FDA Approves Precocious Puberty Treatment
The FDA has approved Triptodur, Triptorelin 6-month Formulation, for the treatment of pediatric patients 2 years and older with central precocious puberty (CPP).
The gonadotropin-releasing hormone (GnRH) agonist is administered via intramuscular injection and is the first GnRH agonist to offer once-every-6-months dosing approved for the treatment of CPP in the US.
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Precocious Puberty: An Infant With a Virilizing Ovarian Tumor
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The effectiveness of Triptodur was established in a phase III clinical trial in which 93% of participants given the drug experienced a return to pre-pubertal luteinizing hormone levels and pre-pubertal luteinizing hormone suppression maintained at 12 months in 98% of participants.
The most common adverse events experienced by patients taking Triptodur were injection site reactions and menstrual bleeding.
—Michael Potts
Reference:
Arbor Pharmaceuticals, LLC announces FDA approval for Triptodur [press release]. Atlanta, Georgia. June 30, 2017. http://arborpharma.com/06292017.php.