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news.Swiss-based biopharmaceutical company, Debiopharm has enrolled first patient in an open-label phase III study to investigate the efficacy, safety and pharmacokinetics of the sustained release triptorelin pamoate 22.5 mg 6-month-formulation in children with central precocious puberty (CPP), a rare disease.
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The study, which will enroll 44 children from the US, Chile and Mexico, aims to decrease luteinizing hormone (LH) to prepubertal levels at month 6 (Day 169) in children with CPP using triptorelin pamoate 22.5 mg.
Debiopharm president and founder Rolland-Yves Mauvernay said Debiopharm is excited to be part of the first Debiopharm-sponsored clinical trial using triptorelin for the treatment of CPP.
"Our aim is to show that a gonadotropin-releasing hormone (GnRH) agonist therapy prevents the social and psychological difficulties associated with premature sexual development, and has a positive impact on compromised adult height," Mauvernay added.
"The 6-month-formulation would entail an improved compliance in a paediatric indication for which no other 6-month GnRH agonist formulation is currently approved, whilst reducing the frequency of injections in children."
GnRH-dependent CPP is defined by pubertal development occurring before the age of 8 years in girls and 9 years in boys.