Female Sexual Dysfunction

BioSante Pharmaceuticals LibiGel® Safety Study to Continue Following Review by External Executive Committee

"Based on the trial data to date, we are confident that the LibiGel Cardiovascular and Breast Cancer Safety Study should continue to enroll new subjects and maintain treatment of those subjects already randomized to therapy. At this point, we feel that the conduct of the study has been excellent and that the adverse event rates are exceptionally low in the trial – both from a cardiovascular and general safety standpoint," said Dr. William B. White, Chairman of the Safety Study External Executive Committee and Professor and Attending Physician, in the Calhoun Cardiology Center, University of Connecticut Health Center, Farmington.

The Executive Committee evaluated study information from over 1,000 women enrolled totaling approximately 600 women-years of exposure in the Phase III LibiGel safety study. All serious adverse events including those in the cardiovascular categories as well as non-serious adverse events have been reviewed by the committee.

"Our objective continues to be to submit a new drug application (NDA) to the U.S. FDA by the end of 2010 or in early 2011," said Dr. Michael Snabes, BioSante's vice president of clinical development. "We are heartened by the reassuring safety data to date in the three LibiGel Phase III clinical studies including the very important cardiovascular and breast cancer safety study. LibiGel remains the only pharmaceutical product in the U.S. in active development for the treatment of hypoactive sexual desire disorder (HSDD) in menopausal women. We continue to believe that LibiGel can be the first product approved by the FDA for this common and unmet medical need also referred to as female sexual dysfunction (FSD)."

The Phase III Cardiovascular and Breast Cancer Safety Study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events and breast cancer study that will enroll between 2,400 and 3,100 women exposed to LibiGel or placebo for 12 months. An NDA can be filed and reviewed by FDA, possibly leading to approval of LibiGel, at that time. After NDA submission and potential approval of LibiGel, BioSante will continue to follow the women enrolled in the study for an additional four years.

The LibiGel safety study is tracking a list of cardiovascular events including cardiovascular death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two cardiovascular risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of cardiovascular events. The incidence of breast cancer also will be tracked over the course of the study.

In addition to the Phase III cardiovascular and breast cancer safety study, BioSante is conducting two LibiGel Phase III efficacy trials. The Phase III efficacy trials of LibiGel in the treatment of FSD are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA approved SPA (special protocol assessment agreement).

Keywords: , Health, Biotechnology, Cardiology, Clinical Trials, Oncology, Pharmaceutical, Other Health, Research, OtheAdverse Drug Effect, Adverse Drug Event, Adverse Drug Reaction, Biotechnology, Breast Cancer, Breast Carcinoma, Cardiology, Cardiovascular, Clinical Trial Research, Drug Development, FDA, Oncology, Pharmaceuticals, Therapy, Treatment, U.S. Food and Drug Administration, Women's Health, BioSante Pharmaceuticals Inc.

This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2009, Biotech Business Week via NewsRx.com.