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FDA approves extended-release triptorelin for central precocious puberty

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The FDA has approved the gonadotropin-releasing hormone agonist triptorelin in a 6-month formulation for the treatment of central precocious puberty, Arbor Pharmaceuticals and Debiopharm International announced in a press release.

Triptorelin (Triptodur) is an extended-release injectable suspension approved to treat central precocious puberty in children aged 2 years and older. The approval marks the first new treatment formulation for U.S. children in 6 years and is the first GnRH agonist available for twice-yearly dosing in the U.S., according to the companies.

“We are excited to be bringing Triptodur, a new treatment option for children impacted by the disruptive effects of [central precocious puberty], to the U.S. market,” Ed Schutter, president and CEO of Arbor, said in the release. “Triptodur adds to our growing portfolio of approved medications that may help to improve the lives of our patients.”

In a phase 3 clinical trial, Triptodur demonstrated a return to prepubertal luteinizing hormone (LH) levels in 93% of patients, with prepubertal LH suppression maintained at 12 months by 98% of patients. The most common adverse reactions were injection-site reactions and menstrual bleeding.

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

Triptorelin was developed by Debiopharm and will be manufactured in Switzerland by Debiopharm Research and Manufacturing SA. Arbor acquired exclusive U.S. commercial rights to Triptorelin 6-month for central precocious puberty in November 2015. The drug should be available in the fourth quarter of 2017, according to the release.