相关临床试验
7
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2009
已完成
6
85.7%
终止
1
14.3%
暂无批准数据
- The Emirates Drug Establishment has issued favorable pricing certificates for PHEXX, marking a preliminary administrative step toward regulatory approval in the UAE. - PHEXX is positioned to become the first and only hormone-free contraceptive vaginal gel approved in the UAE, with a planned 2026 launch. - Pharma 1 holds exclusive commercialization rights for PHEXX across six Gulf Cooperation Council states with potential expansion to 15 additional MENA countries. - The hormone-free contraceptive works by maintaining vaginal pH that is naturally inhospitable to sperm and certain pathogens without disrupting the normal microbiome.
- Evofem Biosciences announced that a new U.S. patent covering SOLOSEC (secnidazole) for trichomoniasis treatment has been listed in the FDA Orange Book, extending market exclusivity until December 2041. - The company now holds eleven Orange Book-listed patents for SOLOSEC, the first and only single-dose oral treatment FDA-approved for both bacterial vaginosis and trichomoniasis in the United States. - An ongoing NIH-funded Phase 4 clinical trial is evaluating SOLOSEC's effectiveness versus metronidazole, with investigators hypothesizing 1.75 times lower repeat infection rates with the single-dose regimen. - Trichomoniasis affects an estimated 6.9 million Americans annually and represents the most common non-viral sexually transmitted infection worldwide, highlighting the clinical significance of improved treatment options.
- Pharma 1 Drug Store has submitted PHEXXI for marketing approval to the UAE Ministry of Health and Prevention, marking a key milestone in Evofem's international expansion strategy. - The FDA-approved hormone-free contraceptive gel represents the first locally-acting contraceptive that maintains vaginal pH to prevent sperm viability without systemic hormonal effects. - Commercial launch is targeted for Q1 2026 in the UAE, with Pharma 1 holding exclusive rights across multiple Middle Eastern markets including Kuwait, Saudi Arabia, and Qatar. - Market research indicates growing demand for hormone-free, on-demand contraception in the UAE and surrounding region, positioning PHEXXI to address unmet needs in women's reproductive health.
- A pilot study of 15 women demonstrated that once-weekly oral secnidazole granules reduced bacterial vaginosis recurrence to 20% over 28 weeks, compared to CDC-recommended treatments with 35-70% recurrence rates. - The simplified treatment protocol addresses patient compliance barriers associated with current complex regimens that require daily dosing for multiple days or intravaginal applications. - Secnidazole's superior oral absorption and longer elimination half-life compared to metronidazole may contribute to its effectiveness in suppressive therapy for recurrent bacterial vaginosis. - The findings support potential expansion of secnidazole use beyond acute bacterial vaginosis treatment to long-term management of recurrent cases.
- Windtree Therapeutics has entered into a License and Supply Agreement with Evofem Biosciences to become the sourcing partner for PHEXXI, a hormone-free contraceptive vaginal gel that generated over $19 million in annual revenue in 2024. - The partnership aims to significantly reduce manufacturing costs for PHEXXI, potentially enabling Evofem to expand into new price-sensitive global markets where non-hormonal contraceptives are in high demand. - This agreement represents the first step in Windtree's recently announced corporate strategy to transform into a revenue-generating biotechnology company while continuing development of its therapeutic pipeline.
