Debiopharm Announces Completion of Recruitment for Phase III Clinical Study in CPP
News Jan 20, 2014
Debiopharm Group™ has announced that it has completed the recruitment of patients for its Phase III clinical study in Central Precocious Puberty (CPP) with triptorelin 22.5 mg.
Debiopharm is investigating the efficacy and safety of the gonadotropin releasing hormone (GnRH) agonist analog triptorelin pamoate 6-month formulation in the treatment of children suffering from central (GnRH-dependent) precocious puberty (CPP).
CPP is defined by pubertal development occurring before the age of 8 years in girls and 9 years in boys, which is not secondary to exposure to sex steroids of adrenal or gonadal origin (peripheral precocious puberty). This 6-month formulation offers an excellent treatment option in a pediatric indication due to less frequent injections.
No GnRH agonist 6-month formulation is currently approved for treatment of precocious puberty. The study is an international, multicenter, non-controlled phase III study on the efficacy, pharmacokinetics and safety of two consecutive intramuscular injections of the triptorelin pamoate 22.5 mg 6-month formulation over 12 months.
The protocol has gone through the US Food and Drug Administration (FDA) Special Protocol Assessment procedure. The recruitment has been completed and the results are expected in Q4 2014.
“We are very happy to have completed the recruitment in this study,” said Eija Lundström, Medical Director responsible for this project at Debiopharm International. “We are looking forward to the results at the end of this year as we believe that the 6-month formulation will simplify the treatment of CPP and make it more tolerable for this young population of patients.”