Tag: esketamine

A Win for Science, with Profound Implications for Industry: FDA Rejects...

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Concerns, from functional unblinding to sexual assault in the clinical trials, led this week to a full repudiation of Lykos' MDMA-assisted therapy.

The Spravato Controversy: A Row Over the Drugā€™s Efficacy Compels...

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The UK's drug regulator rejected Janssen's esketamine nasal spray. Why did the US FDA approve it?

Lithium, Antidepressants, Esketamineā€”All No Better Than Placebo?

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Peter Simons covers a clinical trial that found lithium ineffective at preventing suicide attempts, an essay by Allen Frances on the overdiagnosis of depression and overprescription of antidepressants, a review of the ineffectiveness and dangers of antidepressants, and an analysis that revealed that esketamine failed five of its six clinical trials.

Psychedelicsā€”The New Psychiatric Craze

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Psychedelics have become popular through the potent mixture of financial interests and desperation. Evidence for their beneficial effects is lacking.

New Research Questions Safety of Esketamine for Depression

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An analysis of FDA adverse event reports related to esketamine shows the potential for negative effects such as suicidal and self-injurious ideation.

John Read ā€“ UK Esketamine Approval – Not so Fast

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An interview with Professor John Read who joins us to discuss the UK licensing of esketamine nasal spray (Spravato) for so-called ā€˜Treatment Resistant Depressionā€™. John led a group of 12 academics and professionals who wrote to the UK regulator expressing concerns.

Are Regulatory Bodies Prioritising Drug Company Interests Over Public Safety?

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The UKā€™s Medicines & Healthcare Products Regulatory Agency is refusing to respond to the concerns of psychiatrists, parliamentarians, patients and other experts about the impending licensing of the street drug ketamine as a treatment for depression.

ā€œFlimsy Evidenceā€ for Esketamine as Depression Treatment

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A new article documents the ā€œflimsy evidenceā€ behind the recent FDA approval of the party drug esketamine for the treatment of depression.

Nasal Spray for Depression? Not So Fast

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Several members of the FDA Advisory Committee perceived this new drug as a potential ā€œgame changerā€ in the way depression is treated. I, however, am NOT one of them. I take my role as the Consumer Representative very seriously and want to make sure that any pharmaceutical drug that the FDA approves shows greater benefit than potential harm.