FDA has approved a new drug to treat severe depression

Spravato

Spravato

A longer-term evaluation, meanwhile, demonstrated stable remission in patients who continued with Spravato, plus an oral antidepressant.

"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.

USA health officials have approved a medication related to the mind-altering drug ketamine as a new option for patients with severe depression. It may also be self-administered but only under the supervision of a care provider and can not be taken home. To prevent abuse, patients must take the drug in a doctor's office or medical facility and can not take it home.

Esketamine is a glutamate NMDA receptor modulator, and is of particular interest to clinicians because it starts to work much more quickly than current antidepressants.

Pierre de Maricourt of the Sainte-Anne Hospital in Paris, participating in two phase 3 trials for the drug, hailed the approval as "major evolution in the treatment of depression". These included increased risk of sedation, dissociation and higher blood pressure.

The drug, designed for those who have tried at least two other medications, offers "a potential therapy for adults living with treatment-resistant depression", the company said, including help in combating suicidal thoughts.

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"Depression is a common and potentially debilitating illness that can have profound emotional, functional and economic impact on both those who suffer and their loved ones", said University of Pennsylvania Dr. Michael E. Thase, a principal investigator for the drug's clinical trials.

Ketamine has always been seen as a potential breakthrough in depression treatment, despite safety concerns arising from the fact that the anesthetic is commonly abused as a recreational drug.

In clinical trials, six patients who were taking the drug died, three from suicide, but FDA background materials reviewed by the advisory committee that recommended approval last monthsaid, "It is hard to consider these deaths as drug-related".

Concerns have also been raised about a lack of long-term data on possible health effects, most notably cognitive ones. That classification is meant to expedite the development and review of drugs to treat a serious condition, and preliminary clinical evidence indicates the drug may show substantial improvement over available treatments.

Greg Panico, a spokesman for Janssen, a division of Johnson & Johnson, did not say when Spravato will be available. J&J has said the wholesale acquisition cost of the drug will be between $590 and $885, depending on the dose, which will put a treatment course at between roughly $5,000 to $7,000.

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