May 11, 2009
FDA Approves New Drug to Treat Cushing’s Disease in Dogs
The Food and Drug Administration announced today the approval of Vetoryl (trilostane) Capsules, a new drug for the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism, commonly known as Cushing’s disease. Vetoryl, a new molecular entity, is the first drug approved to treat both pituitary- and adrenal-dependent Cushing’s disease in dogs.
Cushing's disease is a condition that results when the body produces too much cortisol. Cortisol is normally released during times of stress. The level of cortisol produced in dogs with Cushing’s disease is excessive and, if left untreated, becomes incapacitating. Vetoryl acts to block production of cortisol, produced by the adrenal glands. The disease is a complicated and slowly developing one, and the early signs are not always noticed. Symptoms include increased drinking, increased urination, increased appetite, reduced activity, excessive panting, thin or fragile skin, hair loss, recurrent skin infections, and enlargement of the abdomen.
Safety and effectiveness were supported by two field studies in the United Kingdom (U.K.) and one multi-center field study in the United States (U.S.). Success was measured by improvements in both ACTH stimulation test results and clinical signs (appetite, activity, panting, thirst and urination).
The most comment adverse reactions were vomiting, lethargy, diarrhea, and anorexia.
Vetoryl is manufactured by Penn Pharmaceuticals, Wales and distributed by Dechra Veterinary Products, Overland Park, KS.
For additional information, please see http://www.fda.gov/cvm/FOI/141-291o120508.pdf and http://www.fda.gov/consumer/updates/cushings051109.html.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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