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.
- 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.
- 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