The first and only survey to explore the reality of patch adhesion problems 
was a 2016 Harris Poll of real PHN patients and nurses.1*

Conventional lidocaine patch adhesion 
frustrates patients and nurses1

>00%

of patients say patches detach/move
≥3x during the 12-hour treatment1

What did nurses say about noncompliance?

53% of nurses say patient noncompliance is a challenge to effective PHN treatment. See references below.

of nurses say patient
noncompliance is a challenge
to effective PHN treatment1*

~50% of nurses say poor adhesion contributes to patient noncompliance. See references below.

of nurses say poor adhesion
contributes to patient
noncompliance1*

*This survey, supported by funding from SCILEX Pharmaceuticals Inc., was conducted online by Harris 
Poll from May 2-25, 2016 among patients (n=153) and nurses (n=151). Click here for details.

According to a 2016 Harris Poll among PHN patients and nurses1*:

Tape is not an effective solution to adhesion problems

How do patients really feel about tape?

Patients who used tape reported that this was1*

INCONVENIENT

0%

UNCOMFORTABLE

0%

EXPENSIVE

0%

According to a 2016 Harris Poll among PHN patients and nurses1*:

Inadequate adhesion has multiple negative consequences for patients1*

37% not getting pain relief

37%
are not getting the
pain relief their
doctor prescribed

41% run out of patches

41%
run out of patches
before a refill
is due

49% switch brands

49%
switch brands at
least once due to
adhesion issues

16% stop using the patch

16%
stop using the
patch altogether

80% could not wear the patch

80%
could not wear
their patch during
moderate exercise

*This survey, supported by funding from SCILEX Pharmaceuticals Inc., was conducted online by Harris 
Poll from May 2-25, 2016 among patients (n=153) and nurses (n=151). Click here for details.

At the end of the Harris Poll, ≥80% of patients and nurses 
demanded better
lidocaine patches.1*

Reports to FDA reveal: Ineffective adhesion is a significant problem

(based on objective, compiled data)2

0%

of adverse events relate to patch adhesion for generic lidocaine patches2*

Far greater than other analgesic patch products; 4% for transdermal 
buprenorphine and 6% for transdermal fentanyl2

*Based on adverse events reported to the FDA Adverse Events Reporting System database.

What are the FDA's expectations for adhesion?

When patches lose adherence, patients may get less medication3

Drug delivery depends, in part, on surface area dosed via patch-to-skin contact3

FDA expects the entire patch to stay consistently, uniformly adhered throughout treatment under reasonable conditions, such as3:

Body movements
Changes in temperature
contact with clothing

Body movements

Changes in
temperature

Contact with clothing or bedding

Full adhesion = Expected dose delivered = Therapeutic effect4,5

If the patch you prescribe doesn't stick, does it work?

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. Harris Poll Conducted Online from May 2-25, 2016. PHN Patients & Nurses Study: Final Report. June 9, 2016.

  2. Food and Drug Administration. FDA Adverse Events Reporting System (FAERS) Public Dashboard. Data as of June 30, 2019. Accessed August 19, 2019.

  3. Food and Drug Administration Center for Drug Evaluation and Research. Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs. Guidance for Industry. Draft Guidance. October 2018.

  4. Wokovich AM, Prodduturi S, Doub WH, Hussain AS, Buhse LF. Transdermal drug delivery system (TDDS) adhesion as a critical safety, efficacy and quality attribute. Eur J Pharm Biopharm. 2006;64(1):1-8.

  5. Banerjee S, Chattopadhyay P, Ghosh A, Datta P, Veer V. Aspect of adhesives in transdermal drug delivery systems. Int J Adhes Adhes. 2014;50:70-84.

Uncover the truth about 
patch adhesion problems

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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