Pfizer Animal Health announced today that the Food and Drug Administration (FDA) has approved Slentrol(TM) (dirlotapide) for the safe and effective management of canine obesity, making it the first and only veterinary-approved obesity drug for dogs in the United States.

Slentrol marks a significant milestone in the treatment of canine obesity, an important medical condition with serious health implications. In the United States, about 40 percent of dogs - around 17 million - are considered overweight (5 percent to 20 percent over ideal weight) or obese (20 percent or more over ideal weight), according to 2002 data from the American Veterinary Medical Association.

"Why are 40 percent of dogs in the U.S. overweight or obese? The answer is simple: Too much food and too little exercise," said Claudia A. Kirk, DVM, PhD, Associate Professor of Medicine and Nutrition, College of Veterinary Medicine, University of Tennessee. "In today's hectic world, it's a challenge for many dog owners to find time to ensure their pets get adequate exercise. And in our culture, we often equate food with love - without being aware of potential adverse health consequences. For both pet owners and veterinarians trying to manage a dog's weight, these habits can be a source of genuine frustration."

Slentrol has the potential to revolutionize the approach to weight management in obese dogs by giving veterinarians an additional tool when diet modification and increased exercise are difficult to implement successfully. Slentrol decreases a dog's appetite thereby reducing food intake, making it easier for owners to develop healthier feeding behaviors and attitudes. Slentrol is given once daily as an oral solution, either directly into the mouth or with a small amount of food; the duration of treatment depends on the amount of weight to be lost. A prescription medication, Slentrol will be available only through veterinarians starting this spring. Until then, Pfizer is working to increase awareness of the importance and consequences of obesity in dogs.

Obesity and Its Associated Medical Problems

Research shows that being overweight affects the overall health and well- being of dogs by predisposing them to or exacerbating other potentially serious diseases. Being overweight or obese has been associated with increased risk of serious diseases in dogs such as arthritis, heart disease, respiratory conditions and cancer. Obesity can also worsen the signs associated with pre- existing diseases such as osteoarthritis. In addition, obesity can affect a dog's quality of life by making exercise and play more difficult or even impossible.

Recognition of obesity in the family dog is sometimes difficult, and often owners may think their companion is large boned, has a thick coat or looks best when plump. In addition, weight loss can be difficult for many owners to achieve in their dogs. Diet and exercise - the traditional approaches to weight loss - can be effective if followed. However, many dog owners experience frustration with these measures because of lack of time to exercise their dogs, and difficulty restricting food and treats.

"Obesity is an important medical condition, and research shows that it can be associated with a host of serious health problems including osteoarthritis, cardiovascular disease and respiratory conditions," said George Fennell, Vice President, US Companion Animal, Pfizer Animal Health. "Pfizer Animal Health is committed to working with veterinarians to provide additional tools for weight management in dogs and to helping dogs live healthier, more active lives."

Slentrol: Meets Unmet Medical Needs

Pfizer developed Slentrol in response to the unmet need for a medication to help veterinarians and pet owners dependably manage canine obesity in a comprehensive program that includes healthy diet and appropriate exercise. Pfizer veterinary medical scientists have spent more than five years conducting the studies leading to the approval of Slentrol. In clinical trials, Slentrol was shown to be safe, effective, and dependable, producing consistent results in a wide range of dog breeds.

Slentrol should not be used in cats, dogs receiving long-term corticosteroid therapy or dogs with liver disease. While Slentrol is well- tolerated, the most common side effect is vomiting, and dogs may experience diarrhea, lethargy or anorexia. Dog owners will be advised to call their veterinarian if side effects last for two days. Slentrol is not for use in humans under any circumstances.

"Veterinarians will now have the additional option of using Slentrol in conjunction with diet and exercise," said S. Kristina Wahlstrom, VMD, MS, Pfizer Animal Health. "Because many dog owners don't recognize that their pets are overweight or obese, the best thing for owners to do is talk to their veterinarians about the proper weight for their particular dog."

With 2005 sales of $2.2 billion, Pfizer Animal Health is a global leader in discovering, developing and marketing medicines and vaccines for companion animals and livestock, including beef and dairy cattle and swine.

Pfizer Animal Health