EFFICACY

Intravenous CMX-020 is equivalent to the maximum efficacy of remifentanil

Intravenous Formulation of CMX-020

The intravenous version of CMX-020 is delivered using an aqueous formulation. The half-life of intravenous CMX-020 is 45 minutes in human. Preclinically, intravenous CMX-020 has a maximal analgesic dose response in the tail-flick assay similar to intravenous remifentanil, which indicates no analgesic ceiling. However, unlike remifentanil, intravenous CMX-020 shows no depression of respiration or blood pressure. Cmxtwenty recently completed a Phase 1 maximum tolerated dose (MTD) clinical study with intravenous CMX-020 in Australia. The results of this MTD safety study indicates intravenous CMX-020 has the potential to match the highest levels of analgesia of intravenous opioids, without opioid’s respiratory depression, constipation, nausea, dizziness, fatigue, or addiction. With a half-life of 45 minutes, intravenous CMX-020 can be utilized in operative settings or in post-operative settings with patient-controlled analgesia. A Phase 2 POC study for pain associated with hip/knee replacement is in the planning stages.

Projected Indications for Intravenous CMX-020

  • Management of acute peri-operative pain
  • Management of pain with Propofol in anesthesia
  • Management of pain in a hospital setting via patient-controlled analgesia (PCA)

Oral Formulation of CMX-020

The oral version of CMX-020 is delivered using an enteric-coated softgel. Phase 1 and Phase 2 trials were carried out using the oral formulation. Results from a recently completed Phase 2 POC study in sciatica suggest 375 mg daily of CMX-020 is well tolerated. A post hoc analysis suggests the safety profile of CMX-020 is better than pregabalin since no patients who received CMX-020 reported dizziness, somnolence, fatigue, or vertigo. Based on a comparison with a similar population of patients in a published study, CMX-020 appeared to show slightly better efficacy than pregabalin. In sciatica patients, CMX-020 improved quality of life measures.

Projected Indications for Oral CMX-020

  • Management of pain associated with diabetic peripheral neuropathy
  • Management of osteoarthritis
  • Management of neuropathic pain
  • Management of mild to severe pain (as an alternative to acetaminophen, NSAIDs and opioids)

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