Icahn School of Medicine Dean Dennis Charney, MD, Co-Invented a Patented Method of Treating Patients with Treatment-Resistant Depression Which Is Part of the Drug Application for Janssen’s Newly Approved SPRAVATO™ (esketamine) CIII Nasal Spray
U.S. Food and Drug Administration Approves New Drug that Could Bring Relief to Millions of People with Treatment-Resistant Depression
Dennis S. Charney, MD, Anne and Joel Ehrenkranz Dean of the Icahn School of Medicine at Mount Sinai, is a co-inventor of a method of treatment for patients suffering from treatment-resistant depression which is patented and part of the drug application for Janssen’s SPRAVATO™(esketmine) CIII nasal spray, which was approved today by the U.S. Food and Drug Administration (FDA). This could bring relief to millions of patients with this condition.
Treatment-resistant depression (TRD) is a devastating disease and has a profound impact on people’s lives. An estimated one-third of people in the United States with major depressive disorder have TRD, which places an ongoing emotional, functional, and economic burden on the individual, their loved ones, and society.1,2,3 TRD is a critical unmet health need associated with greater morbidity, higher health care costs, and various comorbid conditions. In fact, individuals with TRD have been reported to pay more than twice as much in medical costs, were twice as likely to be hospitalized, and had six times higher hospital-related expenditures. 3,4,5
Delivered in the form of a nasal spray, esketamine works differently than the three classes of antidepressants that are currently on the market. The drug works on the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor in the brain. In contrast, widely used antidepressants target different neurotransmitters—serotonin, serotonin and norepinephrine, and norepinephrine and dopamine—and can take weeks or even months to work. These drugs are considered ineffective in at least 30 percent of cases.
“As a researcher, you strive to come up with new treatments for the patient, especially in terms of finding answers to the most debilitating diseases,” said Dr. Charney, who is also President for Academic Affairs, Mount Sinai Health System. “To know that you oversaw the early development of an approach that can make a difference in the lives of countless individuals is extremely rewarding.”
“Dr. Charney is an international expert in neurobiology and the treatment of mood and anxiety disorders, and we commend him and his colleagues for their work in changing the paradigm for patients with treatment-resistant depression,” said Kenneth L. Davis, MD, President and Chief Executive Officer of the Mount Sinai Health System. “Through his commitment to innovation and science, he has inspired countless researchers to leverage new technologies and create new discoveries to benefit the lives of patients around the world—while at the same time leading the Icahn School of Medicine at Mount Sinai to unparalleled growth and high national rankings.”
The new treatment received overwhelming support of an FDA advisory panel on February 12, 2019.
Conflicts of Interest Disclosure: Dr. Charney is named as co-inventor on patents filed by the Icahn School of Medicine at Mount Sinai (ISMMS) relating to the treatment for treatment-resistant depression, suicidal ideation and other disorders. ISMMS has entered into a licensing agreement with Janssen Pharmaceuticals, Inc. and it has and will receive payments from Janssen under the license agreement related to these patents for the treatment of treatment-resistant depression and suicidal ideation under this agreement. Consistent with the ISMMS Faculty Handbook, Dr. Charney is entitled to a portion of the payments received by the ISMMS. Since SPRAVATO has received regulatory approval for treatment-resistant depression, ISMMS and thus, through the ISMMS, Dr. Charney, will be entitled to additional payments, beyond those already received, under the license agreement.
- Rush AJ et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006;163(11):1905-1917.
- Mrazek DA et al. Psychiatr Serv. 2014;65(8):977-987.
- Kubitz N et al. PloS One. 2013;8(10): e76882.
- Corey-Lisle PK et al. J Clin Psychiatry. 2002;63(8):717-26.
- Ivanova JI et al. Curr Med Res Opin. 2010;26(10):2475-84.
About the Mount Sinai Health System
The Mount Sinai Health System is New York City's largest integrated delivery system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai's vision is to produce the safest care, the highest quality, the highest satisfaction, the best access and the best value of any health system in the nation. The Health System includes approximately 7,480 primary and specialty care physicians; 11 joint-venture ambulatory surgery centers; more than 410 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 31 affiliated community health centers. The Icahn School of Medicine is one of three medical schools that have earned distinction by multiple indicators: ranked in the top 20 by U.S. News & World Report's "Best Medical Schools", aligned with a U.S. News & World Report's "Honor Roll" Hospital, No. 12 in the nation for National Institutes of Health funding, and among the top 10 most innovative research institutions as ranked by the journal Nature in its Nature Innovation Index. This reflects a special level of excellence in education, clinical practice, and research. The Mount Sinai Hospital is ranked No. 18 on U.S. News & World Report's "Honor Roll" of top U.S. hospitals; it is one of the nation's top 20 hospitals in Cardiology/Heart Surgery, Gastroenterology/GI Surgery, Geriatrics, Nephrology, and Neurology/Neurosurgery, and in the top 50 in six other specialties in the 2018-2019 "Best Hospitals" issue. Mount Sinai's Kravis Children's Hospital also is ranked nationally in five out of ten pediatric specialties by U.S. News & World Report. The New York Eye and Ear Infirmary of Mount Sinai is ranked 11th nationally for Ophthalmology and 44th for Ear, Nose, and Throat. Mount Sinai Beth Israel, Mount Sinai St. Luke's, Mount Sinai West, and South Nassau Communities Hospital are ranked regionally.