Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication ZTLIDO is indicated for relief of pain associated with post-herpetic neuralgia (PHN) in adults. ZTLIDO contains lidocaine, an amide local anesthetic, and is indicated for relief of pain associated with post-herpetic neuralgia (PHN) in adults ( 1 ). FDA label
Also known as ZTlido (Lidocaine Topical System) 1.8%, ZTlido 1.8%, Lidocaine patch 1.8%, Lidocaine topical system 1.8%
ZTlido · 3 trials · 1 indication
The adhesion performance (i.e., degree of lifting or detachment) is assessed by clinicians at each time point. The adhesion of Test Products 1, 2, and 3 (each over-the-counter external analgesic lidocaine-containing patch) are compared to the adhesion performance observed for the Reference Product.
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 |
|---|---|---|
| ZTlido (Lidocaine Topical System) 1.8% | OTHER | - |
| Salonpas (Lidocaine Patch 4%) | OTHER | - |
| Aspercreme (Lidocaine Patch 4%) | OTHER | - |
| IcyHot (Lidocaine 4% + Menthol 1% Patch) | OTHER | - |
| 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 |
|---|---|---|
| ZTlido (Lidocaine Topical System) 1.8% | DRUG | 1 ZTlido (Lidocaine Topical System) 1.8% is applied predetermined area on the right or left side of the mid to upper back and worn for 12 hours |
| Salonpas (Lidocaine Patch 4%) | DRUG | 1 Salonpas (Lidocaine Patch 4%) is applied predetermined area on the right or left side of the mid to upper back and worn for 12 hours |
| Aspercreme (Lidocaine Patch 4%) | DRUG | 1 Aspercreme (Lidocaine Patch 4%) is applied predetermined area on the right or left side of the mid to upper back and worn for 12 hours |
| IcyHot (Lidocaine 4% + Menthol 1% Patch) | DRUG | 1 IcyHot (Lidocaine 4% + Menthol 1% Patch) is applied predetermined area on the right or left side of the mid to upper back and worn for 12 hours |
| 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 | - |
Inclusion Criteria: * Healthy, male and female subjects aged 18 years and older with a Body Mass Index (BMI) range 18.0-32.49 kg/m2 inclusive (according to the formula of BMI = weight (kg) / \[height (m)2\]). * Subjects who have no evidence of underlying disease during screening and check-in and wh...
ZTlido is a lidocaine topical system, also known as ZTlido (Lidocaine Topical System) 1.8% or ZTlido 1.8%. It is a small molecule product developed by Scilex Holding Company, which trades under the ticker SCLX. It is being studied in clinical development.
ZTlido is developed by Scilex Holding Company, which trades on the Nasdaq under the ticker SCLX. The company is the sponsor behind the clinical program for this lidocaine topical system.
ZTlido has been evaluated in a Phase 1 clinical trial. That study, NCT05106400, is completed. The program remains in clinical development, and no approval status is established by the available trial record.
ZTlido has been studied in one completed clinical trial, NCT05106400, titled a clinical adhesion study between ZTlido 1.8% and three over-the-counter external analgesic lidocaine-containing patches. The Phase 1 study enrolled 24 healthy adult volunteers in the United States and used a controlled, randomized design.
Yes. ZTlido is also known as ZTlido (Lidocaine Topical System) 1.8% and ZTlido 1.8%. These names refer to the same lidocaine topical system developed by Scilex Holding Company.
ZTlido is a lidocaine topical system. Its clinical program has focused on adhesion, including a completed Phase 1 study comparing ZTlido 1.8% with three over-the-counter external analgesic lidocaine-containing patches in healthy volunteers.