Method for treating children with central precocious puberty using extended release composition

摘要

An extended release formulation for use in a method for treating a pediatric patient with central precocious puberty (CPP) 2 years of age or older is provided. The extended release formulation comprises leuprolide or a pharmaceutically acceptable salt thereof, a biodegradable polymer and a biocompatible organic solvent. Biodegradable polymers include poly(lactide-co-glycolide) (PLG) copolymer segments, poly(lactic acid-co-glycolic acid) (PLGA) copolymer segments, poly(lactide) (PL) polymer segments, poly( lactic acid) (PLA) polymer segments or combinations thereof. The extended release formulation is administered as a subcutaneous injection of the flowable composition forming an in situ solid depot. Extended release formulations release leuprolide for about 6 months to effectively treat CPP in pediatric patients.