On October 25, 2010, the nonprofit microbicide research organization CONRAD announced that the U.S. Food and Drug Administration (FDA) would consider the Vaginal and Oral Interventions to Control the Epidemic (VOICE) trial as a confirmatory trial to the CAPRISA 004 results (see TAGline vol 17, no. 3). Further, the FDA has agreed to accept fasttrack designation for the 1% tenofovir gel microbicide, meaning that the clinical trial sponsor may submit completed sections of the new drug application for review by the FDA rather than waiting until the entire application is complete. This can speed the way for approval if the VOICE trial results confirm those obtained in CAPRISA 004. The FDA did identify some specific additional information that will be required, including safety data in adolescents, in-vivo drug interaction studies with commonly used vaginal products, and data on postmenopausal women. In addition to VOICE, follow-up trials in South Africa will proceed, but the fate of a larger multicountry study planned by the UK’s Microbicide Development Programme (named MDP302) remains uncertain; after the CONRAD announcement, the MDP issued a statement welcoming the FDA’s decision but also explaining why they feel MDP302 is still justified.
To see the CONRAD announcement go to http://www.conrad.org/news.html
To see the MDP response go to: http://www.mdp.mrc.ac.uk