FDA approves use of ketamine-like drug to treat depression

The Food and Drug Administration (FDA) has approved a ketamine-like nasal spray drug to help drug-resistant depression. 

Spravato is made from a chemical called esketamine, which is similar to ketamine, a popular club drug. This is the FDA’s first approved use of esketamine.

{mosads}”There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” said Tiffany Farchione, the FDA’s acting director of psychiatry products, in a Tuesday news release. 

Spravato will not be given directly to patients for home use, according to a pharmaceutical spokesperson. Instead, patients will use it under the observation of a health care provider. 

The FDA approved the spray in conjunction with an oral antidepressant through a restricted distribution system due to the potential for adverse outcomes and misuse. 

Common side effects of Spravato found in clinical trials apparently included disassociation, dizziness, nausea, sedation, anxiety, vomiting and feeling drunk.

Spravato will be sold by Johnson & Johnson’s Janssen Pharmaceutical Companies. A company spokesperson said that during the drug’s one-month induction phase, its wholesale acquisition cost ranges from $4,720 to $6,785 and then $2,360 to $3,540 monthly, not including administration and observation costs.

“Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process … were important to our decision to approve this treatment,” Farchione said. 

Patients who have adequately tried two antidepressants to treat their major depressive disorder are considered to have treatment resistant depression. 

“SPRAVATO has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies,” said Mathai Mammen, the global head of Janssen Research & Development.