WASHINGTON, D.C. A synthetic hormone called histrelin acetate was recently approved to treat central, or unexplained, precocious puberty, in which young children develop the sexual characteristics of adolescents.
About 6,000 American children have this condition, with 2,000 new cases diagnosed each year. Histrelin acetate was developed as an orphan product by Ortho Pharmaceuticals of Raritan, N.J., and will be marketed under the brand name Supprelin. Orphan status provides incentives for companies to develop products for use in conditions that afflict fewer than 200,000 people.
In idiopathic central precocious puberty, the most common form of precocious puberty, sexual development occurs without known cause before age 8 in girls and age 9 in boys. (In other forms, factors such as injury may be involved.) These children at first grow faster than normal, but their bones mature only to a certain state, after which no growth occurs, often with failure to reach full adult height. They also tend to have emotional problems commonly associated with adolescence. Their intellectual development, however, matches their actual age.
Supprelin is given at home by a parent as a daily injection, similar to the way insulin is given to juvenile diabetics. The drug causes hormone levels to return to normal, development of sexual characteristics to stop, and skeletal maturation to decelerate. Full adult height then becomes attainable. Physician labeling and a patient information brochure stress the need to give the injection at the same time each day. Directions warns that puberty will not be controlled if the drug is not administered consistently.
Injections can be stopped when a child reaches the appropriate age for onset of puberty.
In clinical trials involving 183 children, the most frequent adverse effects associated with the drug, occurring in 5 percent of patients, were skin reactions at the injection site such as redness, swelling, and itching. In 22% of the girls, light vaginal bleeding occurred during the first month. Other infrequent effects included headache, nausea, and vomiting.
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