Ketamine has been used in anesthesia since the 1960s and was added to the World Health Organization’s Model List of Essential Medicines in 1985. Ketamine is a very effective and novel pain reliever with research showing efficacy across a broad range of pain types (e.g., neuropathic, inflammatory, mechanical). Its effects upon pain are powerful and diverse3,4 and have proven equal or better than a number of strong opioid and opiate medications, including methadone, meperidine, fentanyl and morphine.5,6,7,8,9,10,11  Ketamine has distinct pharmacodynamics that allow reliable reduction of opioid use in pain management.16,17,18,19  Indeed, pain status improves with ketamine treatment over time rather than worsening20,21, likely due to its capacity to reverse hyperalgesia patterns that increase pain over time.  This specific problem – increasing hyperalgesia through opiate receptor mechanisms – is a disturbing byproduct of current standard of care in pain management and increases suffering and morbidity.22  In addition to established efficacy in pain management, dozens of studies have demonstrated efficacy in treating other indications outside the pain arena, and ketamine’s PK profile and safety parameters are understood, with data available on patients from ages 8 to 93. 

Pain treatment can be achieved at lower doses compared to depression

Existing pain research has established substantial pain relief with ketamine dosing strategies that are substantially lower than what has been effective in depression.  Lower dosing requirements can translate to fewer side effects and fewer total milligrams necessary for clinical effects and in population-wide circulation.   


Ketamine is already used to great effect by pain physicians, but delivery limitations exist

Interviews with key opinion leaders in pain management confirm substantial interest in a new low-dose ketamine delivery technology. There is notable enthusiasm for ketamine’s effects on pain and for Bexson Biomedical's approach pain management. 


The Opioid Public Health Emergency in pain management demands answers

The morbidity and mortality associated with the national opioid crisis has created a compelling mandate for safer treatments with large effect size.  This crisis, combined with a lack of alternative treatment options, displays that physicians need new treatment options, the FDA is motivated to review new, non-opioid pain therapies, and payers will reimburse new alternatives.


NMDA Receptor antagonists haven't materialized despite numerous applications

Pain management has not seen recent meaningful innovation, despite the national opioid crisis.  There are numerous pain conditions recognized in ICD-10 that might benefit from a new ketamine formulation that can safely deliver low-doses outside the clinic or hospital. Research has shown that ketamine can treat pain associated with the following conditions: 

  • Post Laminectomy Syndrome / Failed Back Syndrome

  • Acute Post-Operative Pain

  • Acute and Chronic Migraine

  • Neuropathic Pain from Spinal Cord Injury

  • Fibromyalgia / Diffuse Connective Tissue diseases

  • Cervical Spine Trauma / Whiplash

  • Pain due to Nerve Injury

  • Chronic Neuropathy

  • Traumatic Neuropathy

  • Ischemic Limb Pain

  • Mechanical Allodynia

  • Post Herpetic Neuralgia

  • Trigeminal Neuralgia