Landmark Health Administers Spravato™ for Depression to First WNY Patient
Tuesday, May 14th, 2019
Buffalo, NY – April 24 – Jarod Masci, M.D., Psychiatrist and President of Landmark Health Systems is the first to administer Spravato™(esketamine) nasal spray to a patient with treatment-resistant depression in Western New York.
Jarod Masci, M.D., President, Landmark Health Systems
The U.S. Food and Drug Administration (FDA) recently approved Spravato™ (esketamine) nasal spray for treatment-resistant depression. Administration of Spravato™ is only available through a restricted distribution system, under the FDA’s Risk Evaluation and Mitigation Strategy (REMS) drug safety program.
It is well known in the mental health community that the likelihood of a patient achieving remission after failing one antidepressant decreases with each subsequent antidepressant trialed.
In drawing from his own experiences, Dr. Masci says, “There is a desperate need for novel therapies for treatment-resistant depression, which can be a serious and life-threatening condition. This is why I am excited to be able to provide Spravato™ to my patients who qualify.”
Although how esketamine exerts its antidepressant effects are unknown, it works differently from typical antidepressants, making it a hopeful new therapy. As is the case with Dr. Masci’s patient, Spravato™ is only approved for patients who have failed at least two antidepressants.
Patients are taught to self-administer Spravato™ under the supervision of a health care provider in a certified doctor’s office or clinic. The medication cannot be taken home. Because of the risk of sedation, dissociation, and increase in blood pressure, patients must be monitored by a health care provider for at least two hours after receiving each dose. Blood pressure must be monitored as indicated throughout the two-hour period. Both prescribers and patients are required to sign a Patient Enrollment Form acknowledging that the patient should not drive or use heavy machinery for the rest of the day that he or she receives the drug.
The most common side effects of Spravato™ are temporary, and typically last only 90 minutes. They include disassociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity (hypoesthesia), anxiety, lethargy, increased blood pressure, vomiting, and feeling drunk. Patients with a history of aneurysmal vascular disease, arteriovenous malformations, intracerebral hemorrhage, or hypersensitivity to esketamine or ketamine should not take Spravato™. The drug may also cause harm to an unborn fetus and should not be taken by women who are breastfeeding.
The FDA granted this application Fast Track and Breakthrough Therapy designations to Janssen Pharmaceuticals, Inc. Spravato™ was evaluated in three short-term (four-week) clinical trials and one longer-term maintenance-of-effect trial. In the short-term studies, patients received either Spravato™ or placebo nasal spray. However, due to the serious nature of treatment-resistant depression and the need for patients to receive treatment, all patients involved received oral antidepressants that were continued throughout the trials. In one of the short-term studies, Spravato™ significantly reducing the severity of depressive symptoms compared to the placebo. Some patients even experienced a positive effect within two days.
Landmark is coordinating the administration of Spravato™ with Parkview Health Services, LLC Pharmacy to administer the drug to their patients.
Jarod Masci, M.D., President of Landmark Health Systems, is board-certified in psychiatry and addiction medicine, and a professor of family medicine at SUNY Jacobs School of Medicine and Biomedical Sciences. Landmark Health Systems is a REMS-certified esketamine treatment center. Learn more about this ground-breaking drug that offers hope to patients who have been unable to find relief from the debilitating and life-threatening effects of depression at https://www.spravato.com.
For a comprehensive informational consultation regarding esketamine treatment by Dr. Jarod Masci, M.D., contact Landmark Health Systems at 716-462-0284 or at 716-465-6818 and visit https://www.jarodmascimd.com. You may also contact Maria Janda, Pharm.D. at 716-462-0284 or at 585-330-9083, or at [email protected].