Galen US Incorporated today announced that the U.S. Food and Drug Administration (FDA) recently approved a labeling change that allows 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.
"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."
- IV access is rated as one of the most common sources of significant pain and anxiety in pediatric hospitals.
- 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®.
- SYNERA® is approved for use in adults and children as young as three years old.
Source: Galen US Incorporated