When functional improvement with gabapentinoids isn’t enough

Adding ZTlido enhanced quality of life^1,12

Clinical Study Data

Real-World Data

After 8 weeks of combination therapy with ZTlido, most patients rated their quality of life as
"much" or "very much" improved.¹

Study design: Phase 3, two-stage adaptive, randomized, open-label study (N=98) in patients with PHN; chart shows patients treated with pregabalin alone, then in combination with a ZTlido equivalent.^1†

Study design¹

A phase 3, two-stage randomized, open-label study comparing ZTlido* with pregabalin monotherapy in 98 patients with PHN^†

Stage 1:

Patients randomized to 4 weeks’ monotherapy with either

Pregabalin titrated to effect
- All patients received 150 mg/day in week 1 and 300 mg/day in week 2
- At the end of week 2, dose increased to 600 mg/day in
  patients with insufficient relief (NRS >4)
ZTlido: up to 3 patches/day (12 hours on, 12 hours off)

STAGE 2:

Sufficiently treated with monotherapy (NRS ≤4), continued the same agent for 8 weeks
Insufficiently treated with monotherapy (NRS >4), received both drugs in combination for 8 weeks
- Results presented from patients insufficiently treated with pregabalin monotherapy

AE=adverse event; NRS=numeric rating scale; PGIC=Patient Global Impression of Change; PHN=post-herpetic neuralgia; QoL=quality of life. ^*ZTlido equivalent; "ZTlido equivalent" connotes that study was performed using bioequivalent lidocaine 5% patch. ^†Concomitant analgesics not permitted, except rescue acetaminophen (≤2 g/day). ^‡11-point NRS (0=no pain to 10=pain as bad as you can imagine).

*PGIC = the self-report measure Patient Global Impression of Change. PGIC reflects a patient’s belief about the overall change in symptoms with treatment. PGIC is a 7-point scale depicting a patient’s rating of overall improvement. Patients rate their change as ‘‘very much improved,’’ ‘‘much improved,’’ ‘‘minimally improved,’’ ‘‘no change,’’ ‘‘minimally worse,’’ ‘‘much worse,’’ or ‘‘very much worse.’’^1,14
^†ZTlido equivalent. "ZTlido equivalent" connotes that study was performed using bioequivalent lidocaine 5% patch.

Real-world results 2022-2023¹²

Real-World Experience: The ZTlido Survey (n = 100) was conducted from 2022-2023 by Scilex Pharmaceuticals. The objective was to assess the real-world impact of adding ZTlido to gabapentinoids in patients with inadequate pain relief.

When used correctly (patients who reported using ZTlido every day/almost every day), patients experienced full therapeutic benefit of ZTlido:

ZTlido Patient Survey¹²

Suggested patient selection criteria:

Physicians were encouraged to enroll patients with chronic neuropathic pain of PHN who had inadequate pain relief after being titrated up to a steady dose* of a gabapentinoid. Patients ranged in age from 26-74 and included 27 males and 73 females.

Treatment:

Patients were prescribed up to 3 ZTlido patches/day. They were instructed not to use ZTlido PRN, but to wear ZTlido every day for the 30-day treatment period in order to receive the full therapeutic benefit of the product.

Methods:

Patients received the ZTlido Patient Survey after using ZTlido for at least 3 weeks (Day 21 of their co-pay card activation). Data were derived from those patients who reported using ZTlido every day/almost every day (n=100).

*Steady dose defined as the dose patients have been able to reach and remain on after titration.
PHN=post-herpetic neuralgia: GI=gastrointestinal.

When pain interferes with daily life of patients on gabapentinoids* Improved sleep by night allows for improved function by day¹³

Break the vicious cycle of chronic pain with ZTlido^†

Study design: An 8-week, open-label arm of a double-blind, controlled study to determine the impact of a ZTlido equivalent^†, on sleep (CPSI), QoL, and pain in 265 patients with PHN. Those patients on gabapentinoids (41%) were allowed to remain on treatment. Patients were prescribed up to 3 patches a day. CPSI was evaluated at 4 weeks.¹³
CPSI=Chronic Pain Sleep Inventory; PHN=post-herpetic neuralgia; QoL=quality of life; SF-36=Short-Form 36; SF-MPQ=Short-Form McGill Pain Questionnaire.

Study design¹³

An 8-week, open-label arm of a double-blind, controlled study to determine the impact of ZTlido equivalent* on sleep, quality of life, and pain in 265 patients with PHN.

Additional study results:

After 8 weeks of ZTlido treatment, patients experienced:

Improved sleep parameters (CPSI) and perception of patients' QoL (SF-36)
Reduced pain burden as assessed by SF-MPQ:
- Approximately 50% of patients achieved at least `moderate` pain relief

^*ZTlido equivalent; "ZTlido equivalent" connotes that study was performed using bioequivalent lidocaine 5% patch.
^†11-point NRS (0=no pain to 10=pain as bad as you can imagine).
CPSI=Chronic Pain Sleep Inventory; PHN=post-herpetic neuralgia; QoL=quality of life; SF-36=Short-Form 36; SF-MPQ=Short-Form McGill Pain Questionnaire.

*Patients on gabapentinoids (41%) were allowed to continue with treatment while taking a ZTlido equivalent.
^†ZTlido equivalent. "ZTlido equivalent" connotes that study was performed using bioequivalent lidocaine 5% patch.
^‡Sleep measured by CPSI (usually/always); function measured by SF-36.

Learn how ZTlido works

LEARN MORE

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.