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



Pattypans
02-24-19, 03:29 PM
[According to Wikipedia, “Esketamine, sold under the brand names Ketanest among others,[2] (https://en.wikipedia.org/wiki/Esketamine#cite_note-MDS-2)[3] (https://en.wikipedia.org/wiki/Esketamine#cite_note-3)[4] (https://en.wikipedia.org/wiki/Esketamine#cite_note-4)[5] (https://en.wikipedia.org/wiki/Esketamine#cite_note-5) is a general anesthetic (https://en.wikipedia.org/wiki/General_anesthetic) and a dissociative (https://en.wikipedia.org/wiki/Dissociative) hallucinogen (https://en.wikipedia.org/wiki/Hallucinogen).[1] (https://en.wikipedia.org/wiki/Esketamine#cite_note-HimmelseherPfenninger2008-1) It is the S(+) enantiomer (https://en.wikipedia.org/wiki/Enantiomer) of ketamine (https://en.wikipedia.org/wiki/Ketamine), which is an anesthetic and dissociative similarly.[1] (https://en.wikipedia.org/wiki/Esketamine#cite_note-HimmelseherPfenninger2008-1)”]

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 (https://seekingalpha.com/symbol/JNJ) -0.9%) unit Janssen Pharmaceutical's esketamine nasal spray in patients with treatment-resistant depression failed to demonstrate (https://seekingalpha.com/pr/17277626-janssen-announces-results-esketamine-nasal-spray-phase-3-study-patients-treatment-resistant) a statistically valid treatment effect compared to placebo.

https://seekingalpha.com/news/3392427-j-and-js-esketamine-nasal-spray-flunks-late-stage-study-treatment-resistant-depression
(https://seekingalpha.com/news/3392427-j-and-js-esketamine-nasal-spray-flunks-late-stage-study-treatment-resistant-depression)
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.

https://seekingalpha.com/news/343230...antidepressant (https://seekingalpha.com/news/3432305-fda-ad-com-backs-j-and-js-esketamine-nasal-spray-antidepressant)

[Note: Apparently Johnson and Johnson plans to call the nasal spray “Spravato” if it is ultimately approved.]

Islander
03-07-19, 10:18 AM
Did anyone notice that yesterday's media all broke the same story, in excited tones, with barely contained enthusiasm? There was just one little problem: every one of the MSM claimed that the FDA has approved this miracle drug for depression… Except for the New York Times, which specifically said, "The cost for these treatments typically is out of pocket, as the generic anesthetic is not approved by the F.D.A. for depression." See for yourself: https://www.nytimes.com/2019/03/05/health/depression-treatment-ketamine-fda.html

Pattypans
03-09-19, 07:19 AM
The NYT also says that the FDA has approved Janssen's new drug: "On Tuesday, the Food and Drug Administration approved a prescription treatment intended to help them, a fast-acting drug derived from an old and widely used anesthetic, ketamine."

The treatment referred to in the sentence you cited is generic ketamine, which is an anesthetic, when it is used for depression:

"The cost for these treatments [this refers NOT to esketamine and this new product, but to ketamine itself, which is a generic anesthetic also used for depression in some clinics, as explained in the previous paragraph] typically is out of pocket, as the generic anesthetic is not approved by the F.D.A. for depression. In contrast, esketamine likely would be covered under many insurance plans, and its side effects, though similar to those of generic ketamine, are thought to be less dramatic."

It might have been clearer if the author had used “those” treatments instead of “this,” or perhaps just worded it differently.

Pattypans
03-09-19, 07:21 AM
Also important to note, I think, is this, from the same NYT article:

"Historically, the F.D.A. has required that a drug succeed in two short-term trials before it is approved; the agency loosened its criteria for esketamine, opting instead to study relapse in people who did well on the drug." (Emphasis added)

Islander
03-09-19, 10:37 AM
Well that explains your earlier question about how, despite the drug's failure to demonstrate reliable effects, its approval was moved forward anyway. Well, that plus dollars. Janssen will make bank on the staggering cost of the treatment — which is based on a cheap black-market club drug!