Janssen gets FDA nod for Spravato
The Food and Drug Administration has greenlighted Janssen Pharmaceutical’s Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression).
"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," acting director of the division of psychiatry products in the FDA's Center for Drug Evaluation and Research Tiffany Farchione said. "Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA's drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment. 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."
The patient self-administers Spravato nasal spray under the supervision of a health care provider in a certified doctor's office or clinic, and the spray cannot be taken home. The health care provider will instruct the patient on how to operate the nasal spray device. During and after each use of the nasal spray device, the health care provider will check the patient and determine when the patient is ready to leave.
Esketamine is the s-enantiomer of ketamine. Ketamine is a mixture of two enantiomers (mirror image molecules). This is the first FDA approval of esketamine for any use; the FDA approved ketamine (Ketalar) in 1970.
The FDA granted Spravato Fast Track and Breakthrough Therapy designations.
"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," acting director of the division of psychiatry products in the FDA's Center for Drug Evaluation and Research Tiffany Farchione said. "Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA's drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment. 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."
The patient self-administers Spravato nasal spray under the supervision of a health care provider in a certified doctor's office or clinic, and the spray cannot be taken home. The health care provider will instruct the patient on how to operate the nasal spray device. During and after each use of the nasal spray device, the health care provider will check the patient and determine when the patient is ready to leave.
Esketamine is the s-enantiomer of ketamine. Ketamine is a mixture of two enantiomers (mirror image molecules). This is the first FDA approval of esketamine for any use; the FDA approved ketamine (Ketalar) in 1970.
The FDA granted Spravato Fast Track and Breakthrough Therapy designations.