Two strengths of leuprolide acetate for depot suspension
in a 3-month formulation have been approved by the FDA for treatment of central
precocious puberty.
Leuprolide acetate for depot suspension (Lupron
Depot-PED, Abbott) is currently available as a 7.5-mg, 11.25-mg or 15-mg
once-monthly injection for children diagnosed with central precocious puberty.
The FDA’s decision now allows the drug to be administered in an 11.25-mg
or 30-mg dose every 3 months.
The manufacturer’s submission for approval was
based on data from a 24-week, open-label study involving 84 patients with
central precocious puberty. Patients received two injections, administered 12
weeks apart, and were followed for nearly 6 months to evaluate hormone
suppression and safety. Results indicated that hormone suppression with both
strengths of the 3-month depot formulation was sustained throughout the
treatment period. In previously untreated patients, the onset of hormone
suppression was consistent with other currently available formulations of the
drug. The most commonly reported side effects were injection-site pain, weight
gain, headache, altered mood and injection-site swelling. Other adverse
reactions included acne; rash with or without fever, blisters or sores, and
facial swelling; and vaginitis, vaginal bleeding or vaginal discharge.
“The approval of two new 3-month depot strengths of
Lupron Depot-PED is important because it adds additional treatment options for
children with [central precocious puberty] and may reduce the number of
injections per year from 12 to four,” Eugene Sun, MD, vice
president of global pharmaceutical development at Abbott, said in a press
release.
The new formulation is expected to be available in late
August.