FDA allows treatment of depression with club drug's cousin

FDA allows treatment of depression with club drug's cousin

Spravato is a nasal spray from Johnson & Johnson that's a close cousin of ketamine, an anesthetic that's sometimes used recreationally and often known as "Special K".

On Tuesday, the 5th of March 2019, the US Food and Drug Administration had issued a statement saying that they had approved a nasal spray antidepressant of Johnson & Johnson for the people resistant to other treatments such as conventional anti-depressants and low-dose benzodiazepines.

"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition", said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. According to the expert and as reported by Rolling Stone, The approval has been granted by the agency after several successful clinical trials on the effectiveness and safety of the drug, and also after it passed their careful review.

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.

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The agency hopes that the new drug will benefit those who find no relief from antidepressants now available in the market.

Although it was approved, the new medication has many risks and is therefore required to be used only under the direct supervision of a physician. 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. During and after each use of the device, the health care provider will check the patient and determine when the patient is ready to leave.

In four studies that led to its approval, Spravato performed well against placebo, the FDA said, showing a "statistically significant effect compared to placebo on the severity of depression, and some effect was seen within two days". Side effects may include sedation and dissociation, and as such patients are required to stay with a professional caretaker for two hours after taking the medication.

The FDA granted this application Fast Track and Breakthrough Therapy designations.