Newest Psychiatric Treatments for Generalized Anxiety Disorder (GAD)

Newest Psychiatric Treatments for Generalized Anxiety Disorder (GAD)

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There are few drugs that are Food and Drug Administration (FDA) indicated first line for Generalized Anxiety Disorder (GAD).  Selective Serotonin Inhibitors (SSRIs) such as Lexapro (escitalopram), approved in 2005, and Paxil (paroxetine), approved in 1999, by the FDA.  Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) venlafaxine, FDA approved in 1999, and duloxetine, FDA approved in 2007. However, neither drug was designed for GAD.  These four drugs are FDA, first line indicated, for GAD.  First line indicated means just that first line.  The first drugs you reach for when prescribing for a medical condition.  However, they were not designed for GAD.  GAD was considered and approved, by the FDA, since they had good tolerability and later were proven to treat GAD.  

However, there is a first line, designed drug, for GAD in the making.  CYB004.  Yes, it sounds like something of a great secret code.  Drugs are given numbers as designations before ever given a name.  It is a deuterated form of N,N-dimethyltryptamine (DMT), often called deuterated DMT (dDMT). It’s a novel chemical entity being developed by Cybin Inc.   Its actual targe indication is GAD.  

It finished up its second phase clinical trial.  Meaning it is still undergoing studies, for about a year, until it gets to be considered by the FDA for an actual approved treatment for GAD.   That is if Cybin company decides to pay the $900,000 application fee so the FDA will look at the molecule and studies.  The Phase 2 study (“CYB004-002”) is randomized, double-blind, ~36 participants with moderate-to-severe GAD (GAD-7 score ≥ 10). It includes people already on antidepressants or anxiolytics and allows comorbid depression

Currently CYB004, has recently been approved by the FDA for its third clinical trials.  Why this drug caught this authors attention is due to its fast effects.  It is currently Dosed scheme: two intramuscular injections (20 mg predicted therapeutic dose vs 2 mg sub-therapeutic control) given 3 weeks apart.  There is an intranasal delivery also being worked on, like Flonase.  

When you choose to make South Chesapeake Psychiatry your Psychiatric Clinic, this is the type of care to expect:  First line treatments.  We are always educating ourselves and others to make sure that the best and most up-to-date treatments are being utilized for our patients for the best psychiatric practices.

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