Jun 20, 2019 | Updated: 09:31 AM EDT

FDA approves a nasal spray as a new antidepressant drug

Mar 09, 2019 11:11 AM EST

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Esketamine, made by Janssen Pharmaceuticals, was approved by the Food and Drug Administration this week for those who get little to no relief from at least two different usual antidepressants prescribed by doctors. This nasal spray drug will be marketed under the name Spravato, and it is the first drug for depression made from ketamine, a widely used aesthetic for years.

The recommended dosage for Spravato is twice a week for four consecutive weeks, and it should be taken together with the traditional oral antidepressants. This nasal spray is fast-acting, unlike the antidepressants that are taken orally that takes weeks to work, so it can help those patients who are constantly having suicidal thoughts.

The user needs to squirt the spray into their nostril, and the lining of the nasal passages will absorb the esketamine which will enter the bloodstream. The esketamine acts on the N-methyl-D-aspartate receptor found in the brain.

However, there is a risk of side effects and a potential for abuse and misuse of the product. The FDA has declared strict monitoring and distribution of the said drug.

"Because of safety concerns," says Dr. Tiffany Farchione, a health expert who works in the FDA's Center for Drug Evaluation and Research, "the drug will only be available through a restricted distribution system, and it must be administered in a certified medical office where the healthcare provider can monitor the patient."

Esketamine and ketamine have side effects including hallucinations and out-of-body sensations. This drug must be taken under the supervision of a doctor in a clinic or a doctor's office. The patients must be monitored for two hours after taking the drug, and their experience must be entered in a registry, and the patient must not do any physical activity on the day of the treatment, such as driving.

"People have to come in twice a week to the hospital and stick around for two hours being monitored. So, you've got to have space for them, and the question is, where? The waiting room's not going to work - in the clinic somewhere, which can be hard to find. And then someone's got to drive them home." said Dr. Erick Turner, a psychiatrist at Oregon Health & Science University.

The cost is another issue with Spravato, as the wholesale price for the initial treatment for a month will range from $4,720 to $6,785. Although insurers are likely to cover at least a portion of the cost of Spravato, the industry does not solely rely on the lead of the government.

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