“In primary care settings benzodiazepines are frequently prescribed for psychiatric symptoms, despite their adverse event profile and their potential risk for dependence. The non-benzodiazepine drug etifoxine is a promising agent insofar as it is not associated with dependence. Its efficacy and safety have been evaluated in three double-blind randomized clinical [...]
Management has not yet determined what indication will be pursued in the proof-of-concept study. However, etifoxine is prescribed (off-label) in Europe and other countries for depression. Furthermore, recent clinical studies have shown that increased neurosteroids have therapeutic effect for various depression indications, including Major Depressive Disorder and Post-Partum Depression. Accordingly, [...]
Neurosteroids could benefit the following neuropsychiatric and neurologic disorders: Green (1-11) – preclinical studies using Etifoxine which have demonstrated efficacy Blue (12) – Etifoxine is prescribed for depression in France (off-label), and clinical data demonstrates ALLO efficacy Purple (13-20) – preclinical and clinical studies suggest increasing biosynthesis of neurosteroids, [...]
GABA Therapeutics is conducting Phase 1 studies in Australia for the following reasons: Australian law allows clinical studies to commence before an IND is submitted, substantially expediting the program, and Current Australian tax law provides for a 43.5% tax rebate on eligible clinical related costs.
GABA Therapeutics will be conducting the following Phase 1 studies: Initially etifoxine will be studied to measure its ability to increase endogenous neurosteroids in man. Secondly, GRX-917 (deuterated etifoxine) will be studied for toxicology, safety, dosing and its ability to increase endogenous neurosteroids in man.
Why is increasing Endogenous Neurosteroids a Better Therapeutics Approach than dosing Exogenous Neurosteroids?
The human brain is a complex network of billions of interconnected cells, organized in many networks communicating with one another. Some CNS disorders arise from dysregulation in the modulation of these networks, either by altered levels of signaling molecules like neurosteroids or the receptors they target. Boosting the brain’s natural [...]
Neurosteroids, like allopregnanolone (ALLO), are natural signaling molecules made in the brain from cholesterol and are essential for normal brain biochemistry. They can induce potent anxiolytic, antidepressant, anticonvulsant, and analgesic effects, mainly through interaction with the GABA channel, the main inhibitory system in the brain. In addition to these psychopharmacological [...]
Etifoxine (and therefore GRX-917) has an excellent safety/pharmacological profile, based on a safety profile review by ANSM in France (2000-2012) which analyzed over 14 million prescriptions of etifoxine. Non addictive (no cases of abuse, misuse or pharmacodependence) No tolerance, withdrawal or rebound Low ADRs (21 per million) based on +14 [...]
Over 40 years of research and clinical data on etifoxine (and therefore GRX-917) has shown that the drug has little to no side effects: No Sedation (some people say slight sedation on day one which quickly remits) No Cognitive Impairment No Ataxia
Etifoxine (and therefore GRX-917) has been shown through multiple published, peer reviewed clinical studies, to have comparable rapid onset and efficacy to leading benzodiazepines, including like alprazolam (Xanax™) and lorazepam (Ativan™).