Puberty hormone suppressor

From WikiCover

On June 25, 2007, Indevus Pharmaceuticals announced the launch and availability of Supprelin LA (histrelin acetate) subcutaneous implant, 50mg, for the treatment of children with Central Precocious Puberty (CPP), the premature development of characteristics that normally occur during puberty. In females, premature development is usually defined as earlier than eight years of age, and in males, as earlier than nine years of age. Children with CPP have an increased likelihood of psycho-social problems and also show significantly advanced bone age that can lessen their ability to attain full adult height.

Supprelin LA was approved by the FDA on May 3, 2007 and is a once-yearly implant which utilizes the company's patented Hydron implant technology. The implant is inserted subcutaneously in the inner aspect of the upper arm and is specifically designed to provide a continuous release over twelve months of approximately 65mcg/day of the gonadotropin releasing hormone (GnRH) analog histrelin.

FDA approval was based on the review of data from clinical studies conducted in children four to eleven years of age. A total of forty-seven children, forty-four female and three male, were studied in two trials of over nine to eighteen months.