The Food and Drug Administration has recently approved a nasal spray antidepressant based on the widely used anesthetic, ketamine.
The agency hopes that the new drug will benefit those who find no relief from antidepressants currently available in the market. The newly approved treatment called esketamine is developed by Janssen Pharmaceuticals Inc. It will be sold under the name Spratavo.
“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” stated Tiffany Farchione, acting director of the FDA’s Center for Drug Evaluation and Research – Division of Psychiatry Products.
Esketamine is a departure from Prozac-era of antidepressants. Traditional antidepressants make serotonin, a chemical that contributes to a person’s overall happiness and well-being, available in the brain.
In comparison, esketamine targets a completely different chemical called glutamate. It blocks the glutamate receptor, causing changes in the brain.
In the United States, an estimated 16 million adults live with depression. Of that number, a study found that as many as one-quarter are treatment-resistant.
Moreover, there is excitement surrounding the arrival of esketamine because it acts quick. Patients who take traditional antidepressants do not see relief from their symptoms until after several weeks or even months of taking the medication. Meanwhile, esketamine delivers results within hours or a few days.
The public health agency based the decision to approve esketamine after five Phase 3 trials proved the drug to be safe and effective. Patients who have treatment-resistant depression reported “rapid and sustained improvement” of symptoms.
“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,” added Farchione.
The drug will come with a label warning patients that it has the potential to be abused or misused. To lower the risk, the FDA said that the drug will only be available in certified clinics where medical professionals can monitor patients.
The most common side effects of Spravato include sedation, disassociation, dizziness, nausea, vertigo, lethargy, hypoesthesia or decreased sensitivity, anxiety, increased blood pressure, as well as vomiting.