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Two Year Study Confirms SUPPRELIN(R) LA Implant Maintains Profound Suppression of Hormones in Children With Premature Onset Puberty
Date:5/5/2008

rt for patients and families using or considering using SUPPRELIN LA for the treatment of central precocious puberty."

About the Study

The study was a multi-center, prospective extension study following an initial 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, a pediatric surgeon removed the first implant and inserted a second during the same procedure. Clinic visits occurred every six months, while GnRHa stimulation tests were performed at one and 12 months following placement of the second implant and bone ages were obtained annually. Primary outcome was peak luteinizing hormone (LH), which helps regulate the menstrual cycle and egg production in females, after GnRHa stimulation test.

Peak LH declined from 0.92 +/- 0.58 mIU/mL at 12 months to 0.51 +/- 0.33 mIU/mL at 24 months (p< 0.0001) in the naive group and from 0.74 +/- 0.50 mIU/mL at 12 months to 0.45 +/- 0.35 mIU/mL at 24 months (p = 0.0005) in previously 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 to 88.00 +/- 19.63 at 24 months (p=0.0389). Continued prospective follow up studies are needed to investigate long term effects of the SUPPRELIN LA subcutaneous 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's patented HYDRON(R) Polymer Technology. The implant is inserted subcutaneously in the inner aspect of the upper arm and is specifically designed to provide a continuous release over 12 months of approximately 65 mcg/day of the gonadotropin releasing hormone agonist (GnRHa) histrelin to reduce sex hormones and delay early puberty. SUPPRELIN LA is cont
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SOURCE Indevus Pharmaceuticals, Inc.
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