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Also known as Fentanyl Buccal Tablet
Fentanyl Buccal · 1 trial · 1 indication
Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
| Arm | Type | Description |
|---|---|---|
| Fentanyl buccal tablet first then immediate release oxycodone | EXPERIMENTAL | This crossover study includes a screening period, two titration periods, two double-blind treatment periods during which subjects will be randomized to receive fentanyl buccal tablet (FBT) plus placebo during the first treatment period and then immediate release oxycodone plus placebo during the second treatment period or vice versa, then followed by a 12-week open-label treatment period with FBT or an alternative short acting opioid. |
| Immediate Release Oxycodone first then FBT | EXPERIMENTAL | This crossover study includes a screening period, two titration periods, two double-blind treatment periods during which subjects will be randomized to receive fentanyl buccal tablet (FBT) plus placebo during the first treatment period and then immediate release oxycodone plus placebo during the second treatment period or vice versa, then followed by a 12-week open-label treatment period with FBT or an alternative short acting opioid. |
| Name | Type | Description |
|---|---|---|
| Fentanyl Buccal Tablet | DRUG | FBT dose strengths = 200, 400, 600, or 800 mcg (1, 2, 3, or 4 tablets) taken prn (as needed) in the event of breakthrough pain. The maximum dose of FBT permitted during the titration and double-blind periods in this study is 800 mcg (4 tablets). For the subsequent 12-week open-label treatment period, patients will either continue with FBT treatment or begin treatment with an alternative short-acting opioid deemed appropriate for each patient by the clinician. |
| Immediate release oxycodone | DRUG | Immediate release oxycodone dosage strength: 15, 30, 45, and 60 mg doses (1, 2, 3 or 4 capsules) to be taken prn (as needed) for breakthrough pain. The maximum single dose would be 60 mg (4 capsules). |
Key Inclusion Criteria: * The patient has chronic pain of at least 3 months duration associated with any of the following conditions: diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain, fibromyalgia, chronic pancreatitis, o...
Top 4 of 15 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 4 | PHASE3 | Retatrutide, LY3016859, LY3556050, LY3526318, LY3857210 |
| Fortress Biotech, Inc. | FBIO | 1 | PHASE3 | Tramadol |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | MK-6916 |
| Creative Medical Technology Holdings, Inc. | CELZ | 1 | PHASE1 | CELZ-201-DDT |
Fentanyl Buccal is used for the management of chronic pain. It is a small molecule therapeutic developed by Teva Pharmaceutical Industries Limited, and it has been studied in a Phase 3 clinical trial in patients with chronic pain, including those experiencing breakthrough pain.
Fentanyl Buccal works by targeting the mu-opioid receptor, encoded by the OPRM1 gene. It acts as an agonist at this receptor, meaning it activates the receptor to produce analgesic effects. This mechanism underlies its use in chronic pain management.
Fentanyl Buccal is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker symbol TEVA. Teva is the company responsible for the development and clinical evaluation of this product.
Fentanyl Buccal is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 3 trial has been completed, but no regulatory approval has been granted.
Fentanyl Buccal has been evaluated in a completed Phase 3 clinical trial, NCT00813488, titled "Fentanyl Buccal Tablets Versus Immediate Release Oxycodone for Breakthrough Pain in Patients With Chronic Pain." The trial enrolled 213 participants in the United States and was randomized, double-blind, and controlled.
Yes, Fentanyl Buccal is also known as Fentanyl Buccal Tablet. These names refer to the same product developed by Teva Pharmaceutical Industries Limited for the treatment of chronic pain.