When functional improvement with gabapentinoids isn’t enough

Adding ZTlido enhanced quality of life1,12

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
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.
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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.

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