New Drug Similar To Ketamine Receives FDA Approval To Treat Depression

Alicia Farmer
March 10, 2019

The Food and Drug Administration approved a controversial drug for depression that could be the first of a long-awaited wave of new treatments, but that has also raised concerns about abuse.

Severely depressed patients will have a new, fast-acting treatment option after the USA approved a breakthrough drug that has the potential to upend how the condition is treated.

However, the United States multinational pharmaceutical conglomerate had also placed restrictions over the use of the drug, saying that it could widely by abused and misused.

In order to prevent abuse, FDA had restricted the use of the drug and patients were not allowed to take it at home and they must have to take the drug in a doctor's office or medical facility. The patient will administer Spravato intranasally but only under the supervision of a healthcare provider, who will observe the patient for at least two hours. The patient self-administers Spravato nasal spray under the supervision of a health care provider in a certified doctor's office or clinic, and the spray can not be taken home. Patients will self-administer the nasal spray during visits to a medical clinic, and the spray can not be taken home. During and after each use of the nasal spray device, the health care provider will check the patient and determine when the patient is ready to leave. In the long-term study, patients "who continued treatment with the medicine were 51 percent less likely to relapse versus those who maintained a regimen of a placebo and an oral antidepressant", according to the company's press release.

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The FDA granted the approval of Spravato to Janssen Pharmaceuticals, Inc.

One of the best things about esketamine is that patients see results many times more quickly than in traditional antidepressants like SSRIs, or selective serotonin reuptake inhibitors, which take weeks, if not months, to begin working. The FDA granted the drug both "Fast Track" and "Breakthrough Therapy" designations.

Johnson & Johnson has just been granted FDA approval on a revolutionary new anti-depressant.

The public health agency based the decision to approve esketamine after five Phase 3 trials proved the drug to be safe and effective.

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