SAN DIEGO, Oct. 1, 2025 — Evofem Biosciences announced that its Middle East partner has submitted an application to the UAE Ministry of Health and Prevention (MOHAP) for marketing approval of SOLOSEC® (secnidazole), an FDA-approved, single-dose oral therapy for bacterial vaginosis (BV) and trichomoniasis. This marks the company’s first ex-U.S. regulatory filing, with a potential UAE launch in the first half of 2026.
Science Significance
SOLOSEC is a 5-nitroimidazole antibiotic that treats BV and trichomoniasis in a single oral dose, simplifying therapy and improving adherence compared with multi-day regimens. Both infections are highly prevalent, with studies showing BV affects up to 41% of women in the MENA region, while trichomoniasis impacts about 4.7% of women. The therapy’s one-dose complete treatment course is designed to reduce recurrence and improve compliance.
Regulatory Significance
This submission represents a critical regulatory milestone for SOLOSEC, expanding its footprint beyond the U.S. The review by MOHAP will determine its availability in the UAE, where high prevalence rates of both BV and trichomoniasis highlight the urgency for accessible treatment. The filing also strengthens the drug’s global regulatory strategy, potentially paving the way for expansion across the Gulf Cooperation Council (GCC).
Business Significance
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Approval and launch in the UAE would mark SOLOSEC’s entry into the Middle East pharmaceutical market, expanding Evofem’s revenue streams and strengthening its global presence in women’s health and anti-infective therapies. Through its regional partner, distribution and commercialization will be managed locally, enabling rapid market access.
Patients’ Significance
For patients, especially women, SOLOSEC offers convenient, effective, and rapid relief from infections that often carry stigma, recurrence, and severe health risks if untreated. For men and women with trichomoniasis, the treatment provides a fast and reliable option that may improve compliance and limit disease transmission, significantly impacting public health outcomes.
Policy Significance
The UAE filing reflects the importance of regional regulatory collaboration in addressing unmet health needs. Policies that support women’s health innovations and access to single-dose anti-infectives could play a critical role in reducing the burden of sexually transmitted infections (STIs) across the Middle East and beyond.
The regulatory submission of SOLOSEC in the UAE underscores a pivotal step for women’s health and STI management. With strong scientific rationale, regulatory momentum, and patient-centered benefits, this milestone could expand access to a much-needed therapy and strengthen global strategies against reproductive and sexual health infections.
Source: Evofem Biosciences, Inc. press release
