NEW ORLEANS, LA – The U.S. Food and Drug Administration (FDA) has approved Phexxi™ (lactic acid, citric acid, and potassium bitartrate), marking a major advancement in women’s reproductive health as the first and only non-hormonal, on-demand prescription contraceptive gel. Developed by Evofem Biosciences, Phexxi empowers women with a hormone-free method of birth control that is used only when needed. Rachel Hastings, Managing Partner at DelRicht Research, emphasized the significance of this breakthrough for women’s reproductive autonomy and praised Dr. Patrick Dennis for his pivotal role in the trial.

Dr. Patrick Dennis, Principal Investigator at Touro Medical Center in New Orleans, LA, contributed to the pivotal trials supporting this approval in collaboration with DelRicht Research. Dr. Dennis has conducted multiple clinical studies across therapeutic areas since 2016, with a strong emphasis on women’s health and advancing patient-centered solutions.

Rachel Hastings on a New Class of Female-Controlled Birth Control

Phexxi is a vaginal pH regulator that works by maintaining the body’s natural acidic environment, which is inhospitable to sperm. Unlike daily hormonal pills or long-acting devices, Phexxi offers on-demand use without hormones, giving women greater flexibility and control over their reproductive choices. It is available in a convenient, pre-filled applicator and is designed to be used before intercourse, only when needed.

In clinical studies, Phexxi demonstrated reliable contraceptive efficacy and was generally well-tolerated. Most reported side effects were mild and included vulvovaginal irritation and urinary tract discomfort. Importantly, Phexxi does not affect long-term fertility and is not associated with the systemic effects or hormonal fluctuations of traditional contraceptive options.

“This approval is a landmark moment for women who have long been seeking birth control options that align with their personal and medical needs,” said Rachel Hastings, Managing Partner at DelRicht Research. “Dr. Dennis and the Touro site played a critical role in bringing this innovative solution to life, and we’re proud to support the future of female-controlled contraception.”

“This approval is a landmark moment for women who have long been seeking birth control options that align with their personal and medical needs. Dr. Dennis and the Touro site played a critical role in bringing this innovative solution to life, and we’re proud to support the future of female-controlled contraception.”

— Rachel Hastings, Managing Partner at DelRicht Research

Local Research Elevating National Impact

The approval of Phexxi represents not only a win for women’s health but also a testament to the importance of local research partnerships. Dr. Dennis’s contributions helped ensure that the study included a diverse and representative patient population, vital for bringing equitable, real-world treatments to market.

“For many women, hormonal birth control is not a preferred option, or even an option at all,” said Dr. Patrick Dennis, Principal Investigator. “Phexxi is a meaningful step forward because it gives women autonomy to make choices that work for them, on their terms.”

“For many women, hormonal birth control is not a preferred option, or even an option at all. Phexxi is a meaningful step forward because it gives women autonomy to make choices that work for them, on their terms.”

— Dr. Patrick Dennis, Principal Investigator at DelRicht Research

Evofem also launched the Phexxi Concierge Experience, a telehealth platform designed to streamline access to prescriptions, counseling, and pharmacy delivery. The company is actively working to expand insurance coverage and financial assistance to ensure broad patient access.

Empowerment Through Innovation

With its non-hormonal, woman-controlled, and as-needed approach, Phexxi redefines what modern contraception can look like. The approval signals a long-awaited innovation in reproductive care and reflects the combined efforts of visionary biotech companies, forward-thinking investigators, and engaged research networks like DelRicht.

DelRicht Research and principal investigator Dr. Dennis are proud to have supported the development of Phexxi, a product that stands to empower millions of women with more control over how and when they manage pregnancy prevention.

Read the full press release on Biospace.