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Thread: Ketamine-like Drug Product Fails trial, Is One Step Closer to FDA Approval

  1. #1
    Veteran Member
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    14th July 2010

    Default Ketamine-like Drug Product Fails trial, Is One Step Closer to FDA Approval

    [According to Wikipedia, “Esketamine, sold under the brand names Ketanest among others,[2][3][4][5] is a general anesthetic and a dissociative hallucinogen.[1] It is the S(+) enantiomer of ketamine, which is an anesthetic and dissociative similarly.[1]”]

    J&J's esketamine nasal spray flunks late-stage study in treatment-resistant depression

    Sep. 24, 2018
    Douglas W. House, SA News Editor

    A Phase 3 clinical trial evaluating two dose strengths (56 mg and 84 mg) of Johnson & Johnson (JNJ -0.9%) unit Janssen Pharmaceutical's esketamine nasal spray in patients with treatment-resistant depression failed to demonstrate a statistically valid treatment effect compared to placebo.

    So how did THIS happen?

    FDA Ad Com backs J&J's esketamine nasal spray antidepressant

    Feb. 12, 2019
    Douglas W. House, SA News Editor

    The FDA advisory committees voted 14 - 2 (1 abstain) in favor that Johnson & Johnson's (JNJ +1.5%) Janssen Pharmaceuticals provided sufficient evidence to support the effectiveness of its esketamine nasal spray for treatment-resistant depression.

    Update: The vote was 15 - 2 in favor of the safety profile.
    Update: The vote was 14 - 2 (1 abstain) that the benefits outweigh the risks.

    [Note: Apparently Johnson and Johnson plans to call the nasal spray “Spravato” if it is ultimately approved.]
    Last edited by Islander; 02-14-19 at 11:37 AM.

  2. #2
    Administrator Islander's Avatar
    Join Date
    16th September 2007
    Maine, USA. The way life should be.

    Default Re: Ketamine-like Drug Product Fails trial, Is One Step Closer to FDA Approval

    Wow, Patty, great job of investigative reporting! This is our mission— to uncover evildoing and report it. Well done!
    ā˛¤ Happiness is the frosting on the cake of contentment.

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