First Major Depression Drug in Decades Gets FDA Approval

FDA Approves New Ketamine-Related Drug for Treatment of Severe Depression

The United States Food and Drug Administration has approved an esketamine nasal spray by Janssen Pharmaceuticals for treatment of major depression.

Spravato

The drug known as Spravato will be expected to fill a gap created by the ineffectiveness of some currently available treatments in combating major depression. It is the first treatment with a new mechanism of action to be approved by the FDA in about 30 years.

“There has been a longstanding need for additional effective treatments for the treatment-resistant depression, a serious and life-threatening condition,” said Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products at the FDA’s Center for Drug Evaluation Research.

The approval followed evidence of safety and efficacy in separate controlled clinical trials.

Patients who will be qualified for this new drug are those who have used at least two others without any improvement. And they will need to take the esketamine nasal spray together with an oral antidepressant.

An innovative treatment

Spravato is the first revolutionary treatment to be approved for major depression in three decades. It is rapid-acting and works faster than most of the other antidepressants currently available in the American market.

The powerful drug is similar to ketamine. The latter is a potent anesthetic often illegally used as a party drug under the name Special K.

It is reported that existing depression treatments do not help in up to about 40 percent of cases. This is where this new esketamine nasal spray is expected to be useful.

Spravato helps to restore synaptic connections between neurons. In other words, it assists in restoring cells in the brain of people suffering from hard-to-treat depression.

Four clinical trials were reportedly carried out using the drug. Evidence from these studies proved convincing enough for the FDA to grant its approval. Considerably delayed response was reported among patients treated with the nasal spray, in conjunction with an oral antidepressant, in one of the trials that lasted about 16 weeks.

Apart from the clinical studies, Farchione revealed that discussion with FDA’s external advisory committees contributed to the decision to approve the new drug.

Need for caution

The esketamine nasal spray will only be available through a physician. It has to be administered in a certified medical facility to enable proper monitoring of patients by health care providers.

People having treatment-resistant depression can also self-administer the drug, but they will need to do so strictly in a doctor’s office. Patients will not be allowed to take it at home.

The close relationship between this medication and ketamine has raised concerns that people might abuse it the same way they do with ketamine. This lead to the decision of allowing its access only through a restricted distribution system.

Feeling of tiredness, dizziness, nausea, vertigo, reduced sensitivity and anxiety are among possible side effects from using Spravato. The difficulty with attention and dissociation, a temporary feeling of disconnection from mind and body, are also possible.

The drug will carry a Boxed Warning informing of these possible risks. Patients will also be informed about the risk of abuse and misuse as well as suicidal thoughts from the therapy.

Health care providers will be required to monitor their patients for a minimum of two hours after the treatment.

 

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