ETIFOXINE & GRX-917 TIMELINE
Below is a timeline which illustrates the over 40 years of clinical data on etifoxine and the evolution of GRX-917.
GRX-917 (Improved Etifoxine) Patent Issues
Researchers improved etifoxine using deuteration technology by reducing its dosing requirements. The US patent to the new and improved etifoxine issued on September 25, 2018.
Compared etifoxine to lorazepam (Ativan®) – for alertness and cognitive functions in elderly patients
Etifoxine impairs neither alertness nor cognitive functions of the elderly: A randomized, double-blind, placebo-controlled crossover study D. Deplanque, F. Machuron, N. Waucquier, E. Jozefowicz, S. Duhem, S. Somers, O. Colin, A. Duhamel, R. Bordet
Safety Profile of Etifoxine: A French Pharmacovigilance Survey
Adverse drug reactions (ADRs) from over 14 million prescriptions of (Stresam®) etifoxine were reviewed and analyzed by the French National Agency for the Safety of Medicines and Health Products, between 2000 and 2012. The average incidence of ADRs was 0.0021% (21 per million treatments) and no cases of abuse, misuse or pharmacodependance were reported.
Compared etifoxine to alprazolam (Xanax®) – for safety and efficacy
Etifoxine Versus Alprazolam for the Treatment of Adjustment Disorder with Anxiety: a Randomized Controlled Trial Dan J. Stein
French 2009 Study – Found it is Safe to Drive on Etifoxine
A French study in 2009 found that Etifoxine was safe to drive on, classify it as Level 1 for the purposes of driving a vehicle.
Compared etifoxine to lorazepam (Ativan®) – established non-inferiority in adjustment disorder with anxiety ADWA
Efficacy of etifoxine compared to lorazepam monotherapy in the treatment of patients with adjustment disorders with anxiety: a double-blind controlled study in general practice N. Nguyen, E. Fakra, V. Pradel, E. Jouve, C. Alquier, M-E. Le Guern, J. Micallef, and O. Blin
Researchers Discover Etifoxine Enhances Neurosteroids
French researchers discovered that etifoxine has a dual mechanism of action: A) it works at GABA channels, and B) it increases neurosteroids more effectively than any other known compound.
Compared etifoxine with lorazepam (Ativan®) – for sedative and amnesic effects
A double blind parallel group placebo controlled comparison of sedative and amnesic effects of etifoxine and lorazepam in healthy subjects J. Micallef, C. Soubrouillarda, F. Gueta, M. E. Le Guernb, C. Alquierb, B. Bruguerollea, O. Blin
Etifoxine Patents Expire – Before its True Efficacy was Discovered
Etifoxine's patents expired during the mid 1980's, before the drug's true efficacy or mechanism of action was discovered. This explains why Etifoxine was never introduced into the United States or other major markets.
Etifoxine Approved for Anxiety in France
A small French distributor developed etifoxine for anxiety in France under the tradename Stresam and subsequently distributed the product throughout Eastern Europe, South America, South Africa and other small regions.
Hoechst Discovers Etifoxine
Etifoxine was developed by Hoechst of Germany in the 1960s. It was originally believed to be a mild benzodiazepine, because it didn’t sedate and scientists at the time did not have the technology to measure its true efficacy or determine its actual mechanism of action. Accordingly, it was deemed non-competitive with the drugs of the time, like Valium, and therefore never introduced into the United States.