Arbor announced that the Food and Drug Administration (FDA) has approved Triptodur (triptorelin) for the treatment of pediatric patients aged ≥2 years with central precocious puberty (CPP). This marks the first gonadotropin-releasing hormone (GnRH) agonist approved for dosing once every 6 months for CPP.

GnRH-dependent CPP refers to pubertal development occurring before age 8 in girls and before age 9 in boys. Triptodur was evaluated in a Phase 3 study that showed a return to pre-pubertal luteinizing hormone (LH) levels in 93% of study patients with 98% of patients maintaining pre-pubertal LH suppression at 12 months. In the study, the most frequent adverse events were injection site reactions and menstrual bleeding.  

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Triptodur will be available as a 22.5mg strength powder cake for reconstitution for intramuscular (IM) injection with diluent and supplies. It is anticipated to launch in the 4th quarter of 2017. 

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