Two new strengths in a three-month formulation expand Lupron Depot-PED dosing options for children with CPP
Food and Drug Administration (FDA) has approved two new strengths for three-month administration of Lupron Depot-PED (leuprolide acetate for depot suspension) for the treatment of children with central precocious puberty (CPP).
The approval of two new three-month depot strengths of Lupron Depot-PED is important because it adds additional treatment options for children with CPP and may reduce the number of injections per year from 12 to four," said Eugene Sun, M.
Patients with central precocious puberty who have been prescribed Lupron Depot-PED receive an injection that is administered in the physician office.
In patients who had not been previously treated for CPP, the onset of hormone suppression was consistent with other currently available Lupron Depot-PED formulations.
Treatment with Lupron Depot-PED will help allow these children to return to being children again.
Lupron Depot-PED, an analog of naturally occurring GnRH, stimulates the pituitary gland continually rather than in bursts.
In two clinical trials, Lupron Depot-PED was found to be safe and effective in treating these children.
While children are in treatment, they receive a monthly injection of Lupron Depot-PED and undergo regular blood tests to ensure that puberty is being suppressed.