Searle's endometriosis drug nafarelin acetate (Synarel) nasal solution has an FDA-approved labeling change that adds new information concerning the drug's clinical pharmacology.
The labeling now states that a single controlled trial showed that a 400-mcg/day dose of intranasal nafarelin acetate was comparable to intramuscular leuprolide depot 3.75 mg monthly for the treatment of symptoms associated with endometriosis (including dysmenorrhea, dyspareunia, and pelvic pain).
Also added to the labeling is a new section under "Adverse Reactions." The new text states that bone mass as measured by dual X-ray bone densitometry decreased 3.2% after 6 months of treatment with Synarel. A reexamination of mean total vertebral mass 6 months after completion of treatment found bone mass was 1.4% below pretreatment level.
Copyright Springhouse Corporation Apr 1999
Provided by ProQuest Information and Learning Company. All rights Reserved
Contact
Home
A
Growth hormone