Date: 2015-05-19
Type of information: Results
phase: 3
Announcement: results
Company: Debiopharm (Switzerland)
Product: sustained release triptorelin pamoate 22.5 mg 6-month-formulation
Action
mechanism: peptide. Triptorelin is a synthetic decapeptide agonist analogue that was first registered in France in 1986 and is currently marketed in more than 80 countries in various indications including advanced prostate cancer and CPP. Chronic administration of triptorelin causes down regulation of the pituitary GnRH receptors and suppresses gonadotropin (LH and FSH) secretion and finally the release of gonadal sex-hormones. Triptorelin shows a safety profile similar to other GnRH agonists. Except for injection site reactions or rare immunoallergic reactions, the side effects of triptorelin are mostly due to the initial increase in testosterone/oestrogen levels (e.g. vaginal bleeding in girls) followed by almost complete suppression of testosterone/oestrogen (e.g. hot flushes and headaches).
Disease: central precocious puberty (CPP)
Therapeutic area: Rare diseases - Endocrine diseases - Hormonal diseases
Country: USA, Chile, Mexico
Trial
details: The multicentre, open-label, non-randomised study will involve 44 children from the United States, Chile and Mexico. Its primary objective is to evaluate the efficacy and safety of triptorelin pamoate (embonate) 22.5 mg 6-month formulation in decreasing luteinizing hormone (LH) to prepubertal levels at Month 6 (Day 169) in children with CPP. (NCT01467882)
Latest
news: * On May 19, 2015, Debiopharm International announced the completion of an international, multicenter, non-comparative phase III study with triptorelin embonate (pamoate) 22.5 mg 6-month formulation in 44 patients (39 girls and 5 boys) with central precocious puberty (CPP). The mean age of the patients at the time of diagnosis was 7 years (range 1 to 9 years). The results of this 12-month study show that the triptorelin 6-month formulation is efficacious in suppressing the pituitary release of LH (luteinizing hormone) and FSH (follicle-stimulating hormone), and consequently the gonadal secretion of estradiol in girls and testosterone in boys to prepubertal levels, with favorable effects on progression of clinical signs of puberty and bone maturation. The percentage of children with prepubertal LH levels exceeded 93% at each time point on-treatment and reached 98% at month 12 when all but one patient were suppressed. The clinical signs of puberty (Tanner) were stable or reduced in the vast majority of patients (89%) between baseline and month 12. Administration of the triptorelin 6-month formulation was well tolerated and safe with no unexpected adverse events reported. * On August 27, 2012, Debiopharm Group, a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs and companion diagnostics, has announced that the first patient has been enrolled 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).
“We are excited to be part of this study, which is the first Debiopharm-sponsored clinical trial using triptorelin for the treatment of CPP,” said Rolland-Yves Mauvernay, President and founder of Debiopharm Group. “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. 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”.
