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"This study confirms that SUPPRELIN LA maintains remarkable suppression ofpeak hormone and sex steroid levels for two years in children with centralprecocious puberty and that the removal of the first implant and insertion ofthe second does not influence efficacy," said Gad Kletter, MD, Head ofPediatric Endocrinology, Swedish Medical Center, Seattle, WA. "While thefrequent dosing of traditional injections may lead to issues with long-termcompliance, SUPPRELIN LA offers patients, families and physicians a trulysustained treatment option that only requires action once a year."
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"Central precocious puberty can be a devastating condition physically,psychologically and socially and is extremely difficult to manage," statedBobby Sandage, Jr., Ph.D., Executive Vice President, Research and Developmentand Chief Scientific Officer, Indevus Pharmaceuticals. "We are encouraged bythese recent findings and hope they provide an added level of comfort forpatients and families using or considering using SUPPRELIN LA for thetreatment of central precocious puberty."
About the Study
The study was a multi-center, prospective extension study following aninitial 12 month Phase III trial. Thirty-one patients (29 girls and 2 boys)aged 5 to 11 years opted to have a second implant placed. At all sites, apediatric surgeon removed the first implant and inserted a second during thesame procedure. Clinic visits occurred every six months, while GnRHastimulation tests were performed at one and 12 months following placement ofthe second implant and bone ages were obtained annually. Primary outcome waspeak luteinizing hormone (LH), which helps regulate the menstrual cycle andegg production in females, after GnRHa stimulation test.
Peak LH declined from 0.92 +/- 0.58 mIU/mL at 12 months to 0.51 +/- 0.33mIU/mL at 24 months (p< 0.0001) in the naive group and from 0.74 +/- 0.50mIU/mL at 12 months to 0.45 +/- 0.35 mIU/mL at 24 months (p = 0.0005) inpreviously treated subjects. Growth velocity SD score decreased from -0.42+/- 2.40 during the first year to -1.75 +/- 3.05 during the second (p =0.0033). Mean BMI percentile declined from 90.56 +/- 14.98 at 12 months to88.00 +/- 19.63 at 24 months (p=0.0389). Continued prospective follow upstudies are needed to investigate long term effects of the SUPPRELIN LAsubcutaneous implant for the treatment of central precocious puberty.
About SUPPRELIN LA
SUPPRELIN(R) LA was approved by the U.S. Food and Drug Administration(FDA) on May 3, 2007 and is a once-yearly implant which utilizes the Company'spatented HYDRON(R) Polymer Technology. The implant is inserted subcutaneouslyin the inner aspect of the upper arm and is specifically designed to provide acontinuous release over 12 months of approximately 65 mcg/day of thegonadotropin releasing hormone agonist (GnRHa) histrelin to reduce sexhormones and delay early puberty. SUPPRELIN LA is contraindicated in patientswith hypersensitivity to GnRH or GnRH analogs.
About Central Precocious Puberty
Central precocious puberty (CPP) is the premature development of secondarysex characteristics that normall
