Leuprolide acetate receives FDA new drug application

The FDA has approved a new drug application for leuprolide acetate for depot suspension, a 1-month formulation for the treatment of central precocious puberty. According to a company press release, this is the first in its class to include long-term data in its label for the treatment of this condition.

Now, the prescribing information for leuprolide acetate for depot suspension (Lupron Depot-PED, Abbott) contains 18 years of data, including pre-specified outcome results on puberty, height and reproductive function.

An open-label study of 55 patients, at a mean age of 7 years, was conducted to determine signs and symptoms of puberty, leuteinizing hormone, height and reproductive function. Clinical signs and symptoms of puberty were suppressed and normalized growth rates were achieved in most patients during treatment.

The post-treatment follow-up period included 40 children. Puberty resumed and 87.9% of patients achieved LH levels in the puberty range 6-months after treatment ceased. Thirty-three patients were observed until they achieved final or near final adult height, according to the press release. Patients experienced an average height gain more than predicted adult height before treatment. Eighty-percent of females surveyed after treatment reported normal menstrual cycles; seven of these reported pregnancies.

During the first 4 weeks of treatment, in some patients the signs and symptoms of central precocious puberty increased; these resolved over time, however. The most common side effects reported during treatment were sore throat, headache, flu syndrome and rash, injection site pain, moodiness and hot flushes.

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