ZTlido®: First and only lidocaine patch proven to maintain

Image representing more than 90% adhesion in more than 90% of patients at 12 hours. See references below.

More than 90% adhesion in more than 
90% of patients at 12 hours1

(full treatment duration as prescribed)

Study Design

  • Open-label adhesion performance study of ZTlido in 54 healthy adult subjects with normal activity

  • Adhesion assessed immediately after application (0 hour) and at 3, 6, 9, and 12 hours

Safety

  • No adverse events were reported throughout the duration of the study

Proven superiority to generic (Mylan) lidocaine patch (5%)2

3.5x greater mean adhesion at 12 hours in a head-to-head study2,3

Study Design2

  • Open-label, randomized study in 24 healthy adult subjects comparing adhesion performance of ZTlido to a generic (Mylan) lidocaine patch 5%

  • Adhesion assessed immediately after application (0 hour) and at 3, 6, 9, and 12 hours

  • Primary endpoint: Difference in mean percent adhesion

  • Subjects discouraged from sitting for extended time with the patch pressed against chairs, and not allowed to lie in beds or recliners. If a patch detached, a new patch was not applied3

Safety

  • Two dermal adverse events (pruritus) reported with ZTlido; none with the generic patch. Adverse events were not clinically significant2

At the end of the study, 0% of ZTlido patches and 29% of generic patches completely detached.2

ZTlido 1.8% is bioequivalent to Lidoderm® 5%4,5

Study Design

  • Single-center pharmacokinetic study in 54 healthy adult subjects to test for bioequivalence between ZTlido 1.8% and Lidoderm® 5%

  • Vigorous activity was prohibited at all times

ZTlido is designed to optimize lidocaine delivery via 
advanced patch technology

Even with 20x less medication, ZTlido delivers the same lidocaine dose (~15 mg) as Lidoderm® 5%4,6

(ZTlido: 36 mg lidocaine; Lidoderm®: 700 mg lidocaine)

ZTlido delivers 9x more bioavailability6,7

ZTlido: 45% | Lidoderm®: 3±2%

9x greater bioavailability is possible because ZTlido replaces conventional, thick hydrogel adhesive with a thinner, more efficient zero-water adhesive system8

Unique zero-water formulation9

Image representing ZTlido zero-water adhesive and hydrogel.

>50% thinner

ZTlido is 0.8 mm. Lidoderm 5% is 1.71 mm. See references below. ZTlido is 0.8 mm. Lidoderm 5% is 1.71 mm. See references below.

ZTlido and Lidoderm® are proven to deliver the same dose—but only if 12-hour adhesion is maintained. Consider this: If Lidoderm® doesn't stick, how much lidocaine is really delivered?

Only ZTlido is proven to stay securely attached during 
exercise—rigorously tested in four 30-minute sessions1,4

Image representing the exercise sessions over the 12-hour study period.
  • 30 MINUTES OF EXERCISE (BIKING)

  • ADHESION ASSESSED

0% of ZTlido patches fell off during the entire 12 hours

Study Design1

  • Open-label, randomized pharmacokinetic and adhesion performance study of ZTlido with exercise in 12 healthy adult subjects4

  • Subjects performed 30 minutes on an exercise bike immediately after patch application and at 2.5, 5.5, and 8.5 hours post-patch application

  • Adhesion was assessed immediately after application (0 hour) and at 0.5, 3, 6, 9, and 12 hours

Can other patches keep up with your active patients throughout 
their 12-hour day, especially when they sweat?

Important Safety Information

Contraindications

ZTLIDO is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.

Warnings and Precautions

Accidental exposure can occur even after a ZTLIDO patch has been used. Small children or pets could suffer serious adverse effects from chewing or ingesting a new or used ZTLIDO patch. Store and dispose of patches properly and keep out of reach of children and pets.

Excessive dosing or overexposure to lidocaine can occur. Longer duration of application, application of more than the recommended number of patches, smaller patients, or impaired elimination may all contribute to increased blood concentration levels of lidocaine. If lidocaine overdose is suspected, check drug blood concentration. Management of overdose includes close monitoring, supportive care, and symptomatic treatment.

Cases of methemoglobinemia have been reported with local anesthetic use, although patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, or concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. Signs and symptoms include cyanotic skin discoloration and/or abnormal coloration of the blood and may occur immediately or may be delayed after exposure. Methemoglobin levels may continue to rise leading to more serious central nervous system and cardiovascular adverse effects. Discontinue ZTLIDO and any other oxidizing agents. Depending on severity of the symptoms, patients may respond to supportive care or may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

Application site reactions can occur during or immediately after treatment with ZTLIDO. This may include development of blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or may be the locus of abnormal sensation. These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours. Inform patients of these potential reactions and that severe skin irritation may occur with ZTLIDO if applied for a longer period than instructed.

Hypersensitivity cross-reactions may be possible for patients allergic to PABA derivatives. Manage hypersensitivity reactions by conventional means.

Eye exposure with ZTLIDO should be avoided. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye (eg, eye glasses/eye wear) until sensation returns.

Adverse Reactions

Side effects of ZTLIDO include application site reactions such as, irritation, erythema, and pruritus. These are not all of the adverse reactions that may occur. Please see full Prescribing Information for more information.

Use in Specific Populations

Use of ZTLIDO during lactation should be used with caution as lidocaine is excreted into breast milk. The limited human data with lidocaine in pregnant women are not sufficient to inform drug-associated risk for major birth defects and miscarriage.

To report SUSPECTED ADVERSE REACTIONS, contact SCILEX Pharmaceuticals Inc. at 1-866-SCILEX3 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

REFERENCES

  1. Gudin J, Vought K, Shah M, Patel K. Adhesion characteristics of a topical lidocaine patch 1.8% (36mg). Poster presented at: WIP May 20-23, 2016; New York, NY.

  2. Webster L, Mallick-Searle T, Adler JA, Greuber E, Patel K, Vought K. ZTlido® (lidocaine topical system) 1.8% has superior adhesion compared to generic Mylan lidocaine patch 5%. Poster presented at: PAINWeek; September 3-7, 2019; Las Vegas, NV.

  3. SCILEX Pharmaceuticals Inc. Data on file: SCI-LIDO-ADH-003.

  4. ZTLIDO® (lidocaine topical system) 1.8% [Prescribing Information]. San Diego, CA: SCILEX Pharmaceuticals Inc; 2018.

  5. SCILEX Pharmaceuticals Inc. Data on file: SCI-LIDO-PK-002.

  6. LIDODERM® (lidocaine patch 5%) [Prescribing Information]. Malvern, PA: Endo Pharmaceuticals Inc; 2018.

  7. SCILEX Pharmaceuticals Inc. Data on file: SCI-LIDO-PK-001.

  8. Gudin J, Argoff C, Nalamachu S. 1.8% lidocaine patch (ZTlido): review of a new formulation. Postgrad Med. 2015;127(Suppl):S44-S45.

  9. Gudin J, Backonja M, Nalamachu S. A review of the clinical data on ZTlido (lidocaine patch 1.8%). Postgrad Med. 2015;127(Suppl):S45-S46.

Explore study results that 
raise your expectations

Important Safety Information

Contraindications

ZTLIDO is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.

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