The U.S. Food and Drug Administration (FDA) has approved a nasal spray for the treatment of depression in adults. This announcement was made by the FDA on 5 March 2019.
This new drug is called Esketamine and is manufactured by Janssen Pharmaceuticals Inc. Esketamine is sold under the brand same Spravato and is available for patients who have previously tried other antidepressant medicines but have not benefited from them.
Esketamine is the s-enantiomer of ketamine. Ketamine is a mixture of two enantiomers (mirror image molecules). FDA approved ketamine in the year 1970.
Controlled clinical trials were conducted by the Janssen Company to study and closely evaluate the efficiency, effects, and safety of this drug. The clinical trial consisted of 331 participants in which patients were given medication of esketamine, placebo, and other anti-depressant drugs.
The study consisted of three short term clinical trials and one long term maintaining the effect of the trial. During the clinical trial, participants showed a significant effect on the severity of depression with taking nasal spray as compared to placebo. There were effects witnessed within two days of treatment. However, the other two short term trials did not meet pre-specified statistical tests.
There were certain side effects of people receiving new treatment during the clinical trial. Patients experienced dizziness, nausea, vertigo, decreased feeling or sensitivity, anxiety, vomiting, increased blood pressure and feeling drunk.
As stated by the FDA, for safety reasons, this new drug is only available under a restricted distribution system and will be regulated in a medical office where a health care provider can monitor the patient.
The Spravato contains a warning which cautions the patients that they are at a risk for difficulty with attention, sedation, judgment and thinking, suicidal thoughts and behaviors after intaking the drug.
There are certain precautions that the FDA states the medical offices need to undertake. The FDA also says that the patient should be monitored for two hours after taking the drug and also the drug should not be taken at home. It is also adviced that the patient should not drive for the rest of the day since the intake of the drug.
Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research said, “There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition."
According to the National Institute of Mental Health, about 16 million (approx. 1.6 crores) people in the US suffer from depression. Medication, talk therapy, drugs, etc can help fight depression.
The development of such new treatments to fight against depression is an achievement and necessity for human health.