United States approves ketamine-like drug for depression

Leslie Hanson
March 8, 2019

It also has a compound similar to Ketamine, which is often abused as a party drug known as "special-k".

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".

Janssen said the FDA relied on five studies showing the nasal spray worked more quickly than many now marketed anti-depressants, which sometimes take several weeks to have an effect.

Janssen Pharmaceutical, a division of Johnson & Johnson that developed the drug, said the new medication will be used in conjunction with an oral antidepressant in adults with treatment-resistant depression.

"Because of [safety] concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient", Farchione said.

Greg Panico, a spokesman for Janssen, a division of Johnson & Johnson, did not say when Spravato will be available.

However, the panel members echoed concerns raised by FDA staffers regarding the increased risk of sedation, dissociation and higher blood pressure observed in the study.

The FDA recommended implementing a risk evaluation and mitigation strategy (REMS) program which included making sure esketamine is only dispensed and administered under medical supervision. That speed of onset has won it a pair of breakthrough designations from the FDA, one in treatment-resistant depression and the other for MDD with an imminent risk of suicide. 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.

It's been a rocky road to approval though - two of the five large trials used to support the drug's filing failed to reach their efficacy endpoints, and while this is not uncommon for depression drugs FDA reviewers were also concerned about the safety issues associated with ketamine. 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.

The UN agency said each year almost 800,000 people die by suicide, which is the second leading cause of death among 15-29 year olds worldwide. Individuals with depression, including major depressive disorder, suffer from a serious, biologically based disease that has a significant negative impact on all aspects of life, including quality of life and function.

It works by restoring brain cells in patients with treatment-resistant depression.

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