SYNERA®: Superficial Venous Access Clinical Trials

Superficial Venous Access Clinical Trials

In a randomized (2:1), double-blind, placebo-controlled study in children aged 3 to 17 years^1,2:

Patients aged 3 to 17 years (N=64; 61 patients evaluable for efficacy) used SYNERA^® (lidocaine 70 mg and tetracaine 70 mg) topical patch, or an identical self-heating placebo patch for 20 minutes prior to venipuncture. The 3- to 6-year-olds rated their pain using a 6-photograph Oucher scale. The 7- to 17-year-olds used an 11-point Oucher scale with faces and numbers.

• In the 7-to-17-year-old group, the results were considered to be clinically meaningful, but treatment differences in this group did not reach statistical significance versus placebo²

Median Oucher Scores from the same study²:

	•	Ages 3-6: SYNERA=0; placebo=80 (P<0.001)
	•	Ages 7-17: SYNERA=7.5; placebo=50 (P<0.159)

In the Same Study, SYNERA^® Prevented Pain in More Children¹*

* Investigators independently rated analgesia on a 4-point scale ranging from no pain to severe pain. Children aged 3 to 6 years used a 6-photograph Oucher scale. Older children (7 to 17 years) used an 11-point Oucher scale with faces and numbers.

In this study:

•	No serious adverse events (SAEs) reported. Only transient, mild application site reactions were observed
	–	Erythema incidences for SYNERA versus placebo were 51% and 43%; edema incidences were 0% and 10%, respectively
•	In all clinical studies, the most common local reactions were erythema (71%), blanching (12%), and edema (12%); these reactions were generally mild, resolving spontaneously soon after treatment ³


	Before using SYNERA, review the full prescribing information


	Important Safety Information SYNERA^® topical patch is indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures. SYNERA^® is contraindicated in patients with a known history of sensitivity to lidocaine, tetracaine, local anesthetics of the amide or ester type, or any other component of the product and in patients with para-aminobenzoic acid (PABA) hypersensitivity. Keeping a patch on longer than recommended or applying multiple patches simultaneously or sequentially could result in systemic absorption sufficient to result in serious adverse effects that are typical of drugs in this class. Even a used SYNERA^® patch contains a large amount of lidocaine and tetracaine (at least 90% of the initial amount). Chewing or ingesting a new or used SYNERA^® patch may result in serious adverse effects. Store and dispose of SYNERA^® out of the reach of children and pets. SYNERA^® should be used with caution in patients who may be more sensitive to the systemic effects of lidocaine and tetracaine, including the acutely ill, the debilitated, and those with compromised hepatic function. Patients with severe hepatic disease or pseudocholinesterase deficiency are at greater risk of developing toxic plasma concentrations. Allergic or anaphylactoid reactions (urticaria, angioedema, bronchospasm, and shock) to the active or inactive components of SYNERA^® can occur and should be managed by conventional means. Avoid contact of SYNERA^® with the eyes due to potential irritation or abrasion. If contact occurs, immediately wash out the eye with water or saline, and protect it until sensation returns. Safety and effectiveness of SYNERA^® have been established in patients 3 years and older. Lidocaine has been shown to inhibit viral and bacterial growth. The effect of SYNERA^® on intradermal injections of live vaccines has not been determined. The heating component contains iron powder, and the patch must be removed before magnetic resonance imaging. SYNERA^® may lead to diminished or blocked sensation in the treated skin; therefore, patients should avoid inadvertent trauma (rubbing, scratching, or exposure to heat or cold) before complete sensation returns. SYNERA^® should be used with caution in patients receiving class I antiarrhythmics and/or other local anesthetics, because the systemic toxic effects may be additive and potentially synergistic with lidocaine and tetracaine. In clinical studies, the most common local reactions were erythema (71%), blanching (12%), and edema (12%); these reactions were generally mild, resolving spontaneously soon after treatment. Do not cut or remove the top cover of the patch as this could result in thermal injury. SYNERA^® is not for home use by patient. Please see accompanying full Prescribing Information before using SYNERA.

References:

1. Sethna NF, Verghese ST, Hannallah RS, Solodiuk JC, Zurakowski D, Berde CB. Anesthesiology. 2005;102:403-408.

2. Data on file, ZARS Pharma Inc.

3. SYNERA® Prescribing Information.