Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Triptodur Approved for Central Precocious Puberty

Arbor Pharmaceuticals news release; 2017 Jun 30

The FDA has approved Triptodur (triptorelin), available from Arbor Pharmaceuticals, for the treatment of pediatric patients with central precocious puberty (CPP).

Indications: Triptodur, a gonadotropin-releasing hormone (GnRH) agonist, is indicated in children 2 years of age and older who have central precocious puberty, which can occur before age 8 in girls and age 9 in boys. It has been proven effective in bringing luteinizing hormone levels to pre-pubertal levels in 93% of patients in a phase III clinical trial.

Dosage and administration: The drug is given as an intramuscular (IM) injection of 22.5 mg once every 6 months.

Adverse reactions: The most common adverse effects include injection site reactions, menstrual (vaginal) bleeding, hot flush, headache, cough, and infections, including bronchitis, gastroenteritis, influenza, nasopharyngitis, otitis externa, pharyngitis, sinusitis, and upper respiratory tract infection.

Citation:

Arbor Pharmaceuticals, LLC and Debiopharm International SA announce U.S. FDA approval for Triptodur, triptorelin 6-month formulation, in the treatment of central precocious puberty (CPP). http://www.prnewswire.com/news-releases/arbor-pharmaceuticals-llc-and-de.... Accessed July 11, 2017.

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