ZTlido Efficacy

For patients suffering from chronic neuropathic pain, gabapentinoids typically do not provide enough pain relief1,2

Titration to an effective dose is often unattainable3

Gabapentin
Pregabalin
Only 14%
of gabapentin patients reach the minimally effective dose of 1800 mg/day due to dose-limiting side effects3-10*
Takes 10 weeks, on average3

Supporting evidence3

Study Design

  • A retrospective analysis of a claims database from a national US health plan
    • Covered 26.9 million adults during the study period
  • Study population: health plan members with PHN initiating treatment with gabapentin or pregabalin
    • Claims data available for 12 months after initiation

Results

  • Identified 1645 patients with PHN receiving gabapentin (826 mg mean daily dose) or pregabalin (187 mg mean daily dose)
Gabapentin
Took 10 weeks, on average
14%
of patients treated with gabapentin reached 1800 mg/day
  • Of the 37% who added a therapy to pregabalin, 57% added an opioid
Pregabalin
Took 9.2 weeks, on average
27%
of patients treated with pregabalin reached ≥300 mg/day
  • Of the 31% who added a therapy to pregabalin, 58% added an opioid
PHN = post-herpetic neuralgia.
Patient function and quality of life can be negatively impacted when pain relief is not enough
Only 27%
of pregabalin patients reach the minimally effective dose of ≥300 mg/day due to dose-limiting side effects3,4,9*
Takes 9.2 weeks, on average3

Supporting evidence3

Study Design

  • A retrospective analysis of a claims database from a national US health plan
    • Covered 26.9 million adults during the study period
  • Study population: health plan members with PHN initiating treatment with gabapentin or pregabalin
    • Claims data available for 12 months after initiation

Results

  • Identified 1645 patients with PHN receiving gabapentin (826 mg mean daily dose) or pregabalin (187 mg mean daily dose)
Gabapentin
Took 10 weeks, on average
14%
of patients treated with gabapentin reached 1800 mg/day
  • Of the 37% who added a therapy to pregabalin, 57% added an opioid
Pregabalin
Took 9.2 weeks, on average
27%
of patients treated with pregabalin reached ≥300 mg/day
  • Of the 31% who added a therapy to pregabalin, 58% added an opioid
PHN = post-herpetic neuralgia.
*The mean daily dose of pregabalin was 187.08 ± 102.88
Of those who added a therapy to pregabalin, 58% added an opioid3
But adding oral analgesics to boost gabapentinoids comes with baggage3,6-7
*1800 mg/day was the minimally effective dose in clinical trials (doses up to 3600 mg/day may be required in some patients).6-7

When pain relief with gabapentinoids isn't enough Adding ZTlido doubles pain relief without the baggage of oral analgesics1

An 8-week trial using up to 3 patches daily, (to ensure adequate coverage of the painful area) is recommended to achieve similar results1
An 8-week trial using up to 3 patches daily, (to ensure adequate coverage of the painful area) is recommended to achieve similar results1

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).

PHN=post-herpetic neuralgia; SF-MPQ=Short-Form McGill Pain Questionnaire; VAS=visual analog scale.
*SF-MPQ pain intensity was assessed on a VAS of 0 (no pain) to 100 (worst possible pain).
ZTlido equivalent.
"ZTlido equivalent" connotes that study was performed using bioequivalent lidocaine 5% patch.
 

IMPORTANT SAFETY INFORMATION
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.

TESTIMONIAL

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Hear what your peers are saying about ZTlido

One of my goals as a pain doctor is to be able to improve patient function. To be able to write a medication that’s going to help them do things that they weren’t able to do, without being limited by side effects, is something that’s really important to me.

Dr. Caitlin Innerfield
Interventional Pain Specialist
ReclaimAbility Pain Services

How to optimize patient success with ZTlido

Ensure adequate coverage of the painful area

When you need more than 1 patch to cover the painful area. ZTlido is indicated for up to 3 patches a day
(12 hours on /12 hours off delivers 24 hours of pain control).1,2

Use daily for at least 8 weeks

ZTlido has a dual-effect mechanism of action—peripheral, as a well as central—with continued daily use.11
To get the full therapeutic effect, ZTlido must be used as prescribed every day (not PRN) for at least 8 weeks.

Do not allow substitutions

There’s no generic substitution for ZTlido.

ZTlido is not AB-rated/ interchangeable with other lidocaine patches.11

Provide co-pay card and track progress

Give every patient a ZTlido patient brochure, which includes a co-pay card and a symptom/compliance tracker.

Learn how ZTlido improves quality of life

LEARN MORE