Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TV-46763 · 1 trial · 1 indication
The SPID48 was calculated as the time-weighted sum of pain intensity difference (PID) at each time point over 48 hours. The SPID48 was based on the NPRS-11, which is an 11-point Likert-type scale in which 0 means no pain and 10 means the most intense pain imaginable. Least square (LS) mean was calculated using an analysis of covariance (ANCOVA) with treatment and center as factors and the baseline pain intensity score as a covariate. Multiple imputation method was used to handle missing data.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matching to TV46763 (hydrocodone bitartrate/acetaminophen) immediate release (IR) tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants will continue to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period. |
| TV-46763 5.0 mg/325 mg | EXPERIMENTAL | Participants will receive TV46763 (hydrocodone bitartrate/acetaminophen) 5.0 mg/325 mg IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants will continue to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period. |
| TV-46763 7.5 mg/325 mg | EXPERIMENTAL | Participants will receive TV46763 (hydrocodone bitartrate/acetaminophen) 7.5 mg/325 mg IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants will continue to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period. |
| TV-46763 10.0 mg/325 mg | EXPERIMENTAL | Participants will receive TV46763 (hydrocodone bitartrate/acetaminophen) 10.0 mg/325 mg IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants will continue to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period. |
| Name | Type | Description |
|---|---|---|
| TV-46763 | DRUG | TV-46763 will be administered per dose and schedule specified in the arm description. |
| Placebo | DRUG | Placebo matching to TV-46763 will be administered per schedule specified in the arm description. |
Inclusion Criteria: 1. Men and women aged 18 to 75 years, inclusive. 2. Participants who are scheduled to undergo a primary unilateral first metatarsal Austin bunionectomy with distal osteotomy and internal fixation without any collateral procedures (ie, uncomplicated procedure). 3. Participants wh...
TV-46763 is an investigational small molecule being developed for the treatment of pain. It is a combination product containing hydrocodone bitartrate and acetaminophen in immediate-release tablet form, intended to provide analgesic efficacy for patients experiencing moderate to severe pain.
TV-46763 is being developed by Teva Pharmaceutical Industries Limited, a company publicly traded under the ticker symbol TEVA. The drug is currently in clinical development and has not been approved by regulatory authorities.
TV-46763 is in Phase 3 clinical development. It has completed one Phase 3 trial, and the drug remains investigational, meaning it has not yet received regulatory approval and is still undergoing clinical evaluation for safety and efficacy.
TV-46763 has been studied in one completed Phase 3 clinical trial, identified as NCT02487108. This randomized, double-blind, placebo-controlled study evaluated the analgesic efficacy and safety of hydrocodone bitartrate/acetaminophen immediate-release tablets in 569 participants with moderate to severe pain following bunionectomy in the United States.
TV-46763 is a combination product containing hydrocodone bitartrate and acetaminophen in an immediate-release tablet formulation. The clinical trial for TV-46763 specifically evaluated this combination for its analgesic effects in patients with moderate to severe pain following bunionectomy.