent sedation, dissociation and blood pressure changes for at least two hours, until the patient is safe to leave. Patients should not drive or operate heavy machinery until the next day, following a restful sleep. All patients will be enrolled in the SPRAVATO™ REMS registry to further characterize the risks of serious adverse outcomes from sedation, dissociation, abuse and misuse, and to support safe use of this medicine.
With the approval of SPRAVATO™ comes a new way of treating TRD. Janssen is working quickly to educate and certify treatment centers in accordance with the REMS so healthcare providers can offer SPRAVATO™ to appropriate patients. Later this month, patients can visit www.SPRAVATO.com for a locator tool and to sign up to receive alerts when new treatment centers are available. More locations will be added over time as new treatment centers become certified.
Janssen CarePath offers a comprehensive support program that helps patients get started on SPRAVATO™ and stay on track. 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.