PharmaShots Interview: Dr. Bassem Maximos Shares Insights from New Research on Evofem’s Non-Hormonal Contraceptive Gel, P-III (AMPOWER) Study

Shots:

Bassem spoke about the new data presented in a poster presentation at the ACOG annual meeting
The data was based on the P-III (AMPOWER) study, which evaluates Evofem’s nonhormonal contraceptive gel to prevent pregnancy
The interview gives an understanding of how Evofem is developing innovative products to improve women's health

Smriti: Please highlight the study design of the P-III (AMPOWER) clinical trial evaluating Phexxi.

Bassem Maximos:

AMPOWER was a phase 3, single-arm, multicenter (112 sites) study that evaluated the contraceptive efficacy/safety of the vaginal pH modulator, Phexxi® (lactic acid, citric acid, and potassium bitartrate) vaginal gel over 7 cycles of use in sexually active women aged 18-35 years. AMPOWER provided the data submitted to and reviewed by the FDA for the approval of Phexxi to prevent pregnancy. Phexxi is the only FDA-approved, non-hormonal, on-demand form of contraception that is controlled by a woman prior to vaginal intercourse. The objective of this post hoc analysis from the AMPOWER trial was to characterize women who experienced urinary tract infections (UTIs) while using Phexxi in the trial.
As the AMPOWER trial was a regional study, Evofem effectively utilized the opportunity to collect and analyze post hoc data, including the post hoc characterization of women who experienced urinary tract infections in the Phase 3 AMPOWER trial. This data concludes that the percentage of women who experienced an on-study UTI (5.8%) in AMPOWER was lower than the prevalence of UTIs in the general population of the US (11.0%).

Smriti: Explain the details (MOA, ROA, formulations, etc.) of Phexxi.

Bassem Maximos: Phexxi is a vaginal pH modulator. An expected pH in a healthy vagina ranges from 3.5-4.5. When semen enters the vagina, the pH increases to between 6.5-7.2, allowing sperm to move up the reproductive canal. When Phexxi is inserted into the vagina, it allows the vagina to maintain a normal pH in the range of 3.5-4.5, which lowers sperm mobility. When sperm cannot move up the reproductive canal, it reduces the chance of sperm reaching an egg and causing conception. Phexxi’s innovation is based in the lactic acid, citric acid, and potassium bitartrate vaginal gel inside an applicator. A woman uses the applicator, similar to that of a tampon, and inserts the applicator into the vagina, pushing the vaginal gel into the vagina and allowing the pH of the vagina to remain at 3.5-4.5 and thus, inhospitable to sperm.

Smriti: How is Phexxi different and more beneficial from conventional contraceptives?

Bassem Maximos: Phexxi is the only FDA-approved, non-hormonal, on-demand form of contraception that a woman controls before vaginal intercourse. There is no need for a daily pill, no need to take hormones that have a systemic, body-wide impact on women, and no need to have a device inserted for the long term into a woman’s body to prevent pregnancy. Phexxi provides women a new, on-demand form of contraception that men have always had through condoms.

Smriti: What are the key findings of the P-III (AMPOWER) clinical trial that Evofem presented at ACOG 2022?

Bassem Maximos:

Evofem submitted a post hoc analysis to ACOG analyzing data from the AMPOWER P-III trial regarding the characterization of women who experienced urinary tract infections in the Phase 3 AMPOWER trial. ACOG accepted the study for an electronic poster presentation. Dr. Bassem Maximos, a board-certified and practicing obstetrician and gynecologist in the Houston, Texas area presented the data for 30 minutes during ACOG 2022.
The key findings from the study showed the following:
- Compared to the overall AMPOWER safety population, women who experienced on-study UTIs had similar baseline characteristics and slightly lower product use.
- The percentage of women who experienced an on-study UTI (5.8%) in AMPOWER was lower than the prevalence of UTIs in the general population of the U.S. (11.0%)

Smriti: Tell us more about the product theatre that Evofem hosted at ACOG 2022 and what additional information was offered to the healthcare providers?

Bassem Maximos: Evofem hosted a product theatre on the first day of ACOG aimed at educating ACOG attendees about Phexxi. More than 60 attendees listened as Dr. Jennifer Broad, a board-certified obstetrician practicing in Newport Beach, California described Phexxi and how it prevents pregnancy. Dr. Broad took the audience, made up mostly of fellow OB/GYNs through a presentation that explained everything from Phexxi’s mechanism of action to its efficacy rate. Dr. Broad used the time to help her fellow practitioners understand the benefits offered by Phexxi through FDA-approved, non-hormonal, on-demand, woman-controlled contraception.

Smriti: Does Evofem plan to extend its pipeline with other products for improving women's health (both sexual & reproductive)?

Bassem Maximos:

Along with the UTI data presented at ACOG 2022, the peer-reviewed Journal of Sexual Medicine recently published sexual satisfaction data associated with the use of Phexxi. The analysis titled, “The Sexual satisfaction results with the vaginal pH modulator from the phase 3 AMPOWER study”, showed that 88.7% of women using Phexxi maintained or improved their sexual satisfaction. Both the UTI and sexual satisfaction data add to the growth of understanding of Phexxi and how it can help women maintain and improve their sexual and reproductive health.
Later this year, Evofem will readout topline data from the largest trial ever to investigate prophylactic for women for the prevention of chlamydia and gonorrhea. In the registrational EVOGUARD P-III trial, clinical trial investigators are studying women using Phexxi to determine the incidence of chlamydia and gonorrhea in the study population. If successful, EVOGUARD will produce the first-ever and only data showing efficacy in preventing chlamydia and gonorrhea, two of the most common infections in the United States, in women.
The EVOGUARD trial has the potential to expand the Phexxi label to include the prevention of chlamydia and gonorrhea, along with the already approved indication of prevention of pregnancy.

Source: Canva

About the Author:

Dr. Bassem Maximos, MD, MPH, FACOG is a board-certified Obstetrics & Gynecology Specialist in private practice in League City, TX. Dr. Maximos has extensive experience in obstetric care and gynecologic conditions and served as a private investigator in many clinical trials. He is a volunteer assistant professor at the University of Houston school of medicine. Dr. Maximos earned his bachelor’s in arts and sciences from La Sierra University in California, and earned his Medical Doctor's degree and a master’s in public health from St George’s University in Grenada, W.I.