Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Immediate release oxycodone · 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...
Immediate release oxycodone is used for chronic pain. It is a small molecule being developed by Teva Pharmaceutical Industries Limited. The drug is currently in Phase 3 clinical development for this indication.
Teva Pharmaceutical Industries Limited (ticker: TEVA) is developing immediate release oxycodone. The drug is a small molecule intended for the treatment of chronic pain and is currently in Phase 3 clinical trials.
Immediate release oxycodone is in Phase 3 clinical development. It is an investigational drug being studied for chronic pain. The Phase 3 trial has been completed, and the drug has not yet been approved by regulatory authorities.
Immediate release oxycodone was studied in a Phase 3 clinical trial with the identifier NCT00813488. This trial, titled "Fentanyl Buccal Tablets Versus Immediate Release Oxycodone for Breakthrough Pain in Patients With Chronic Pain," was completed and enrolled 213 participants in the United States.
No, immediate release oxycodone is not the same as fentanyl buccal tablets. In the clinical trial NCT00813488, immediate release oxycodone was compared against fentanyl buccal tablets for the treatment of breakthrough pain in patients with chronic pain. They are different drugs.