For Immediate Release
October 25, 2010
FDA and CONRAD Chart U.S. Regulatory Path for 1% Tenofovir Gel for
Collaborative meeting held with key stakeholders
Arlington, VA – – The U.S. Food and Drug Administration (FDA) held an end-of-Phase II
meeting to determine the next steps required for U.S. licensure of 1% tenofovir gel, a
microbicide product recently found to be effective at reducing the rate of HIV and herpes infection
in women when used before and after sex.
The meeting, held on October 20, 2010, was requested by CONRAD, a division of the Eastern
Virginia Medical School in Norfolk, VA. CONRAD was one of the partners in the Phase II
study, “CAPRISA 004,” which evaluated 1% tenofovir gel in prevention of male-to-female HIV
transmission in 889 women in South Africa. USAID provided funding for the trial, conducted
by the Centre for Programme Research for AIDS in South Africa and U.S. based FHI, which was
the first study to show that a vaginal gel can reduce the risk of HIV and herpes infection in
women. CONRAD manufactured and provided the tenofovir gel for the study.
Tenofovir gel was found to be 39% effective in reducing a woman’s risk of becoming infected
with HIV during sex and 51% effective in preventing genital herpes infections in the women
participating in the trial. Results of the CAPRISA 004 clinical trial were reported in July 2010
and represent the first “proof of concept” for a vaginal microbicide.
A number of key stakeholders contributed to the collaborative meeting with the FDA, including
representatives from the U.S. National Institutes of Health, the U.S. Agency for International
Development, Gilead Sciences, Microbicides Trial Network (MTN), South African clinical
investigators, the International Partnership for Microbicides (IPM) and FHI.
During the meeting, the FDA stated their preference for two well-controlled studies to verify the
safety and efficacy of 1% tenofovir gel prior to submission of a New Drug Application (NDA).
The FDA furthermore stated that the NIH-sponsored Phase IIB study, MTN-003, known as
VOICE (Vaginal and Oral Interventions to Control the Epidemic), represents a second adequate
and well-controlled study that would, if successful, serve as the second pivotal trial together with
CAPRISA 004 to support the submission of an NDA for 1% tenofovir gel.
In addition, the FDA has granted Fast Track approval designation for 1% tenofovir gel, which
facilitates the development and expedites the review of drugs that are intended for treating
serious diseases and fill an unmet medical need. With Fast Track designation, an NDA can be
submitted as a “rolling review”, which allows a clinical trial sponsor to submit completed
sections of its NDA for review by the FDA, rather than waiting until every section of the
application is completed before the entire application can be reviewed.
The agency agreed that the current preclinical program for 1% tenofovir gel is sufficient to
support a future NDA. However, they stated that additional safety data on adolescents would be
needed and that information on in vivo drug interaction studies with commonly used vaginal
products should be obtained. Also, the FDA will ultimately need data on post menopausal
women. It was also agreed that a future meeting with the FDA would be held to address any
outstanding discussions associated with product quality, including chemistry, manufacturing and
controls (CMC). Since much of the clinical work on 1% tenofovir gel has been and will be
conducted in South Africa, FDA officials indicated that they can work through the FDA’s
“Office of International Programs” with the goal of coordinating the data and review processes
with the South African Medicines Control Council.
CONRAD and its partners appreciate the contributions and detailed recommendations put forth
by the FDA, which have helped clarify the next steps required for testing and licensure of 1%
In 2006, CONRAD and IPM obtained a co-exclusive, royalty-free license from Gilead Sciences
to develop 1% tenofovir gel as a topical microbicide for use by women in developing countries
to prevent HIV.
For more information, please contact Annette Larkin, +1 703 772 6427 or