References

Rehm S, Binder A, Baron R. Post-herpetic neuralgia: 5% lidocaine medicated plaster, pregabalin, or a combination of both? A randomized, open, clinical effectiveness study. Curr Med Res Opin. 2010;26(7):1607-1619. doi: 10.1185/03007995.2010.483675
ZTLIDO® (lidocaine topical system) 1.8%. Prescribing information. SCILEX Pharmaceuticals; April 2021.
Johnson P, Becker L, Halpern R, Sweeney M. Real-world treatment of post-herpetic neuralgia with gabapentin or pregabalin. Clin Drug Investig. 2013;33(1):35- 44. doi: 10.1007/s40261-012-0030-4
Chincholkar M. Gabapentinoids: pharmacokinetics, pharmacodynamics and considerations for clinical practice. Br J Pain. 2020;14(2):104-114. doi: 10.1177/2049463720912496
Backonja M, Glanzman RL. Gabapentin dosing for neuropathic pain: evidence from randomized, placebo-controlled clinical trials. Clin Ther. 2003;25(1):81-104. doi: 10.1016/s0149-2918(03)90011-7
Rice ASC, Maton S; Postherpetic Neuralgia Study Group Gabapentin in postherpetic neuralgia: a randomised, double blind, placebo controlled study. Pain. 2001;94(2):215-224. doi: 10.1016/S0304-3959(01)00407-9
Wiffen PJ, Derry S, Bell RF, et al. Gabapentin for chronic neuropathic pain in adults. Cochrane Database Syst Rev. 2017;6(6):CD007938.
doi: 10.1002/14651858. CD007938.pub4
Neurontin (gabapentin). Prescribing information. Pfizer; 2021.
Lyrica (pregabalin) capsules, CV. Prescribing information. Parke-Davis; 2020.
Rowbotham M, Harden N, Stacey B, Bernstein P, Magnus-Miller L. Gabapentin for the treatment of postherpetic neuralgia: a randomized controlled trial. JAMA. 1998;280(21):1837-(18)42. doi: 10.1001/jama.280.21.1837
Geha PY, Baliki MN, Chialvo DR, Harden RN, Paice JA, Apkarian AV. Brain activity for spontaneous pain of postherpetic neuralgia and its modulation by lidocaine patch therapy. Pain. 2007;128(1-2):88-100. doi: 10.1016/j.pain.2006.09.014
SCILEX Pharmaceuticals Inc. Data on file.
Binder A, Rogers P, Hans G, Baron R. Impact of topical 5% lidocaine-medicated plasters on sleep and quality of life in patients with postherpetic neuralgia. Pain Manag. 2016;6(3):229-239. doi:10.2217/pmt-2015-0010
Rampakakis E, Ste-Marie PA, Sampalis JS, et al. Real-life assessment of the validity of patient global impression of change in fibromyalgia. RMD Open. 2015;1(1):e000146. doi:10.1136/rmdopen-2015-000146
Gudin J, Webster LR, Greuber E, Vought K, Patel K, Kuritzky L. Open-label adhesion performance studies of a new lidocaine topical system 1.8% versus lidocaine patches 5% and lidocaine medicated plaster 5% in healthy subjects. J Pain Res. 2021;14:513-526. doi: 10.2147/JPR.S287153
Lidoderm® (Lidocaine Patch 5%). Prescribing information. Endo Pharmaceuticals, Inc.; November 2018.
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.
Fudin J, Wegrzyn EL, Greuber E, Vought K, Patel K, Nalamachu S. A randomized, crossover, pharmacokinetic and adhesion performance study of a lidocaine topical system 1.8% during physical activity and heat treatment in healthy subjects. J Pain Res. 2020;13:1359-1367. doi: 10.2147/JPR.S238268
Vought K, Greuber E, Patel K, Argoff C, Lissin D. A randomized, crossover, adhesion performance and pharmacokinetic study of a lidocaine topical system under conditions of water exposure in healthy subjects. J Pain Res. 2021;14:2459-2467. doi:10.2147/JPR.S323789

ZTLIDO is indicated for relief of pain associated with post-herpetic neuralgia (PHN) in adults.
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.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION
ZTLIDO is indicated for relief of pain associated with post-herpetic neuralgia (PHN) in adults.

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. If application site reactions occur while the topical system is being worn, advise the patient to remove ZTLIDO and not to reapply until skin reactions subside.

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, eyeglasses/eyewear) 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.