FDA: Triptorelin Slows Central Precocious Puberty

The US Food and Drug Administration (FDA) has approved triporelin (Triptodur™, Arbor Pharmaceuticals) in pediatric patients with central precocious puberty, according to an Arbor Pharmaceuticals press release.¹

The approval follows a phase 3 clinical trial² (Efficacy, Safety, and Pharmacokinetics [PK] of Triptorelin 6-month Formulation in Patients with Central Precocious Puberty; ClinicalTrials.gov identifier NCT01467882) examining prepubertal luteinizing hormone levels at the conclusion of triporelin therapy.

 

The gonadotropin-releasing hormone (GnRH) agonist is administered through intramuscular injection; it offers once every 6-month dosing and achieved results in 93% of patients. Results were maintained at 12 months in 98% of patients between the ages of 2 and 9. 

“Early puberty in a child can pose significant physical and emotional challenges throughout their life,” said Karen Klein, MD, a pediatric endocrinologist at University of California, San Diego and Rady Children’s Hospital in California. “With treatment, hormone levels in children with [central precocious pubertys] are returned to a normal level, slowing the clinical signs of puberty until an age appropriate time.” 

The most common adverse side effects of triporelin are injection site reactions and menstrual bleeding.

References

1. Arbor Pharmaceuticals, LLC Announces FDA Approval for Triptodur™ [press release]. Atlanta, GA: Arbor Pharmaceuticals.  http://arborpharma.com/06292017.php. Published June 30, 2017. Accessed July 7, 2017.
2. Klein K, Yang J, Aisenberg J, et al. Efficacy and safety of triptorelin 6-month formulation in patients with central precocious puberty. J Pediatr Endocrinol Metab. 2016;29(11):1241-1248. doi:10.1515/jpem-2015-0376