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FDA Orange Book Lists New U.S. Patent for SOLOSEC, Evofem Biosciences' "One and Done" Oral Treatment for Bacterial Vaginosis and Trichomoniasis
Prnewswire· 2025-08-19 13:39
Core Points - Evofem Biosciences has secured a new U.S. patent for SOLOSEC, extending its market exclusivity until December 2041, which enhances the company's intellectual property portfolio and benefits stakeholders [2][4] - SOLOSEC is the first and only FDA-approved single-dose oral treatment for bacterial vaginosis (BV) and trichomoniasis, addressing a significant unmet need in women's sexual health [2][9] - The company is conducting a Phase 4 clinical trial to compare the effectiveness and cost-effectiveness of SOLOSEC against metronidazole, with expectations of lower reinfection rates in the SOLOSEC group [4] Company Overview - Evofem Biosciences focuses on innovative products for women's sexual and reproductive health, generating revenue from two FDA-approved products [5] - The company is in the process of a merger with Aditxt, Inc., which will result in Evofem becoming a wholly owned subsidiary of Aditxt [6] Industry Context - Trichomoniasis is the most common non-viral sexually transmitted infection globally, with approximately 6.9 million new infections occurring annually in the U.S., highlighting the need for effective treatment options [3][8]