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Also known as OraVescent fentanyl citrate, OraVescent fentanyl (OVF)
OraVescent fentanyl · 6 trials · 8 indications
| Name | Type | Description |
|---|---|---|
| OraVescent Fentanyl | DRUG | - |
| ORAVESCENT Fentanyl Citrate | DRUG | - |
| OraVescent fentanyl (OVF) | DRUG | - |
Inclusion Criteria: * Chronic pain diagnosis * Opioid tolerant * Has on average 1-4 breakthrough pain episodes per day Exclusion Criteria: * Drug abuse history * Cardiopulmonary disease * Monoamine oxidase inhibitors (MAOIs) * Expected to have surgery to relieve the pain
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 2 | PHASE3 | Camlipixant |
| Trevi Therapeutics, Inc. | TRVI | 1 | PHASE2 | Haduvio (nalbuphine ER) |
OraVescent fentanyl is an investigational small molecule pain therapy developed by Teva Pharmaceutical Industries Limited. It is being studied for the management of breakthrough pain in opioid-tolerant patients with chronic pain conditions, including chronic low back pain and chronic neuropathic pain. It has completed Phase 3 clinical trials but is not approved.
OraVescent fentanyl is being studied for the management of breakthrough pain in opioid-tolerant patients with noncancer-related chronic pain. Clinical trials have enrolled patients with chronic low back pain, chronic neuropathic pain, low back pain, migraine, diabetic neuropathies, and osteoarthritis. It remains investigational and has not been approved for any indication.
OraVescent fentanyl is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva sponsored the Phase 3 clinical program evaluating the drug for breakthrough pain in opioid-tolerant patients with chronic noncancer pain.
OraVescent fentanyl has completed Phase 3 clinical development. All three of its registered trials are Phase 3 studies and all are listed as completed, with no active trials ongoing. The drug is investigational and has not been approved by the FDA for any indication.
OraVescent fentanyl has been evaluated in completed Phase 3 trials including NCT00343733 in noncancer-related chronic pain, NCT00228605 in low back pain and related conditions, NCT00214955 in chronic neuropathic pain, and NCT00214942 in chronic low back pain. These studies enrolled opioid-tolerant adults and were conducted in the United States.
Yes. OraVescent fentanyl citrate, OraVescent fentanyl (OVF), and ORAVESCENT Fentanyl Citrate are alternative names for the same investigational drug developed by Teva Pharmaceutical Industries Limited. Searches using any of these names refer to the same Phase 3 pain program.