Debiopharm Announces Phase III Positive Results for Triptorelin 6-month Formulation
News May 22, 2015
Debiopharm International SA (Debiopharm) has 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.
“The reduced injection frequency has the potential advantage of improving compliance to treatment and increasing comfort for children with CPP, for which no other 6-month GnRH agonist formulation is currently approved.” says Dr Eija Lundstrom, Medical Director at Debiopharm. “We remain committed to developing treatments that improve the quality of life of patients.”