Evofem Biosciences' Contraceptive Gel PHEXXI Seeks Marketing Approval in UAE.

Evofem Biosciences announced that Pharma 1 has submitted an application to the UAE Ministry of Health and Prevention for marketing approval of PHEXXI, a hormone-free contraceptive gel approved by the FDA. Pharma 1 plans to launch PHEXXI in the UAE in Q1 2026 and has exclusive commercialization rights for the Middle East region. Evofem CEO Saundra Pelletier expressed enthusiasm for expanding revenue streams with PHEXXI sales to Pharma 1.

SAN DIEGO, June 19, 2025 — Women's health innovator Evofem Biosciences, Inc. (OTCPK: EVFM) announced today that Pharma 1 Drug Store LLC has submitted an application to the United Arab Emirates (UAE) Ministry of Health and Prevention (MOHAP) seeking approval to commercialize PHEXXI®, a hormone-free contraceptive gel approved by the U.S. Food and Drug Administration (FDA). Pharma 1 plans to launch PHEXXI in the UAE in Q1 2026, with exclusive commercialization rights for the Middle East region [1].

The submission to MOHAP marks an important milestone for Evofem, as it seeks to expand and diversify its revenue streams with PHEXXI sales to Pharma 1. Evofem CEO Saundra Pelletier expressed enthusiasm for this development, stating, "We look forward to expanding and diversifying our revenue stream with PHEXXI sales to Pharma 1 for the UAE beginning in July 2025 to support the product launch in the UAE and provide Emirati women with access to hormone-free, non-systemic birth control that they control and use on-demand, only when needed" [1].

Pharma 1 Drug Store, an Emirati company dedicated to providing practical healthcare solutions, will handle all aspects of distribution, sales, marketing, and pharmacovigilance for PHEXXI in the UAE and other countries in the Middle East [1]. The company's success reflects its substantial expertise and scientific approach, which aligns with Evofem's mission to address unmet needs in women's sexual and reproductive health.

PHEXXI, the first and only locally-acting contraceptive gel approved by the FDA, is applied zero-to-60 minutes before intercourse using a pre-filled applicator. It works by maintaining the normal vaginal microbiome with a pH that is naturally inhospitable to sperm as well as certain viral and bacterial pathogens [1].

Evofem's commercial team relaunched SOLOSEC®, an oral antibiotic for bacterial vaginosis and trichomoniasis, in November 2024 and promotes the product alongside PHEXXI to OB/GYNs in the U.S. 2024 marked Evofem's fourth consecutive year of net sales growth [1].

References:
[1] https://www.morningstar.com/news/pr-newswire/20250623la15420/evofems-phexxi-submitted-for-marketing-approval-in-united-arab-emirates-by-pharma-1-drug-store