Retired UIC Pharmacy Professor’s Drug Approved by FDA

When retired UIC College of Pharmacy professor Donald Waller, along with his best friend, Lourens Zaneveld, began working on their next-generation contraceptive for women, they sought to fill a simple, but widespread, need in the market.

"What we tried to do was develop an on-demand contraceptive for women that could be used when needed that wasn't a steroid or implant and could provide additional protection against Sexually Transmitted Disease. We wanted something inexpensive, easily made and available to everybody," Waller recalls. "That was what was really important to us.

"That's what we achieved."

As of this past May, Waller and Zaneveld's discovery, called Phexxi, became the world's first and only non-hormonal prescription gel approved by the U.S. Food and Drug Administration for the prevention of pregnancy and a potential to prevent sexually transmitted disease.

Waller, who teaches at UIC as a Professor of Pharmacology and Toxicology in the department of Pharmaceutical Sciences, began developing the idea behind the gel with Zaneveld, of Rush University Medical Center, 15 years ago.

"At the time, we thought the concept was naive, but worthwhile," Waller recalls. "If you look at the mechanism that sperm uses to penetrate the egg, it's a similar process that pathogenic organisms use to gain access to tissues and infectivity.

"We thought we had something."

Waller recalls that, also at that time, Zaneveld had been doing some work with acrosin inhibitors. Acrosin is an enzyme that plays a key role in the sperm's penetration of the egg. When the researchers decided to look into whether or not those same substances were effective on pathogens, their suspicions were confirmed.

"It started us on this path toward something that could inhibit sperm, but prevent STDs as well," Waller comments.

What they ended up with accomplished this in an even simpler way.

The pH level of the vagina, Waller explains, is already naturally hostile to sperm as well as most pathogens. When introduced to the vagina, semen alters its pH, neutralizing acidity and lowering defenses against pregnancy and infection.

Waller and Zaneveld decided to see if they could take advantage of this natural barrier that was already in place.

"If we have the capacity to maintain the pH of the vaginal vault so that it would not allow sperm to be active, we also deactivate viruses and pathogens."

Waller and Zaneveld's concept, which is co-patented by UIC and Rush, was licensed to Evofem Bioscences, Inc., in 2003. Evofem developed the gel for commercial use through clinical trials and FDA approvals.

While Phexxi is not yet FDA-approved for STD prevention, Waller expects that time will bear out its potential. And, even though he admits the concept is "very low-tech," Waller believes this gives the contraceptive an edge.

In terms of long-term efficacy, its mechanism, which focuses on a basic process--maintaining pH level--lessens the likelihood for mutations to occur and drug resistance to occur over time, explains Waller.

In terms of availability, Phexxi's simple formulation holds another advantage, which fulfills one of the initial goals Waller and Zaneveld set out to achieve at the beginning of their endeavor.

"High-tech may be good for the U.S. or Western Europe, but not for the developing world, which needs something inexpensive and easily produced," says Waller, who became involved with contraceptive research early on in his career through a grant from the World Health Organization. "If you look at the components, there's nothing there that's unusual. They're all easily obtained products." Those products include lactic acid, citric acid and potassium bitartrate. An additional product is currently being developed using a similar philosophy, but with a more robust activity against sexually transmitted diseases.

As a result, Waller and Zaneveld have essentially created a tool by which women around the world will be provided the ability to take control of both their reproductive rights as well as sexual health.

"In many places in the world, women in relationships can have very little decision-making power," Waller comments. A product used for preventing STDs might not be well-received by a male partner.

"A lot of subtle things go into developing these products. As scientists, we must also consider the behavioral and sociological aspects that will impact the success or failure of this type of a product which spans both contraception and prevention of sexually transmitted diseases."

"My hope is that women feel empowered with a new option to protect themselves."

According to Evofem, Phexxi is expected to hit the market in September, alongside a telehealth support service to educate and support access for women.