New contraceptive gel – from bench to US FDA approval

Research into the development of a new vaginal gel, initiated by UniSA Pharmaceutical Scientist, Professor Sanjay Garg, has now been approved by the US FDA as the first and only non-hormonal contraceptive.

Begun as a post-doctoral research project, the gel has undergone several iterations, culminating in the patents and soon-to-be released contraceptive, made of compounds that restore and maintain the protective vaginal environment.

Professor Garg says the project began with a clear aim to empower women with a gel that would be binding, longer lasting, and protect against conception and sexually transmitted diseases including AIDS.

First patents on the research were filed in 2000 but Professor Garg says continued research and testing, and trials completed in 2018, have led to development of the gel which will be brought to market in the United States by Evofem Biosciences, as Phexxi, a nonhormonal, on-demand, vaginal pH regulator contraceptive.

“The beauty of this gel is the lack of active ingredients or drugs, it works to maintain and restore healthy vaginal pH, which is inhospitable for the survival of sperm,” Prog Garg says.

Unlike many vaginal gels, the new product has been designed to stay put, minimising leakage and maximising its effectiveness for longer. It is also made without some of the harsh additives of other gels which included detergents and often caused irritation or conditions such as vaginitis.

“It is extremely rewarding to see this product get to market, the journey of Phexxi from the bench to FDA approval on May 22, 2020 has confirmed the long incubation period for development of new drugs,” Prof Garg says.

“We hope to achieve the second-generation product that we are currently working on to reach the users much faster.

“My original research aim was to develop a microbiocide that would be a safeguard against STDs and AIDS – something that could be a game changer for high risk populations and that was easy for women to use.”

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