Antares Pharma partner BioSante has announced that the LibiGel External Executive Committee Phase III clinical programme should continue based on positive results from the LibiGel Safety Study.
The decision of the committee was based on a review of the Phase III Cardiovascular and Breast Cancer Safety Study for LibiGel, which demonstrated a very low cardiovascular event rate in the LibiGel Phase III clinical studies.
The Executive Committee evaluated study information from over 1,000 women enrolled, totalling approximately 600 women-years of exposure in the LibiGel safety study.
Antares president and CEO Paul Wotton said that a transdermal gel offers an ideal means to deliver drugs such as testosterone in a controlled and reproducible way with a convenient-to-use dosage form.
“We are very pleased to see further and encouraging progress made with LibiGel, which uses the Antares Pharma ATD system, a US Food and Drug Administration-approved technology,” Wotton said.
All serious adverse events including those in the cardiovascular categories as well as non-serious adverse events have been reviewed by the committee.