FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 
                                               
T99-2                           Print Media:         301-827-6242
January 5, 1999                 
                                Consumer Inquiries:  888-INFO-FDA

FDA APPROVES FIRST BEHAVIORAL DRUGS FOR DOGS

FDA has approved two drugs to treat two different behavioral problems affecting some dogs -- Clomicalm Tablets (clomipramine hydrochloride) to be used as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than six months of age, and Anipryl Tablets (selegiline hydrochloride, L-deprenyl hydrochloride) to control the clinical signs associated with canine Cognitive Dysfunction Syndrome (CDS).

Separation anxiety is a complex behavior disorder displayed when the owner or someone the dog is attached to leaves the dog. Dogs with separation anxiety may exhibit one or more of the following symptoms: barking, destructive behavior, excessive salivation, and inappropriate elimination.

Proper recognition of clinical signs, which comes from compiling a complete patient history and assessment of the dog's household environment, is essential to accurately diagnose and treat separation anxiety.

In clinical trials, Clomicalm Tablets, when used with behavior modification, were shown to reduce the signs of separation anxiety and increase the rate of improvement when compared to behavior modification alone.

Anipryl Tablets can control the clinical signs associated with CDS, an age-related deterioration typified by multiple cognitive impairments which affect the dog's ability to function normally. Behavioral changes associated with CDS include disorientation, decreased activity level, abnormal sleep wake cycles, loss of house training, decreased or altered responsiveness to family members, and decreased or altered greeting behavior.

In clinical trials, Anipryl was shown to be effective in controlling clinical signs associated with CDS. However, onset, duration and magnitude of response varied with individual dogs.

The diagnosis of CDS in dogs is a diagnosis of exclusion, based on thorough behavioral and medical histories, in conjunction with appropriate testing and diagnosis. Periodic patient monitoring to evaluate the response and tolerance to the drug and for the presence of concurrent or emergent disease is recommended.

Clomicalm Tablets will be sold by Novartis Animal Health US, Inc. of Greensboro, NC. Anipryl will be sold by Pfizer Animal Health, Inc. of Exton, Pa. Both will be available in tablet form and only on the order of a veterinarian.

(Hypertext correction made 1-11-1999 by clb)

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