The new product is being marketed by American pharmaceutical giant Johnson & Johnson (J&J).
Intended to be used as a fast-acting antidepressant, patients will use the new drug to counteract incidences of major depression alongside suicidal tendencies by inhaling an atomized liquid through the nose, Sputnik previously reported.
"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," Tiffany Farchione, MD, acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said in a March 5 press release.
"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," she added.
"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 nasal spray will be provided to patients with major depressive disorders who have not responded to antidepressant treatments "given at adequate doses for an adequate duration in the current episode," the FDA notes.
According to the press release, the most common side effects experienced by patients who used eskatamine in clinical trials were disassociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity (hypoesthesia), anxiety, lethargy, increased blood pressure, vomiting and feeling drunk.
"Our comprehensive research program for esketamine nasal spray supports a positive benefit-risk profile for adults with treatment-resistant depression," said Husseini Manji of Janssen Research & Development — a J&J branch — in February.