STUDIES IN GRX-917
User Notes
- GRX-917 is deuterated (metabolically improved) etifoxine, with identical safety and efficacy (same biology, pharmacology and mechanism of action).
- Therefore, clinical safety and efficacy studies in etifoxine predict clinical safety and efficacy for GRX-917.
- Click any research or file name below and the original study or file will appear in a separate browser.
- Additional files or data can be requested by emailing our Chief Scientific Officer: dputman@gabarx.com.
Preclinical Data Files in GRX-917
GRX-917 – Identical Mechanism of Action as Etifoxine
GRX-917 – Identical Metabolite Profile as Etifoxine
GRX-917 – Superior Pharmacokinetic Profile to Etifoxine
Clinical Studies of GRX-917
GRX-917 Phase 1 Data
GRX-917 – Identical Mechanism of Action as Etifoxine
STUDIES IN ETIFOXINE
Clinical Studies of Etifoxine in Anxiety
Comparisons to Benzodiazepines
Compared etifoxine to clonazepam (Klonopin®) – established non-inferiority in GAD, panic and various phobias
Compared etifoxine to lorazepam (Ativan®) – established non-inferiority in adjustment disorder with anxiety ADWA
Compared etifoxine to alprazolam (Xanax®) – for safety and efficacy
Compared etifoxine with lorazepam (Ativan®) – for sedative and amnesic effects
Compared etifoxine to lorazepam (Ativan®) – for alertness and cognitive functions in elderly patients
Compared etifoxine to phenazepam – for efficacy in adjustment disorders (Russian translation using Google translate)
Comparison to a Serotonergic
7. Compared etifoxine to buspirone – established efficacy and safety in adjustment disorder with anxiety ADWA (original French study)
7A. Compared etifoxine to buspirone – established efficacy and safety in adjustment disorder with anxiety ADWA (English translation of results)
Additional
8. Etifoxine Leads to Relief of Anxiety, Pain and Joint Syndrome
Pharmacovigilance
Safety Profile of Etifoxine: A 2012 French Pharmacovigilance Survey (14 million prescriptions)
2014 ANSM Label Update to Etifoxine
French 2009 Study – Found it is Safe to Drive on Etifoxine
Etifoxine Psychological and Motor Tests
Stresam® Labeling and Marketing Materials
Stresam® Leaflet
Stresam® Package Insert (French)
Stresam® Summary of Product Characteristics (SPC)
Stresam® Clinical Summary
Stresam® Electronic Brochure (Spanish)
EMA 2022 Reauthorization of Etifoxine (Stresam®)
Pre-Clinical Studies of Etifoxine: Anxiety & Other Indications
Etifoxine for Arthritis Pain
Etifoxine and Analgesic Strategies
Analgesic and Anti-Edemic Properties of Etifoxine
Etifoxine for Cancer Pain
Etifoxine for Neuropathic Pain
Etifoxine for Mononeuropathy
Etifoxine Causes Neurosteroid Biosynthesis
Etifoxine Increases Neurosteroid Levels
Etifoxine Causes Neurosteroid Biosynthesis at TSPO
Etifoxine During Spinal Nociceptive Processing
Etifoxine for Axonal Regeneration and Neuroinflammation
Etifoxine Preventive and Curative Effects in Brain Edema
Etifoxine Improves Peripheral Nerve Regeneration and Functional Recovery
Etifoxine Protects Against Cerebral Ischemia/Reperfusion Injury (Stroke)
Etifoxine is Protective in Multiple Sclerosis
Etifoxine for Treating Age-Related Macular Degeneration (Retinal)
Etifoxine inhibits the Nod-like Receptor Protein-3 (NLRP3) inflammasome-mediated autoinflammation pathway
Neurosteroids (General Studies)
Preclinical and Clinical Evidences for Dysregulation of Neurosteroidogenesis in Neuropsychiatric and Neurologic Disorders
Translocator Protein (18 kDa) (TSPO) as a Therapeutic Target for Neurological and Psychiatric Disorders
Neurosteroids and their Relevance to Translational Research
INTELLECTUAL PROPERTY
GABA Therapeutics Patents
Deuterated Analogs of Etifoxine – US Patent No. 10,080,755, dated September 25, 2018
S-Etifoxine – US Patent No. 8,110,569 B2, dated February 7 2012
BUSINESS PUBLICATIONS
GABA Therapeutics Patents
The Development of Deuterium-Containing Drugs
Protecting Deuterated Drugs
First Deuterated Drug Approved
