FDA News

Lilly Receives FDA Approval For Antidepressant For Dogs

(April 25, 2007)-- Eli Lilly and Company announced it has received approval from the FDA to market Reconcile (fluoxetine hydrochloride), the first selective serotonin reuptake inhibitor (SSRI) class of antidepressants approved by the FDA for treatment of canine separation anxiety in conjunction with behavior modification training. Reconcile is the first Lilly product approved by the FDA for dogs and is now available to U.S. veterinarians.

"Lilly research shows that 10.7 million, or up to 17 percent of U.S. dogs suffer from separation anxiety," said Steve Connell, D.V.M., manager of technical, academic and consumer services for companion animal health at Lilly. "We're thrilled that our first product for dogs can help restore the human-pet bond, which can be compromised when dogs suffer from separation anxiety."

Reconcile(TM) is a once-daily, chewable, flavored tablet that may be prescribed by a veterinarian in weight-specific doses for use in conjunction with behavior modification training to treat canine separation anxiety. The drug is proven safe for dogs and puppies 6 months or older.

In field studies of approximately 600 dogs, 73 percent of dogs receiving Reconcile showed improvement in separation anxiety-related behavior within eight weeks when compared with dogs receiving behavior modification training alone. Within one week of starting Reconcile treatment and behavior modification training, 42 percent of dogs showed improvement. During trials, the most common adverse reactions to Reconcile were calm or lethargy, reduced appetite, vomiting, shaking, diarrhea, restlessness, excessive vocalization, aggression and -- in infrequent cases -- seizures.

Reconcile allows dogs to be more receptive to your training to help with anxiety.

Canine separation anxiety is a prevalent and often misunderstood behavior problem, according to Connell. It amounts to undesirable behavior that occurs when the dog is left alone even for short periods of time. The resulting anxiety may cause the dog to engage in inappropriate behavior, such as destruction, excess vocalization and inappropriate elimination. Anorexia and depression also may be observed in some cases. "Your family veterinarian may recommend certain tests before diagnosing separation anxiety," Connell added. "Such tests are used to rule out other potential physiological causes of inappropriate behavior."

For dogs affected by separation anxiety, Reconcile(TM) reduces inappropriate behaviors, minimizes the pet's distress and increases receptivity to a simple training plan called the BOND(TM) modification training plan.

The BOND behavior modification program is an easy-to-implement, at-home training plan developed by Lilly and a team of veterinary behaviorists as well as veterinarians. The simple plan allows dog owners to take an active role in the treatment of their pet's separation anxiety to help restore the human-pet bond. Dog owners whose veterinarians have prescribed Reconcile(TM) receive educational materials to enable them to follow an easy four-step training plan to reinforce positive pet behavior which helps to reduce or eliminate inappropriate responses to anxiety. Components include a take-home DVD, printed materials and in-home reminders so the whole family can reinforce behavior modification training for the dog.

Debra F. Horwitz, D.V.M., and a diplomate of the American College of Veterinary Behaviorists, was among the veterinary behaviorists involved in developing the BOND(TM) program. "Learning and memory are important in the formation and maintenance of anxieties," said Horwitz. "Decreasing anxiety can help pets learn and, through training, they can learn new responses to stimuli that have triggered separation anxiety in the past. The development of the BOND(TM) behavior modification plan is an important complement to Reconcile(TM) in the treatment of separation anxiety."

Share or bookmarklet this web page at: