Advocates cheer FDA approval of anti-depressant nasal spray

Ketamine-based drug approved for treating severe depression in the US

The drug brand named Spravato contains Esketamine as is manufactured by Janssen (14-2 in favour of the drug). That means patients who have not responded to "at least two antidepressant treatments given at adequate doses for an adequate duration in the current episode", according to the FDA.

Esketamine, a chemical cousin of the anesthetic and party drug ketamine, represents the first truly new kind of depression drug since Prozac hit the market in 1988.

Prozac therapy can take weeks or months to become effective, but Spravato has an nearly immediate effect as it alters the neurotransmitter glutamate, according to researchers.

Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research said in s statement, "There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition".

A mind-altering medication related to the club drug Special K won USA approval Tuesday for patients with hard-to-treat depression, the first in a series of long-overlooked substances being reconsidered for severe forms of mental illness. A short-term study showed that those who took the drug and an oral antidepressant demonstrated a reduction in depression symptoms at four weeks when compared to those that received a placebo and an oral antidepressant.

Since enrolling in a Spravato trial two years ago, Prothro says her depression has lifted and she's returned to hobbies she abandoned years ago, like gardening.

Esketamine has the potential to be a game-changer in treating depression, said Walter Dunn, MD, PhD, of the University of California Los Angeles, and a member of the FDA's Psychopharmacologic Drugs Advisory Committee. First, the antidepressant will only be available at a physician's office or clinic.

A new drug has just been approved to help those battling depression who haven't had success with other treatments. The REMS program also provides for monitoring of Spravato's side effects.

The FDA is requiring patients who are prescribed the drug to be monitored closely, due to the possibility of negative reactions of sedation and disassociation tied to the drug. But the FDA approval, he adds, is a step toward having another viable and safe treatment for major depression.

A decades-old drug, ketamine is already used off-label to treat depression by some doctors. During the first month, a patient will have two sessions per week ranging between US$5,000 and US$5,000. He said the approval legitimizes the approach he and other doctors have been taking.

The list price of a drug is not necessarily what patients actually pay.

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