FDA approves first non-hormonal prescription contraceptive gel

26 May 2020 --- The US Food and Drug Administration (FDA) has approved a mix of lactic acid, citric acid and potassium bitartrate as the first non-hormonal prescription gel for the prevention of pregnancy. Evoferm Biosciences’ Phexxi is touted as being a new class of female-controlled birth control for use in-the-moment and works by maintaining the vaginal pH within the normal range of 3.5 to 4.5 – an acidic environment that is inhospitable to sperm. Phexxi is set to launch in early September in tandem with a telemedicine support system, tapping into the major trend of remote health services.

“There have been a limited number of advances in birth control over the last two decades; Phexxi represents an important step forward in women’s health,” says Michael Thomas, Chair of the Department of Obstetrics and Gynecology at the University of Cincinnati College of Medicine. “Many of my patients have cycled through numerous contraceptive options and still haven’t found the right fit for their sexual and reproductive needs. Phexxi offers women freedom from hormones and control over how they choose to prevent pregnancy. I look forward to offering this new on-demand option to my patients.”

Phexxi is set to be launched together with Phexxi Concierge Experience, a comprehensive patient and healthcare provider telemedicine support system. These services are designed to provide physicians with on-demand educational support, as well as speeding and simplifying women’s access to Phexxi. Through the Concierge Experience, women will be able to secure a prescription, determine their insurance coverage or out-of-pocket costs, receive counseling support and refill reminders, and fill their prescription through their local neighborhood pharmacy or an online pharmacy, which can then deliver Phexxi directly to their homes.

Remote ways to interact with consumers have been increasingly prolific across the health sector, even before COVID-19 created a sense of urgency. Earlier this month, Pharmavite launched a personalized vitamin subscription service that allows consumers to curate a 30-day supply of grab-and-go vitamin packets that are delivered to their homes. Meanwhile, the CEO of Persona Nutrition, which provides consumers with personalized vitamin and mineral packs, previously told NutritionInsight how more and more people are turning to telehealth appointments.

At the start of this year, Abbott highlighted that the rise of healthcare access via remote monitoring is a major shift to expect. Notably, Kroger Health has now launched a free telenutrition service to help US consumers shop for, prepare and enjoy healthy, fresh and non-perishable foods during the COVID-19 outbreak.

Empowerment from innovation
Evoferm Biosciences states that Phexxi is the first vaginal pH regulator with this unique mechanism of action. The company is now working to have Phexxi covered under the Affordable Care Act (ACA). The ACA mandates that private health plans provide coverage with no out-of-pocket costs for one treatment per class in each of the classes identified by the FDA for women in its Birth Control Guide. The company will also provide a financial assistance program to enable access for eligible women.

“The FDA approval of Phexxi means women now have access to a non-hormonal contraceptive option that they control, on their terms, to be used only when they need it. Empowerment results from innovation and we are proud and excited to deliver new innovation to women in a category ready for change,” explains Saundra Pelletier, Evofem Biosciences’ CEO.

Contraception is just one avenue of women’s health needs, which shift in nature throughout life stages. This space is seeing a wealth of activity, with Chr. Hansen Holding recently acquiring Austrian B2B company HSO Health Care to bolster its position in the probiotics for women’s health. Earlier this month, Gnosis by Lesaffre highlighted a new review detailing the potential mechanisms of Quatreflora Biotic for vaginal infections caused by fungi and bacteria.

By Katherine Durrell