United States

SIMBADOL, the First and Only FDA-Approved Buprenorphine for Cats, Is Now Available from Zoetis

24-hour surgical pain control addresses growing need for feline pain management

FLORHAM PARK, N.J. – August 18, 2015 – Zoetis Inc. today announced that SIMBADOLTM (buprenorphine injection) is available for clinic use with feline patients. SIMBADOL is the only buprenorphine approved by the U.S. Food and Drug Administration (FDA) for cats and offers 24 hours of postoperative pain control in one dose. Zoetis acquired the product as part of its purchase of the assets of Abbott Animal Health in February 2015.

New pain management guidelines developed by the American Animal Hospital Association (AAHA) and the American Association of Feline Practitioners (AAFP)1 as well as various new pain evaluation studies 2,3,4 have brought increased attention to feline surgical pain management.

“Cats are challenging because they tend to obscure the behaviors associated with pain,” said Ralph Harvey, DVM, MS, DACVAA, director of anesthesia and pain management services in the Department of Small Animal Clinical Sciences at the University of Tennessee College of Veterinary Medicine.5  “Advances are being made to aid in accurately evaluating feline pain, and we now have an analgesic medication indicated specifically for cats.”

Several recently published studies have evaluated various methods to assess pain in cats and have identified specific physiological and behavioral changes including a cat’s facial expression as a means to assess pain in cats.2,3,4

“SIMBADOL is a wonderful addition to our feline surgical protocol because it is consistent, reliable and provides 24-hour duration of action for overnight pain management,” Dr. Harvey added. “Owners have always presumed that we would be managing their pets’ pain. Now we have the tools and medications to better meet their expectations.”

About SIMBADOL
In two large clinical studies, SIMBADOL provided effective analgesia with an adequate adverse event profile in cats undergoing both soft tissue and orthopedic surgeries. The majority of adverse events were mild in severity and similar to the placebo group in frequency.6 In a separate safety study, SIMBADOL was well tolerated at up to five times the label dose for up to nine days.7

SIMBADOL is administered as a subcutaneous injection and is indicated for the control of postoperative pain associated with surgical procedures in cats. The first dose is given one hour prior to surgery with repeat administration of an additional two doses for a total of 72 hours of pain control. It is available in a multi-use 10 ml vial that provides approximately 15 injections and can be stored at room temperature, offering 28 days shelf-life once broached. For more information or to place an order, speak with your Zoetis representative, call Customer Service at 1-888-ZOETIS1 (963-8471), or visit www.Simbadol.com.

IMPORTANT SAFETY INFORMATION

WARNINGS, PRECAUTIONS and CONTRAINDICATIONS: Due to serious human safety and abuse concerns, including physical or psychological dependence, life-threatening respiratory depression and additive CNS depressant effects, read the full prescribing information before using this drug, including the complete Boxed Warning. Not for use in humans. Hospital staff should be trained in the handling of potent opioids and should avoid accidental exposure. For subcutaneous (SQ) injectable use in cats. Opioid excitation has been observed up to 8 hours after anesthetic recovery. Use with caution in cats with impaired hepatic function. SIMBADOL has not been evaluated in breeding, pregnant or lactating cats, in cats younger than 4 months of age or moribund cats. Do not use in cats with known hypersensitivity to buprenorphine hydrochloride or any of the components of SIMBADOL, or known intolerance to opioids.

ADVERSE REACTIONS
: In two controlled field studies, the most frequent adverse reactions with SIMBADOL were hypotension, tachycardia, hypothermia, hyperthermia, hypertension, anorexia, and hyperactivity. Less frequent but serious adverse reactions included two deaths following apnea and two reports of presumptive post-anesthetic cortical blindness. See the full prescribing information for a complete list and additional details of adverse reactions for each field study.

See full Prescribing Information, including the complete Boxed Warning for human safety.

About Zoetis
Zoetis (zô-EH-tis) is the leading animal health company, dedicated to supporting its customers and their businesses. Building on more than 60 years of experience in animal health, Zoetis discovers, develops, manufactures and markets veterinary vaccines and medicines, complemented by diagnostic products and genetic tests and supported by a range of services. In 2014, the company generated annual revenues of $4.8 billion. With approximately 10,000 employees worldwide at the beginning of 2015, Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals with sales of its products in 120 countries. For more information, visit www.zoetisUS.com.

For Further Information,Contact:

Colleen White
Zoetis
973-822-7203
colleen.white@zoetis.com

Julie Lux
Archer Malmo
901-500-7063
jlux@archermalmo.com

1 American Animal Hospital Association. 2015 AVMA/AAFP Pain Management Guidelines for Dogs and Cats. https://www.aaha.org/professional/resources/pain_management.aspx#gsc.tab=0.Accessed July 28, 2015.
2 Holden E, Calvo G, Collins M, Bell A, Reid J, Scott EM, Nolan AM. Evaluation of facial expression in acute pain in cats. J Small Anim Pract. 2014;55(12):615-621. doi: 10.1111/jsap.12283. Accessed June 22, 2015.
3 Brondani JT, Luna SP, Padovani CR. Refinement and initial validation of a multidimensional composite scale for use in assessing acute postoperative pain in cats. Am J Vet Res. 2011;72(2):174-183.
4 Calvo G, Holden E, Reid J, et al. Development of a behaviour-based measurement tool with defined intervention level for assessing acute pain in cats. J Small Anim Pract. 2014;55(12):622-629.
5 Dr. Ralph Harvey is a consultant to Zoetis.
6 SIMBADOL Freedom of Information Summary NADA 141-434; July 18, 2014.
7 SIMBADOL Freedom of Information Summary NADA 141-434; July 18, 2014.