Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Lidocaine topical system 1.8%, lidocaine topical system 1.8%
Lidocaine system 1.8% · 5 trials · 1 indication
Adhesion to skin assessed by FDA 0-4 scoring system. The scoring for adhesion of patches 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). The cumulative adhesion score is calculated as the sum of scores at each assessment time point (3, 4.5, 7, 8.5, and 12 hours).
Percent adhesion is assessed by laying a transparent sheet the exact size of the product over the top of the product and outlining areas of adhesion with a marker on the transparent sheet. The area excluded from the adhered area will be assessed to determine the degree of lift-off. Adhesion is assessed every 3 hours after product application. Mean percent adhesion 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 plamsa
Apparent dose of delivered lidocaine assessed by calculating the quantity of lidocaine in the patch as manufactured minus the quantity recovered from the used patch after 12 hours of wear and adhesive residue remaining on skin and on the product liner and envelope
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
Adhesion to skin assessed by FDA 0-4 scoring system. The scoring for adhesion of patches 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). The cumulative adhesion score is calculated as the sum of scores at each assessment time point.
| Arm | Type | Description |
|---|---|---|
| Lidocaine topical system with swimming (Treatment A) | EXPERIMENTAL | One topical system is applied to the mid- to upper-back for 12 hours. Subjects swim for 15 minutes in a heated pool 4 hours after topical system application. |
| Lidocaine topical system with showering (Treatment B) | EXPERIMENTAL | One topical system is applied to the mid- to upper-back for 12 hours. Subjects take a 10-minute shower 8 hours after topical system application. |
| Lidocaine topical system under normal conditions (Treatment C) | EXPERIMENTAL | One topical system is applied to the mid- to upper-back for 12 hours. Topical systems are not exposed to water during this period. |
| Lidocaine Patch (Sequence T1T2) | EXPERIMENTAL | Subjects receive both lidocaine topical system 1.8% and the generic lidocaine patch 5%. The sequence in which they receive the lidocaine products is determined by random assignment. For subjects in Arm 1, lidocaine 1.8% topical systems are applied in Period 1, and the generic lidocaine 5% patches are applied in Period 2. |
| Lidocaine Patch (Sequence T2T1) | EXPERIMENTAL | Subjects receive both lidocaine topical system 1.8% and the generic lidocaine patch 5%. The sequence in which they receive the lidocaine products is determined by random assignment. For subjects in Arm 2, generic lidocaine 5% patches are applied in Period 1, and the lidocaine 1.8% topical systems are applied in Period 2. |
| Lidocaine Patch (Sequence AB) | EXPERIMENTAL | Subjects received all study treatments: ZTlido and Lidoderm. On Day 1 (Period 1), three ZTlido lidocaine topical systems were applied to the skin on the back for 12 hours. On Day 8 (Period 2), three Lidoderm lidocaine patches were applied to the skin on the back for 12 hours. |
| Lidocaine Patch (Sequence BA) | EXPERIMENTAL | Subjects received all study treatments: ZTlido and Lidoderm. On Day 1 (Period 1), three Lidoderm lidocaine patches were applied to the skin on the back for 12 hours. On Day 8 (Period 2), three ZTlido lidocaine topical systems were applied to the skin on the back for 12 hours. |
| Lidocaine Topical System with Moderate Exercise (Treatment A) | EXPERIMENTAL | Three lidocaine topical systems 1.8% are applied to mid-lower back for 12 hours. Subjects are instructed to exercise 30 minutes on an exercise bicycle, achieving at heart rate of approximately 108 bpm. Exercise is performed after 2.5 hours, 5.5 hours, and 8.5 hours after topical system application. |
| Lidocaine Topical System with Heat Applied (Treatment B) | EXPERIMENTAL | Three lidocaine topical systems 1.8% are applied to mid-lower back for 12 hours. A heating pad is applied for 20 minutes at 2.5, 5.5, and 8.5 hours after the product is applied. |
| Lidocaine Patch | EXPERIMENTAL | All subjects received one lidocaine topical system, which was applied to a predetermined fixed area on subject's left side of the back or right side of the back (lower/mid back) according to randomization schedule and worn for 12 hours. |
| Name | Type | Description |
|---|---|---|
| Lidocaine topical system 1.8% | DRUG | lidocaine patch |
| lidocaine patch 5% | DRUG | One generic lidocaine patch is applied to the subject's back for 12 hours. |
Key Inclusion Criteria: * Must be healthy based on medical history, laboratory work, and physical exam * Body mass index ranging between 18.0-30.0 kg/m2, inclusive * Capable of unaided swimming * If childbearing potential, use of acceptable form of birth control * In case of females of childbearing...