Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Etoricoxib 4% DMSO · 1 trial · 1 indication
Cmax determined for the period up to 72 hours post-single application. Descriptive statistics are expressed as the geometric least squares mean (GLSM). Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).
Tmax determined for the period up to 72 hours post-single application.
Area under the observed concentration-time curve from time zero to the last quantifiable time point determined for the period up to 72 hours post-single application. The area was calculated according to the linear up/log down trapezoidal rule. AUC0-last is an estimate of total plasma exposure. Descriptive statistics are expressed as the GLSM. AUC with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).
The WOMAC VA 3.1 Pain subscale is a self-administered questionnaire assessing lower extremity pain due to osteoarthritis that was completed by participants 2 to 3 hours post morning dose. The WOMAC Pain Subscale had five questions with answers to each item assessed on a 100 mm VA scale (0 = no pain; 100 = extreme pain). The score for each item was summed and the overall score ranged from 0 to 500 (increasing severity). The time weighted average up to day x was calculated as the sum of rectangles under the curve for successive intervals prior to day x as defined by timepoints at which assessments were made. The time weighted change from baseline was calculated. A negative mean change from baseline indicates improvement in pain.
| Arm | Type | Description |
|---|---|---|
| Pt 1: ETOR 75 DMSO/ETOR 150 PG/ETOR 75 PG/ETOR 150 DMSO | EXPERIMENTAL | Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel. All treatments were applied topically. |
| Pt 1: ETOR 75 PG/ETOR 75 DMSO/ETOR 150 DMSO/ETOR 150 PG | EXPERIMENTAL | Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel. All treatments were applied topically. |
| Pt 1: ETOR 150 DMSO/ETOR 75 PG/ETOR 150 PG/ETOR 75 DMSO | EXPERIMENTAL | Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel. All treatments were applied topically. |
| Pt 1: ETOR 150 PG/ETOR 150 DMSO/ETOR 75 PG/ETOR 75 DMSO | EXPERIMENTAL | Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically. |
| Pt 1: ETOR OD/ ETOR 150 DMSO/ ETOR 75 DMSO/ ETOR 75 PG | EXPERIMENTAL | Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel (DMSO formulation administered in error/overdose \[OD\]), followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically. |
| Pt 1: Placebo (Deviation) | OTHER | Participants randomized to a treatment sequence in Part 1 who received single dose placebo gel (1.97 or 3.94 mL) applied topically in error instead of active study drug and dropped out after the first treatment period in the sequence. Included in the safety assessments only. |
| Pt 2: ETOR 50 DMSO | EXPERIMENTAL | Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks. |
| Pt 2: Placebo | PLACEBO_COMPARATOR | Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks. |
| Name | Type | Description |
|---|---|---|
| Etoricoxib 75 mg 4% DMSO Gel | DRUG | Etoricoxib 75 mg 4% DMSO gel applied topically. |
| Etoricoxib 75 mg 4% PG Gel | DRUG | Etoricoxib 75 4% PG gel applied topically. |
| Etoricoxib 150 mg 4% DMSO Gel | DRUG | Etoricoxib 150 mg 4% DMSO gel applied topically. |
| Etoricoxib 150 mg 4% PG Gel | DRUG | Etoricoxib 150 mg 4% PG gel applied topically. |
| Etoricoxib 163 mg 4% DMSO gel | DRUG | Etoricoxib 163 mg 4% DMSO gel applied topically |
| Placebo | DRUG | Placebo gel applied topically. |
| Etoricoxib 50 mg 4% DMSO | DRUG | Etoricoxib 50 mg 4% DMSO gel applied topically. |
| Matching Placebo to Etoricoxib 50 mg 4% DMSO Gel | DRUG | Matching Placebo to Etoricoxib 50 mg 4% DMSO gel applied topically. |
Inclusion Criteria * Has diagnosis of osteoarthritis of the knee (tibio-femoral joint) for \>6 months based on clinical and radiographic criteria; * Has a diagnosis of American Rheumatology Association (ARA) functional Class I, II, or III; * The knee designated as the "study joint" must be the part...
Etoricoxib 4% DMSO is an investigational small molecule being studied for the treatment of osteoarthritis pain. It is a topical gel formulation of etoricoxib, a nonsteroidal anti-inflammatory drug, developed by Organon & Co. (NYSE: OGN). The drug is currently in Phase 1 clinical development.
Etoricoxib 4% DMSO is being developed by Organon & Co., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol OGN. The drug is in Phase 1 clinical development for the treatment of osteoarthritis pain.
Etoricoxib 4% DMSO is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, evaluating the drug in participants with osteoarthritis pain.
Etoricoxib 4% DMSO has one completed Phase 1 clinical trial, registered as NCT01980940. The trial, titled "The Single Dose Pharmacokinetics of Two and Proof of Efficacy of One New Etoricoxib Gel Formulation in Participants With Osteoarthritis (MK-0663-168)," enrolled 70 participants with osteoarthritis pain.
Etoricoxib 4% DMSO is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A single Phase 1 trial has been completed, but the drug has not yet progressed to later-stage trials or received regulatory approval.