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The U.S. Food and Drug Administration (FDA) has approved a nasal spray with esketamine to help treat depression. The first major depression drug approved by the FDA since Prozac in 1987, the spray is manufactured by Johnson & Johnson under the brand name Spravato. The drug (Spravato) contains esketamine, which is a derivative of ketamine, an anesthesia medicine in the 1960s that has been tested for its use as an antidepressant throughout the years.
This is the first time the FDA has approved esketamine; ketamine, or Ketalar, was officially approved in 1970. Controlled clinical trials studied the safety and efficacy of Spravato in addition to the agency’s drug approval process, which included deep discussions with external advisory committees that ultimately led to the approval of this treatment, according to the FDA.
Spravato is meant to be taken along with antidepressants and is only targeted toward patients who have not responded well to other treatments. "There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, in the agency's statement. "Because of safety concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient."
Of course, there are side effects to using Spravato. The most common side effects experienced by patients treated with the nasal spray in the clinical trials, according to the FDA, were anxiety, lethargy, increased blood pressure, vomiting, feeling drunk, decreased feeling or sensitivity (hypoesthesia), disassociation, dizziness, nausea, sedation, and vertigo.
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Petri Oeschge / Getty
The U.S. Food and Drug Administration (FDA) has approved a nasal spray with esketamine to help treat depression. The first major depression drug approved by the FDA since Prozac in 1987, the spray is manufactured by Johnson & Johnson under the brand name Spravato. The drug (Spravato) contains esketamine, which is a derivative of ketamine, an anesthesia medicine in the 1960s that has been tested for its use as an antidepressant throughout the years.
This is the first time the FDA has approved esketamine; ketamine, or Ketalar, was officially approved in 1970. Controlled clinical trials studied the safety and efficacy of Spravato in addition to the agency’s drug approval process, which included deep discussions with external advisory committees that ultimately led to the approval of this treatment, according to the FDA.
Spravato is meant to be taken along with antidepressants and is only targeted toward patients who have not responded well to other treatments. "There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, in the agency's statement. "Because of safety concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient."
Of course, there are side effects to using Spravato. The most common side effects experienced by patients treated with the nasal spray in the clinical trials, according to the FDA, were anxiety, lethargy, increased blood pressure, vomiting, feeling drunk, decreased feeling or sensitivity (hypoesthesia), disassociation, dizziness, nausea, sedation, and vertigo.
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Continue reading...
