Arbor and Debiopharm announced the launch of TriptodurTM (triptorelin extended-release suspension) injection for the treatment of central precocious puberty (CPP) in patients aged ≥2 years following its approval in June 2017.1
Triptodur, a gonadotropin-releasing hormone (GnRH) agonist, is given as an intramuscular (IM) injection every 6 months. Treatment with Triptodur returns the child’s luteinizing hormone (LH) levels to a normal pre-pubertal level, stopping the signs of puberty until an age appropriate time. In a phase 3 study (Efficacy, Safety, and Pharmacokinetics [PK] of Triptorelin 6-month Formulation in Patients with Central Precocious Puberty; ClinicalTrials.gov identifier NCT01467882),2 Triptodur restored pre-pubertal LH levels in 93% of patients after 6 months, and in 98% of patients after 12 months.
Common adverse reactions with Triptodur include injection site reactions, menstrual bleeding, hot flush, headache, cough, and infections.
Triptodur is available as a single-use kit containing 22.5 mg strength powder cake for reconstitution with co-packaged 2 mL diluent.
“We are pleased to be providing this important new treatment option for children diagnosed with CPP,” said Ed Schutter, president and CEO of Arbor. “We believe that many providers, patients and parents will appreciate the convenience Triptodur offers through a once-every 6-month dosing schedule.”
- Arbor Pharmaceuticals, LLC and Debiopharm International SA announce commercial availability of TriptodourTM, triptorelin 6-month formulation, for treatment of central precocious puberty [news release]. Atlanta, GA: Arbor Pharmaceuticals, LLC. http://arborpharma.com/10032017.php. Published October 3, 2017. Accessed October 18, 2017.
- Klein K, Yang J, Aisenberg J, et al. Efficacy and safety of triptorelin 6-month formulation in patients with central precocious puberty. J Endocrinol Metab. 2016;29(11):1241-1248. doi:10.1515/jpem-2015-0376
This article originally appeared on MPR