Indevus Pharmaceuticals Inc announced positive results of the ongoing phase III extension study of Supprelin LA (histrelin acetate), the only once-yearly subcutaneous implant for the treatment of central precocious puberty or early onset puberty, at the Lawson Wilkins Paediatric Endocrine Society (LWPES) Annual Meeting.
This study evaluated the two-year safety and efficacy of Supprelin LA in children who received a second implant following an initial year of therapy. The study found that Supprelin LA demonstrated continued profound hormone suppression with no escapes (breakthrough of hormones) and led to continued decreases in rates of growth, skeletal maturation and body mass index at 24 months compared to 12 months.
"This study confirms that Supprelin LA maintains remarkable suppression of peak hormone and sex steroid levels for two years in children with central precocious puberty and that the removal of the first implant and insertion of the second does not influence efficacy," said Gad Kletter, MD, Head of Paediatric Endocrinology, Swedish Medical Centre, Seattle, WA. "While the frequent dosing of traditional injections may lead to issues with long-term compliance, Supprelin LA offers patients, families and physicians a truly sustained treatment option that only requires action once a year".
"Central precocious puberty can be a devastating condition physically, psychologically and socially and is extremely difficult to manage," stated Bobby Sandage, Jr., Ph.D., executive vice president, research and development and chief scientific officer, Indevus Pharmaceuticals. "We are encouraged by these recent findings and hope they provide an added level of comfort for patients and families using or considering using Supprelin LA for the treatment of central precocious puberty".
Supprelin LA was approved by the US Food and Drug Administration (FDA) on May 3, 2007 and is a once-yearly implant which utilizes the Company's patented Hydron Polymer Technology.