Jun
3
2014

FDA Approves SYNERA® (lidocaine and tetracaine) Topical Patch for Home Use

SOUDERTON, PA, June 3, 2014 Galen US Incorporated today announced that the U.S. Food and Drug Administration (FDA) recently approved a labeling change that allows SYNERA®1 (lidocaine and tetracaine) topical patch to be used at home. SYNERA® is a technological advance that can help prevent needle stick pain associated with superficial IVs and superficial dermatological procedures; it combines two commonly used numbing medications (lidocaine and tetracaine) with warming technology in a simple-to-use peel-and-stick patch. 1

“The SYNERA® patch has been a game changer for our family,” said Kelley Carthey, a Registered Nurse and mother of three. Before we used SYNERA®, my son, who has type 1 diabetes, often feared the needle and pain that accompanied insertion of his continuous glucose monitoring sensor. But now, we use SYNERA® before I need to insert the sensor, and he doesn’t even wince.”

As part of SYNERA®’s availability for home use, Galen US has partnered with Transition Patient Services (TPS) to offer direct-to-patient home delivery of the product through the SYNERA® Now Access Program (SNAP). A health care professional can fax or e-prescribe a prescription for SYNERA® to TPS. The patient will then be contacted by a TPS pharmacist for processing and delivery information. After the call, TPS will mail SYNERA® directly to the patient.

“Pain and discomfort associated with needle stick is real for some patients, especially children. That’s why we’re proud to offer SYNERA® as a local dermal anesthetic to help improve patients’ experiences with superficial IVs and superficial dermatological procedures,” said Andrew Shales, General Manager, Galen US Incorporated. “With our expanded offering of SYNERA® for home use and direct-to-patient home delivery, we hope to provide patients with convenience and reassurance during their treatments.”

KEY FACTS

  •   IV access is rated as one of the most common sources of significant pain and anxiety in pediatric hospitals.2

  •   SYNERA® is faster acting than EMLA®, a local anesthetic comprised of lidocaine and prilocaine in a topical cream, at helping to prevent needle stick pain; SYNERA® works within 20 to 30 minutes of application vs. at least 1 hour of application of EMLA®.1,3,4

  •   SYNERA® is approved for use in adults and children as young as three years old. 1 For more information on SYNERA® and mail order delivery, visit www.synera.com.

Media Contact:

Sarah Cooper 215.928.2184 sarah.cooper@toniclc.com

About Synera® (lidocaine and tetracaine) Topical Patch

SYNERA® is a prescription patch that contains a mixture of lidocaine, tetracaine, and a gentle warming technology that helps prevent pain associated with superficial venous access and superficial dermatological procedures. 1 When applied to intact skin, it helps prevent needle stick pain within 20 to 30 minutes. 3 SYNERA® is approved for use in adults and children as young as three years old. 1

SYNERA® is contraindicated in patients with a known history of sensitivity to lidocaine, tetracaine, local anesthetics of the amide or ester type, hypersensitivity to para-aminobenzoic acid (PABA), or sensitivity to any other component of the product. In clinical studies, some skin reactions occurred at the application site, including redness, blanching, and swelling. These reactions were generally mild and went away without the need for any treatment. Allergic reactions such as hives, difficulty breathing, skin redness or swelling, and shock can occur.

In a randomized, double-blind, placebo-controlled study, 59% of children aged 3 to 17 years reported no pain upon the needle stick compared with only 20% among children who were given a patch with no numbing medications (n=61, P5

About Galen

Established in 1968, Galen is a privately owned pharmaceutical sales and marketing company, headquartered in Craigavon (Northern Ireland), with products in therapy areas including gastroenterology, urology, female health and pain management. As a subsidiary of Galen Limited, Galen US also has a small presence in oncology and plans to continue expanding its portfolio with selected specialty products on an international basis. By combining innovation in product development with competitive pricing, Galen aims to work in partnership with healthcare professionals and patients to create real, long-term value.

Important Safety Information for SYNERA® (lidocaine and tetracaine) Topical Patch

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.

Used SYNERA® patches contain 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, particularly 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.

SYNERA® should be used with caution in patients with a history of methemoglobinemia (refer to full Prescribing Information).

Do not use on mucous membranes or on areas with a compromised skin barrier. Application to broken or inflamed skin may result in toxic blood concentrations of lidocaine and tetracaine.

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.

Simultaneous or sequential application of more than two SYNERA® patches to children is not recommended as it has not been adequately studied.

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 patch removal.

Do not cut or remove the top cover of the patch as this could result in thermal injury.

Please see full SYNERA® Prescribing Information.