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: [email protected].

Preclinical Data Files in GRX-917

1. GRX-917 – Identical Mechanism of Action as Etifoxine

2. GRX-917 – Identical Metabolite Profile as Etifoxine

3. GRX-917 – Superior Pharmacokinetic Profile to Etifoxine

Clinical Studies of GRX-917

GRX-917 Phase 1 Data

Pharmacodynamic Profile of GRX-917 Using Quantitative EEG in a Phase 1 Study

STUDIES IN ETIFOXINE

Clinical Studies of Etifoxine in Anxiety

Comparisons to Benzodiazepines

1. Compared etifoxine to clonazepam (Klonopin®) – established non-inferiority in GAD, panic and various phobias

2. Compared etifoxine to lorazepam (Ativan®) – established non-inferiority in adjustment disorder with anxiety ADWA

3. Compared etifoxine to alprazolam (Xanax®) – for safety and efficacy

4. Compared etifoxine with lorazepam (Ativan®) – for sedative and amnesic effects

5. Compared etifoxine to lorazepam (Ativan®) – for alertness and cognitive functions in elderly patients

6. 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

1. Safety Profile of Etifoxine: A 2012 French Pharmacovigilance Survey (14 million prescriptions)

2. 2014 ANSM Label Update to Etifoxine

3. French 2009 Study – Found it is Safe to Drive on Etifoxine

4. Etifoxine Psychological and Motor Tests

Stresam® Labeling and Marketing Materials 

1. Stresam® Leaflet

2. Stresam® Package Insert (French)

3. Stresam® Summary of Product Characteristics (SPC)

4. Stresam® Clinical Summary

5. Stresam® Electronic Brochure (Spanish)

6. EMA 2022 Reauthorization of Etifoxine (Stresam®)

Pre-Clinical Studies of Etifoxine: Anxiety & Other Indications

1.    Etifoxine for Arthritis Pain

2.    Etifoxine and Analgesic Strategies

3.    Analgesic and Anti-Edemic Properties of Etifoxine

4.    Etifoxine for Cancer Pain

5.    Etifoxine for Neuropathic Pain

6.    Etifoxine for Mononeuropathy

7.    Etifoxine Causes Neurosteroid Biosynthesis

8.    Etifoxine Increases Neurosteroid Levels

9.    Etifoxine Causes Neurosteroid Biosynthesis at TSPO

10.  Etifoxine During Spinal Nociceptive Processing

11.   Etifoxine for Axonal Regeneration and Neuroinflammation

12.   Etifoxine Preventive and Curative Effects in Brain Edema

12.   Etifoxine Improves Peripheral Nerve Regeneration and Functional Recovery

13.   Etifoxine Protects Against Cerebral Ischemia/Reperfusion Injury (Stroke)

14.   Etifoxine is Protective in Multiple Sclerosis

15.   Etifoxine for Treating Age-Related Macular Degeneration (Retinal)

16. Etifoxine inhibits the Nod-like Receptor Protein-3 (NLRP3) inflammasome-mediated autoinflammation pathway

Neurosteroids (General Studies)

1. Preclinical and Clinical Evidences for Dysregulation of Neurosteroidogenesis in Neuropsychiatric and Neurologic Disorders

2. Translocator Protein (18 kDa) (TSPO) as a Therapeutic Target for Neurological and Psychiatric Disorders

3. Neurosteroids and their Relevance to Translational Research

INTELLECTUAL PROPERTY

GABA Therapeutics Patents

1. Deuterated Analogs of Etifoxine – US Patent No. 10,080,755, dated September 25, 2018

2. S-Etifoxine – US Patent No. 8,110,569 B2, dated February 7 2012

BUSINESS PUBLICATIONS

1. The Development of Deuterium-Containing Drugs

2. Protecting Deuterated Drugs

3. First Deuterated Drug Approved