FDA Approves Triptodur for Central Precocious Puberty
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.
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.
For more information call (866) 516-4950 or visit Triptodur.com.