dChan
Anonymous ID: 73563c Feb. 13, 2019, 12:20 p.m. No.5158788   🗄️.is đź”—kun   >>8809 >>8839

Two US Food and Drug Administration (FDA) panels jointly recommended approval of an esketamine 28-mg single-use nasal spray device (Spravato, Janssen Pharmaceuticals) for treatment-resistant depression.

 

The Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management (DSaRM) Advisory Committee together voted that the benefits outweigh the risks for esketamine on the basis of research findings to date and additional risk evaluation and mitigation strategies (REMS) proposed by the FDA.

 

"I think that ultimately, the benefits outweigh the risks, and the thing I'm most concerned about really is diversion and misuse and things like that," said temporary voting member Lee Hoffer, PhD, MPE, associate professor, Department of Anthropology, Case Western Reserve University, Cleveland, Ohio. Hoffer urged close monitoring of the REMS program.

 

The panels voted 14 yes, 2 no (with 1 abstention) in favor of the drug's effectiveness. They voted 15 yes, 2 no (with 0 abstentions) that the company had adequately characterized esketamine's safety profile.

 

Major depressive disorder (MDD) is a serious, chronic, potentially fatal condition. MDD can be debilitating and affects more than 16 million individuals in the United States.

 

First-line treatments for MDD include oral antidepressant medications, including selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, and tricyclic antidepressants, in conjunction with psychotherapy if needed…..

 

https://www.medscape.com/viewarticle/909038?src=soc_tw_190215_mscpedt_news_psych_esketamine&faf=1

Anonymous ID: 73563c Feb. 13, 2019, 12:35 p.m. No.5158916   🗄️.is đź”—kun   >>8922 >>8942

>>5158839

understand

benefits …. it actually works instantly if given for acute suicidality

 

also it works on the unique NMDA receptor which has much to do with signaling opioid receptor remodification and change….. helps alcoholics

 

I am taking LOW DOSESSSS

no psych effects unless abused

drips