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Oxycodone DETERx · 1 trial · 1 indication
The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).
| Arm | Type | Description |
|---|---|---|
| Oxycodone DETERx | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Oxycodone DETERx | DRUG | 40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h |
| Placebo | DRUG | Placebo, divided into 2 doses, q12h |
Inclusion Criteria: * Male or non-pregnant female 18-75 years of age (inclusive) at the time of consent. * Must have a clinical diagnosis of moderate-to-severe CLBP for a minimum of 6 months prior to screening. * Must qualify for ATC opioid therapy for treatment of CLBP. * Must be classified as non...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 2 | PHASE3 | Camlipixant |
| Trevi Therapeutics, Inc. | TRVI | 1 | PHASE2 | Haduvio (nalbuphine ER) |
Oxycodone DETERx is an investigational, small molecule formulation of oxycodone developed by Collegium Pharmaceutical, Inc. (ticker: COLL) for the treatment of chronic low back pain. It is designed as an extended-release opioid analgesic and has been studied in a Phase 3 clinical trial in adults with chronic low back pain.
Oxycodone DETERx is being developed for the treatment of chronic low back pain in adults. Its clinical program has focused on this indication, with a completed Phase 3 trial enrolling 740 patients with chronic low back pain in the United States. It is not approved for any indication and remains investigational.
Oxycodone DETERx targets OPRM1, the mu-opioid receptor, and acts as an agonist at this receptor. This is the same molecular target as other oxycodone-based analgesics, and the DETERx formulation is designed to provide extended-release delivery of oxycodone for chronic pain management.
Oxycodone DETERx is being developed by Collegium Pharmaceutical, Inc., which trades under the ticker COLL. The company is the sponsor of the clinical development program for this extended-release oxycodone formulation in chronic low back pain.
Oxycodone DETERx is in Phase 3 development. One Phase 3 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.
Oxycodone DETERx has been studied in one completed Phase 3 trial, NCT01685684, titled Oxycodone DETERx Versus Placebo in Chronic Low Back Pain (CLBP). The trial was randomized, double-blind, and placebo-controlled, enrolling 740 adults aged 18 years and older in the United States.