Arbor Pharmaceuticals, LLC and Debiopharm International SA announce commercial availability of Triptodur, triptorelin 6-month formulation, for treatment of central precocious puberty (CPP).
Arbor Pharmaceuticals, LLC, a U.S. based specialty pharmaceutical company, and Debiopharm International SA, part of Debiopharm Group, a Swiss-based global biopharmaceutical company, announced that Triptodur (triptorelin) is now commercially available in the U.S. for the treatment of pediatric patients 2 years and older diagnosed with central precocious puberty (CPP)—a rare condition that affects one in every 5,000 to 10,000 children.1
“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 six-month dosing schedule.”
CPP is a condition that occurs when a child shows signs of puberty earlier than normal: before age 8 in girls and age 9 in boys.2,3 Without appropriate treatment, children with CPP will be shorter in height than their peers due to premature fusion of growth plates.4 CPP has also been associated with low self-esteem and higher anxiety, irritability or withdrawal.5-7,12
“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 may be returned to a normal level, slowing the clinical signs of puberty until an age appropriate time.”
Triptodur (triptorelin) is the first gonadotropin-releasing hormone (GnRH) agonist administered through intramuscular injection (IM) to offer once-every six-month dosing.8 This treatment helps to return hormone levels in children to a normal prepubertal level, pausing the clinical signs of puberty until an age appropriate time. GnRH agonists are the primary treatment for CPP and can help preserve time in childhood.9
“We are very pleased to offer this well tolerated and efficacious triptorelin formulation to children suffering from central precocious puberty, for which no other 6-month GnRH agonist formulation is approved”, said Eija Lundstrom, Medical Director, Debiopharm International SA.8
Triptodur (triptorelin) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of children with CPP. In a phase III clinical trial, Triptodur (triptorelin) demonstrated a return to pre-pubertal luteinizing hormone (LH) levels in 93 percent of patients after 6 months of treatment, and in 98 percent of patients after 12 months.10
The most common adverse reactions in clinical studies were injection site reactions, menstrual (vaginal) bleeding, hot flush, headache, cough, and infections (bronchitis, gastroenteritis, influenza, nasopharyngitis, otitis externa, pharyngitis, sinusitis, and upper respiratory tract infection).
Triptorelin extended release formulations were developed by Debiopharm and are manufactured in Switzerland by Debiopharm Research & Manufacturing SA. Arbor acquired exclusive U.S. commercial rights to Triptorelin 6-month for CPP in November 2015 and it was approved by the U.S. FDA in June 2017.
About Central Precocious Puberty (CPP)
GnRH-dependent CPP is defined by pubertal development occurring before the age of 8 years in girls and 9 years in boys.1-2 It is characterized by early pubertal changes such as breast development and start of menses in girls and increased testicular and penile growth in boys, appearance of pubic hair, as well as acceleration of growth velocity and bone maturation and tall stature during childhood, which often results in reduced adult height due to premature fusion of the growth plates.11
Reliable epidemiological data on CPP worldwide is not available. The condition is a rare disease occurring in about 1 out of every 5,000 to 10,000 children.3 Central precocious puberty is more common in girls than in boys, with a female: male ratio estimated to be between 3:1 and 23:1.10
1 Partsch CJ, Sippell WG. Treatment of central precocious puberty. Best Pract Res Clin Endocrinol Metab.2002;16:165-189.
2 Muir A. Precocious puberty. Pediatr Rev. 2006;27:373-381.
3 Carel JC, Léger J. Clinical practice. Precocious puberty. N Engl J Med. 2008;358(22):2366-2377.
4 Carel JC, Lahlou N, Roger M & Chaussain JL. Precocious puberty and statural growth. Human Reproduction Update. 2004;10:135–147.
5 Precocious puberty. Mayo Clinic Web site. http://www.mayoclinic.org/diseases-conditions/precocious-puberty/symptoms-causes/dxc-20266003. Accessed June 21, 2017.
6 Mendle, J., et al. Detrimental Psychological Outcomes Associated with Early Pubertal Timing in Adolescent Girls. Dev Rev. 2007; 27(2): 151-171.
7 Johansson T & Ritzen EM. Very long-term follow-up of girls with early and late menarche. Endocrine Development. 2005;8:126-136.
8 Triptodur [package insert]. Atlanta, GA: Arbor Pharmaceuticals, LLC. http://arborpharma.com/docs/TriptodurFullProductInformation.pdf
9 Faqua JS. Treatment and outcomes of precocious puberty: an update. J Clin Endocrinol Metab. 2013;98(6):2198-207.
10 Klein K, 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.
11 Antoniazzi F, Zamboni G. Central precocious puberty: current treatment options. Paediatr Drugs. 2004;6:211-231.
12 Early Puberty. Lurie Children’s Web site. https://www.luriechildrens.org/en-us/care-services/conditions-treatments/early-puberty/Pages/index.aspx. Accessed June 21, 2017.
(Source: PR Newswire)