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Evofem's SOLOSEC Submitted for Marketing Approval in United Arab Emirates
Prnewswire· 2025-10-01 12:47
Core Viewpoint - Evofem Biosciences, Inc. has announced that its licensee Pharma 1 has filed for regulatory approval in the UAE to commercialize SOLOSEC, an FDA-approved treatment for bacterial vaginosis and trichomoniasis, targeting a launch in the first half of 2026 [1][2]. Company Overview - Evofem Biosciences focuses on innovative products for women's sexual and reproductive health, generating revenue from two FDA-approved products, SOLOSEC and PHEXXI [9][10]. - Pharma 1, an Emirati healthcare company, holds exclusive commercialization rights for SOLOSEC and PHEXXI in the MENA region, including the UAE, Kuwait, Saudi Arabia, and Qatar [2][13]. Product Details - SOLOSEC is a single-dose oral treatment for bacterial vaginosis and trichomoniasis, providing a complete course of therapy in just one dose [4][11]. - The prevalence of bacterial vaginosis in the MENA region ranges from 25% to 41%, with an estimated 1.0 million to 1.7 million women affected in the UAE alone [4][5]. Market Opportunity - The Gulf Cooperation Council (GCC) region has millions affected by bacterial vaginosis and trichomoniasis, indicating a significant market opportunity for SOLOSEC [2][6]. - The WHO estimated 156.3 million new cases of trichomoniasis globally in 2020, highlighting the ongoing need for effective treatments [5][8]. Strategic Goals - Pharma 1 aims to develop a commercial strategy for SOLOSEC and expects strong reception in the medical community and among patients seeking convenient treatment options [2][3]. - Evofem views this filing as a critical step towards expanding its revenue streams beyond the U.S. market [2][3].