FDA grant to help increase generic drugs delivered intravaginally or by IUD

Of the 21 drugs designed for delivery directly to the female genital tract, only four have a cost-effective, generic equivalent…

The FDA has awarded researchers at the University at Buffalo (UB) an $880,000 grant to help accelerate the development of generic equivalents of contraceptives and other drugs delivered vaginally or to the uterus.

There are currently 21 drugs delivered intravaginally or by intrauterine devices (IUD) – which includes contraceptives, antibiotics and antifungals. However, only four have a generic equivalent, leaving few cost-effective treatment alternatives for women.

The lack of generic drugs is partially tied to the complexity of intravaginal and intrauterine delivery, according to lead researcher Robert Bies, PharmD, PhD, associate professor in the UB School of Pharmacy and Pharmaceutical Sciences. The challenges of measuring drug release and absorption rates in vaginal and uterine tissues make it difficult for scientists to determine if a generic drug is bioequivalent, or has the same effect, as its brand name counterpart.

The UB investigators will develop a model of the female reproductive tract that will become a platform to test drugs delivered this way – a route more complex than administering medication through the mouth, vein, muscle or skin.

“This work represents an exciting opportunity to apply mathematical modeling and simulation techniques (pharmacometrics) in conjunction with experimental approaches to facilitate the understanding of drug delivery in the vaginal and uterine spaces,” says Bies.

“Given the dynamic and complex nature of the female reproductive tract, simulation models such as that being developed are critical to enhance efficiency of the development of safe and effective female drug products,” says Lisa Rohan, PhD, professor at the Magee-Womens Research Institute and the University of Pittsburgh. “This can potentially make new products available to women in a more rapid timeframe.”

The investigators will expand on a recently developed model that successfully predicted drug concentrations of a microbicide delivered vaginally. The model will be extended to simulate the physiology of the uterus, cervix and rectum, and will estimate drug permeation rates, release rates and absorption rates of levonorgestrel – a hormonal medication commonly used in birth control – in the various tissue areas, as well as across the body when delivered by an IUD.

Once the model can accurately predict levels of levonorgestrel concentration, the platform will be expanded to include other drugs.