Evofem Biosciences, a leading innovator in women’s health, announced that its licensee in the Middle East and North Africa, the private Emirati healthcare company Pharma 1, has submitted an application to the United Arab Emirates (UAE) Ministry of Health and Prevention (MOHAP) seeking marketing authorization for SOLOSEC (secnidazole) 2 g oral granules.

This filing marks the first regulatory submission for SOLOSEC outside the United States and represents a significant milestone in Evofem’s international expansion strategy. SOLOSEC is an FDA-approved, single-dose oral antimicrobial indicated for the treatment of bacterial vaginosis (BV) in females 12 years and older, and trichomoniasis, a common sexually transmitted infection, in both males and females aged 12 and older.

"Bacterial vaginosis and trichomoniasis affect millions of people across the Gulf Cooperation Council (GCC) region," said Abdulwahab Atfah, CEO of Pharma 1 Drug Store. "SOLOSEC provides a convenient, single-dose oral treatment for both conditions. With the regulatory submission now complete, we are actively developing our commercial strategy and preparing for a targeted launch in the UAE during the first half of 2026. We anticipate strong demand from healthcare providers, women with BV, and individuals seeking effective and convenient treatment for trichomoniasis."

Evofem CEO Saundra Pelletier emphasized the importance of this international milestone, stating, "This submission is a major step toward the global commercialization of SOLOSEC and supports our goal of diversifying and expanding our revenue base. We look forward to Pharma 1’s initial order and the subsequent launch in the UAE following approval."

Pharma 1 holds exclusive commercialization rights for both SOLOSEC and PHEXXI (lactic acid, citric acid, and potassium bitartrate) across several MENA countries, including the UAE, Saudi Arabia, Kuwait, Qatar, and others. The company is responsible for securing regulatory approvals and managing all distribution, sales, marketing, and pharmacovigilance activities within the licensed territory.

SOLOSEC offers a complete, single-dose oral treatment that addresses the challenges of treatment adherence and undiagnosed infections associated with multi-day therapies.

Evofem and Pharma 1 remain committed to expanding access to innovative, convenient, and clinically proven treatments that address unmet needs in sexual and reproductive health.