Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3023703 · 3 trials · 2 indications
Pain intensity was rated by the participant on a 100-mm VAS: 0 mm (no pain) and 100 mm (worst pain imaginable). The participant marked the line at the point that corresponded with his or her perception of pain. Weighted mean change from baseline was calculated as: \[the area under the change in pain intensity versus time curve\] / 8 hours (h). The baseline pain intensity was the pain assessment prior to dosing of study medication (0 h). Least Squares (LS) mean were calculated using a Bayesian analysis of covariance analysis (ANCOVA) adjusted for treatment as a fixed effect and baseline pain VAS as a continuous covariate. The measure of dispersion reported is 95% Credible Interval (CrI) not Confidence Interval (CI). A negative direction indicates a pain reduction from baseline.
A summary of serious and all other non-serious adverse events (AE), regardless of possible study drug relatedness, is located in the Reported Adverse Events module.
AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible study drug relatedness, is located in the Reported Adverse Events module.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Part A: Single oral administration of placebo matching corresponding LY3023703 dose administered orally once as a capsule post dental surgery. Part B: Single oral administration of placebo matching corresponding LY3023703 administered orally once as a capsule, post dental surgery and post dialysate probe placement. Part B of this study assessed whether LY3023703 selectively inhibited the prostaglandin E(PGE) surge in the wound dialysate during the postoperative period. |
| 30 milligrams (mg) LY3023703 | EXPERIMENTAL | Part A: Single oral administration of 30 milligrams (mg) LY3023703 administered orally once as a 30-milligrams (mg) capsule post dental surgery. Part B: Single oral administration of 30 milligrams (mg) LY3023703 administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement. Part B of this study assessed whether LY3023703 selectively inhibited the prostaglandin E(PGE) surge in the wound dialysate during the postoperative period. |
| 400 mg Celecoxib | ACTIVE_COMPARATOR | Part A: Single oral administration of 400 mg celecoxib (Positive control) administered orally once as two 200-mg capsules post dental surgery (Positive control). Participants received two 200-mg celecoxib capsules during Pre-Part B.The purpose of Pre-Part B was to develop proficiency in the dialysate placement, collection, and maintenance techniques before moving to Part B. Celecoxib was not administered in Part B. Part B of this study assessed whether LY3023703 selectively inhibited the prostaglandin E(PGE) surge in the wound dialysate during the postoperative period. |
| LY3023703 | EXPERIMENTAL | Escalating doses (2.5 milligram \[mg\] up to 30 mg) of LY3023703 administered orally, QD, for 28 days |
| Celecoxib | ACTIVE_COMPARATOR | 400 mg celecoxib administered orally, QD, for 28 days. (Positive control.) |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Administered orally |
| LY3023703 | DRUG | Administered orally |
| Celecoxib | DRUG | Administered orally |
Inclusion Criteria: * Have at least 2 third molars which are clinically indicated for extraction. At least 1 molar should be a mandibular third molar with partial or complete bony impaction * Are overtly healthy as determined by medical history and limited physical examination Exclusion Criteria: ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Fresenius Medical Care AG Sponsored ADR | FMS | 2 | PHASE3 | Dialysis |
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| CalciMedica, Inc. | CALC | 1 | PHASE2 | Auxora |
| Talphera, Inc. | TLPH | 1 | N/A | Undisclosed |
| SeaStar Medical Holding Corporation | ICU | 2 | - | Undisclosed |
| Collegium Pharmaceutical, Inc. | COLL | 1 | - | Flozin |
LY3023703 is an investigational small molecule being studied for acute pain, specifically pain relief after wisdom teeth removal, and has also been evaluated in healthy volunteers. It is being developed by Eli Lilly and Company and is currently in Phase 2 clinical development.
LY3023703 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is an investigational small molecule intended for the treatment of acute pain.
LY3023703 is in Phase 2 clinical development. It has completed two Phase 1 trials in healthy volunteers and one Phase 2 trial in patients with acute pain following wisdom teeth removal. The drug is not approved and remains investigational.
LY3023703 has completed three clinical trials: NCT01632579, a single-dose Phase 1 study in healthy participants; NCT01849055, a multiple-dose Phase 1 study in healthy participants; and NCT01872910, a Phase 2 study testing pain relief after wisdom teeth removal in patients with acute pain.
LY3023703 is not FDA approved. It is an investigational drug that has completed Phase 1 and Phase 2 clinical trials, but it remains in clinical development and has not been authorized for marketing by the FDA.