CMX-020 is a new molecular entity that is being developed as a non-opioid analgesic. Both intravenous and oral formulations of CMX-020 are available.
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 neuropathic pain
- Management of osteoarthritis
- Management of mild to severe pain (as an alternative to acetaminophen, NSAIDs and opioids)
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 35 minutes in human. Preclinically, intravenous CMX-020 has a maximal analgesic dose response similar to intravenous remifentanil, which indicates no analgesic ceiling. However, unlike remifentanil, intravenous CMX-020 shows no depression of respiration or blood pressure. The intravenous formulation has been studied in Phase 1A safety and Phase 1B cold pressor trials in the United States. Currently, a Phase 1 maximum tolerated dose (MTD) study with intravenous CMX-020 is being conducted in Adelaide, Australia. Dosing for the MTD study will be completed in June 2018.
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)