Pubdate: Wednesday, January 6, 1999 Source: San Jose Mercury News (CA) Contact: http://www.sjmercury.com/ Copyright: 1999 Mercury Center Author: Marlene Cimons YOUR DOGGY DOWN? GIVE IT A CHILL PILL WASHINGTON -- The Food and Drug Administration on Tuesday approved a new anti-depressant medication -- for dogs. Laugh if you will, but to pet owners who have no choice about leaving their dogs alone and returning home to chaos and debris -- not to mention neighbors furious about prolonged barking -- it can be a serious matter. The drug helps treat separation anxiety -- a serious problem for some dogs whose humans spend too many hours away from home. As such, it could prove a boon in such regions as Silicon Valley, where workers often log long days at the office. The drug is Clomicalm, made by Novartis Animal Health, Greensboro, N.C., a unit of the Swiss health-care giant Novartis AG. Its chemical name is clomipramine hydrochloride -- the basic ingredient of several human antidepressants. ``There are 55 million dogs in the United States, and as many as 10 percent of them have this problem to some degree,'' said Dr. Nicholas Dodman, professor of clinical studies at Tufts University School of Veterinary Medicine. ``It is serious in about 40 percent of these, and they are the ones who really could benefit from this drug.'' But don't blame the dogs, experts say. They are only following what their instincts tell them to do. Dogs are ``pack'' animals by nature and quite social, and often their very survival depends on continued ``bonding'' with the rest of the pack, even if the pack -- in modern times -- consists of a human family, according to animal behavioral experts. ``Being socially ostracized from the pack is like a death sentence,'' said Dr. Stephen Sundlof, head of the FDA's center for veterinary medicine, which has long been responsible for regulating drugs that are used in animals. As a result, these dogs can become naughty when separated from their humans -- barking uncontrollably, chewing, clawing, urinating or otherwise destroying clothes, rugs or furniture -- behavior typically not seen when their owners are present. ``Dogs suffer from the most extraordinary anxiety when they're left, and owners can misinterpret the behavior and then punish the dog,'' said Dodman, the author of ``The Dog Who Loved Too Much.'' The dog's behavior ``is not malicious; they are so attached, and so scared of being left alone that they go almost hysterical.'' Many visits to vet The problem accounts for up to 40 percent of visits to the vet, where behavior modification techniques are usually recommended. When those don't work, owners sometimes become so desperate that they are forced to euthanize their pets. It doesn't matter what kind or size of dog. The problem seems to stem from a troubled past -- a bad early experience, such as coming from a ``poorly run puppy mill'' or pet store, or having had multiple previous owners, Dodman said. As with humans, the drug is supposed to be used in conjunction with behavioral modification therapy. Used alone, the drug won't work, the FDA said. Dogs do not really suffer human-like depression. They do ``act neurotic, show high levels of anxiety and destroy things, but we don't have any indication that dogs suffer depression as we know it,'' said the FDA's Sundlof. ``So this is more of an `anti-anxiety' drug.'' Dodman, in fact, says he likes Prozac even better than Clomicalm -- the two drugs are chemically different -- but Prozac's maker, the Indianapolis-based Eli Lilly and Co., has never gone through the FDA process for doggie approval, Dodman said. Availability uncertain It was not clear Tuesday how soon the drug will become available. The company said it costs about $1 a pill; dogs require one or two pills daily, depending on weight. The drug need not be taken forever; once behavior improves the dog can give up the drug. But it doesn't work for all dogs. In tests, about 160 dogs were given either Clomicalm or a dummy pill in addition to behavior therapy. After a week, 47 percent of the Clomicalm dogs had improved, compared with 29 percent of the dogs getting behavior therapy alone. After two months, 65 percent of the Clomicalm dogs had improved, compared with 55 percent of the placebo dogs. The drug caused mild side effects, including vomiting and diarrhea. The drug, available in Europe since April, may help Novartis grow in the worldwide $3.6 billion market for pet health, analysts said. While that market is a fraction of the one for human treatments, drugmakers are vying for market share as sales of such products grow faster than many traditional drugs. The FDA decision was made public Tuesday along with the approval of a second canine drug, Anipryl, by Pfizer Inc., of Groton, Conn. The latter controls clinical signs of cognitive dysfunction syndrome, an age-related deterioration that results in disorientation, abnormal sleep cycles, and loss of house training, among other things. The Associated Press and Bloomberg News contributed to this report. - --- MAP posted-by: Rolf Ernst