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...
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Etoricoxib 4% DMSO is a topical gel formulation of etoricoxib, a small molecule drug being developed by Organon & Co. for osteoarthritis pain. It is applied to the skin as a gel containing 4% dimethyl sulfoxide (DMSO). The drug is currently in Phase 1 clinical development.
Etoricoxib 4% DMSO is being developed for the treatment of osteoarthritis pain. It is a topical gel formulation designed to deliver etoricoxib through the skin. The drug has been studied in a Phase 1 clinical trial in participants with osteoarthritis pain.
Etoricoxib 4% DMSO targets PTGS2, also known as cyclooxygenase-2 (COX-2). It acts as an inhibitor of this enzyme. By inhibiting PTGS2, the drug is designed to reduce pain and inflammation associated with osteoarthritis.
Etoricoxib 4% DMSO is being developed by Organon & Co., which trades under the ticker symbol OGN. Organon is the sponsor of the clinical trial evaluating this topical gel formulation for osteoarthritis pain.
Etoricoxib 4% DMSO is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial has been completed.
Etoricoxib 4% DMSO has been studied in one clinical trial, NCT01980940, titled "The Single Dose Pharmacokinetics of Two and Proof of Efficacy of One New Etoricoxib Gel Formulation in Participants With Osteoarthritis (MK-0663-168)." This Phase 1 trial was completed and enrolled 70 participants.