Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as lidocaine patch 5%, Lidocaine patch 5%
Lidocaine patch 1.8% · 2 trials · 1 indication
Adhesion of the product to the skin is assessed by the FDA 0-4 scoring system. The scoring for adhesion is indicated as follows: 0 = ≥ 90% Adhered (essentially no lift off the skin), 1 = ≥ 75% to \< 90% Adhered (some edges only lifting off the skin), 2 = ≥ 50% to \< 75% Adhered (less than half of the patch lifting off the skin), \> 0% to \< 50% Adhered but not detached (more than half of the patch lifting off the skin without falling off), and 4 = 0% adhered (patched completely detached). Adhesion is assessed every 3 hours for 12 hours. The mean cumulative adhesion score is calculated as the sum of scores at each assessment time point divided by the total number of observations.
Adhesion of the product to the skin is assessed by the EMA 0-6 scoring system. The scoring for adhesion is indicated as follows: 0 = \< 70% Adhered, 1 = \> 70% Adhered, 2 = \> 75% Adhered, 3 = \> 80% Adhered, 4 = \> 85% Adhered, 5 = \> 90% adhered, and 6 = \> 95% Adhered. Adhesion is assessed every 3 hours for 12 hours. The mean cumulative adhesion score is calculated as the sum of scores at each assessment time point divided by the total number of observations.
Peak plasma concentration of lidocaine after application of 3 patches for 12 hours
Area under the plasma concentration versus time curve from 0 to 48 hours of lidocaine in plasma
Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plasma
| Arm | Type | Description |
|---|---|---|
| Lidocaine Patch (Sequence ABC) | EXPERIMENTAL | Subjects received all three topical lidocaine products in Periods 1, 2, and 3. The sequence in which they received the lidocaine products was determined by random assignment. For subjects in Arm 1, 3 lidocaine 1.8% patches were applied in Period 1, and 3 lidocaine 5% patches were applied in Period 2, and 3 lidocaine 5% medicated plasters were applied in Period 3. |
| Lidocaine Patch (Sequence CAB) | EXPERIMENTAL | Subjects received all three topical lidocaine products in Periods 1, 2, and 3. The sequence in which they received the lidocaine products was determined by random assignment. For subjects in Arm 2, 3 lidocaine 5% medicated plasters were applied in Period 1, and 3 lidocaine 1.8% patches were applied in Period 2, and 3 lidocaine 5% patches were applied in Period 3. |
| Lidocaine Patch (Sequences BCA) | EXPERIMENTAL | Subjects received all three topical lidocaine products in Periods 1, 2, and 3. The sequence in which they received the lidocaine products was determined by random assignment. For subjects in Arm 3, 3 lidocaine 5% patches were applied in Period 1, and 3 lidocaine 5% medicated plasters were applied in Period 2, and 3 lidocaine 1.8% patches were applied in Period 3. |
| Lidocaine Patch (Sequence AB) | EXPERIMENTAL | Subjects received all study treatments: a bolus IV injection of 0.7 mg/kg lidocaine IV in the morning of study Day 1, and then lidocaine patch treatment on Day 8 and Day 15. The sequence in which they received patch treatment was determined by random assignment. For subjects in Arm 1, 3 lidocaine 1.8% patches were applied on Day 8 and 3 Lidoderm® 5% patches were applied on Day 15. |
| Lidocaine Patch (Sequence BA) | EXPERIMENTAL | Subjects received all study treatments: a bolus IV injection of 0.7 mg/kg lidocaine IV in the morning of study Day 1, and then lidocaine patch treatment on Day 8 and Day 15. The sequence in which they received patch treatment was determined by random assignment. For subjects in Arm 2, 3 Lidoderm® 5% patches were applied on Day 8 and 3 lidocaine 1.8% patches were applied on Day 15. |
| Name | Type | Description |
|---|---|---|
| Lidocaine patch 1.8% | DRUG | Three patches are applied to the subject's back for 12 hours. |
| Lidocaine patch 5% | DRUG | Three patches are applied to the subject's back for 12 hours. |
| Lidocaine medicated plaster 5% | DRUG | Three plasters are applied to the subject's back for 12 hours. |
| Lidocaine 5% patch | DRUG | - |
| Lidocaine 2% Injectable Solution | DRUG | - |
Key Inclusion Criteria: * Must be healthy based on by medical history, laboratory work, and physical exam with BMI range between 18.00 and 30.00 kg/m2 inclusive. * Non-smokers * Be at least 18 years of age * If childbearing potential, use of acceptable form of birth control * In the case of females...