Female Condom Redesign Gets FDA Panel Endorsement
Full article reprinted from "The Gray Sheet" - December 15, 2008
Find out how the Female Health Company's update of its Reality female condom, which uses a different material and manufacturing process to lower costs, should be approved by FDA contingent upon a single labeling change, the agency's Obstetrics and Gynecology Devices Panel recommended Dec. 11.
Full article reprinted from "The Gray Sheet" - December 15, 2008
The advisory panel conditioned its 14-0 approval recommendation on an addition to labeling to make clear that the next-generation device (FC2) was proven non-inferior to the original (FC1, also known as Reality), but was not clinically evaluated separately for its ability to prevent pregnancy and sexually transmitted disease.
The firm is seeking PMA approval for FC2 to help prevent HIV/AIDS and unintended pregnancy.
Acknowledging a need both domestically and globally for prophylactic options that are acceptable and accessible to women, the panel agreed at the Gaithersburg, Md., meeting that FC2's benefits clearly outweigh the risks.
"I am impressed by the potential benefits of the new female condom, [which] appears to be at least as acceptable and perhaps more acceptable than the first version of the product, [and could] potentially empower more women to [take control of their sexual and reproductive health]," said panel member Paula Hillard, M.D., Stanford University Medical Center, Calif.
The panel's review of FC2 relied primarily on pre-clinical in vitro data for assessment of its effectiveness in preventing sexually transmitted infection (STI) and pregnancy.
FC1 was approved in 1993 on the basis of preclinical study data, small feasibility studies and a six-month contraceptive study; both FC1 and FC2 have received CE mark approval in Europe (1"The Gray Sheet" May 17, 1993, p. 6).
Though the panel opted not seek a post-market effectiveness study, the advisory group suggested that FDA work with the National Institute of Child Health & Human Development (NICHD) to further study effectiveness of female condoms.
FDA had asked NICHD to conduct post-market STI prevention studies when FC1 was approved in 1993, but the protocol was inadequate, according to a sponsor representative.
FC2 differs from FC1 in that its outer ring is made of a nitrile material, making it softer, more flexible and thicker. FC2 also is faster and less expensive to make than FC1 because it does not require welding, which also means it does not contain a seam. Instead, FC2 is made with a dipping process similar to that typically used for male condoms.
To compare FC2 to FC1, the Female Health Company sponsored a prospective, randomized, double-blinded, multi-center cross-over study at South African University of Witwatersrand's Reproductive Health & HIV Research Unit (RHRU) from January through September 2004.
The RHRU study assessed as a primary endpoint the acute failure rates of FC2 vs. FC1, including breakage, slippage out of the vagina, invagination of the outer ring into the vagina, and misdirection of the penis next to the condom and into the vagina.
Prior to condom use, study participants, who came from urban and rural family planning and STI clinics or were students or commercial sex workers, were briefed on their responsibilities in the study and its procedures, given verbal instructions for inserting and removing female condoms and educated on the importance of proper use.
Study participants were given 10 FC1 and FC2 condoms, and randomized as to the sequence of which version to use within a 2-3 month period, recorded in a coital log.
Failure Rate Of 2% Seen In Clinical Study
Of the 276 women enrolled at the outset, 201 (72.8%) completed the two follow-up visits and a majority of them had used at least eight condoms prior to each follow-up. Failure rates for FC1 and FC2 were 2.46% and 2.07%, respectively, and FC2 was determined to be statistically non-inferior.
If FC2 is approved, labeling would include a statement similar to that for FC1 noting that latex condoms for men "are highly effective. If not using a male condom, use a female condom for protection every time you have sex" and "before you try it, read instructions."
- Ingrid Mezo
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