The FDA approved a labeling change that allows Galen US Incorporated's Synera (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.

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."

In a randomized, double-blind, placebo-controlled study, 59 percent of children aged three to 17 years reported no pain upon the needle stick compared with only 20 percent among children who were given a patch with no numbing medications (n=61, P<0.001).

Synera has been shown to be 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 one hour of application of Emla. Synera is approved for use in adults and children as young as three years old.

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.