Arbor Pharmaceuticals, LLC, a U.S.-based specialty pharmaceutical company, and Debiopharm International SA, part of Debiopharm Group, a Swiss-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Triptodur for the treatment of pediatric patients 2 years and older with central precocious puberty (CPP). CPP occurs when a child shows signs of puberty sooner than normal – before age 8 in girls and 9 nine in boys.
“We are excited to be bringing Triptodur, a new treatment option for children impacted by the disruptive effects of CPP, to the U.S. market,” said Ed Schutter, President and CEO of Arbor. “Triptodur adds to our growing portfolio of approved medications that may help to improve the lives of our patients.”
Triptodur, a gonadotropin-releasing hormone (GnRH) agonist administered through intramuscular injection (IM), is the first GnRH agonist to offer once-every six-month dosing approved for the treatment of CPP in the U.S. In a phase III clinical trial, Triptodur demonstrated a return to pre-pubertal luteinizing hormone (LH) levels in 93 percent of patients, with pre-pubertal LH suppression maintained at 12 months by 98 percent of patients. The most common adverse reactions are injection site reactions and menstrual (vaginal) 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,” said Karen Klein, M.D., Pediatric Endocrinologist, University of California San Diego and Rady Children’s Hospital. “With treatment, hormone levels in children with CPP are returned to a normal level, slowing the clinical signs of puberty until an age appropriate time.”
“We are extremely pleased to provide this pediatric population with the option of the triptorelin six-month formulation”, said Eija Lundstrom, Medical Director, Debiopharm International SA. “This will allow children to benefit from an effective and well tolerated treatment with only two injections per year.”
The approval brings new CPP treatment formulation to U.S. children for the first time in six years.
Triptorelin was developed by Debiopharm and will be manufactured in Switzerland by Debiopharm Research & Manufacturing SA. Arbor acquired exclusive U.S. commercial rights to Triptorelin 6-month for CPP in November 2015. Triptodur is expected to be available in the fourth quarter of 2017.
Filed Under: Drug Discovery