FDAnews
www.fdanews.com/articles/85886-valera-completes-study-for-cpp-treatment

VALERA COMPLETES STUDY FOR CPP TREATMENT

April 7, 2006

Valera Pharmaceuticals has announced the successful completion of the active clinical portion of its Phase III study of Supprelin LA, a 12-month implant for treating central precocious puberty (CPP), or the early onset of puberty. This multicenter, open-label study involved 36 patients, primarily female, who ranged in age from 4 to 11 years.

CPP, which is more prevalent in girls, is characterized by the premature development of secondary sexual characteristics due to an increase in secretion of the sex hormones. Additionally, if left untreated, the disorder limits a child from attaining full adult height, thus, resulting in short stature. The standard of care of CPP involves the use of LHRH agonists to suppress this hormonal production to delay the onset of puberty. A treatment regimen can generally run three to five years depending upon the age of a child at the time of diagnosis.