Daré Bioscience Announces Phase 3 Plans For Sildenafil Cream, 3.6%, In The Treatment Of Female Sexual Arousal Disorder; Daré's Sildenafil Cream Has The Potential To Receive The First FDA Approval For FSAD
Daré Bioscience Announces Phase 3 Plans For Sildenafil Cream, 3.6%, In The Treatment Of Female Sexual Arousal Disorder; Daré's Sildenafil Cream Has The Potential To Receive The First FDA Approval For FSAD
FSAD is clinically analogous to erectile dysfunction in men.
To date, there are no FDA-approved pharmacological treatments for FSAD; Daré's Sildenafil Cream has the potential to receive the first FDA approval for FSAD.
FSAD在临床上类似于男性勃起功能障碍。
迄今为止,尚无FDA批准的FSAD药物治疗;Daré的西地那非乳膏有可能获得针对FSAD的首个FDA批准。
Market research estimates approximately 10 million women in the U.S. are distressed from experiencing symptoms associated with FSAD and are actively seeking solutions to improve their condition.
市场研究估计,美国约有1000万女性因经历与FSAD相关的症状而感到困扰,并积极寻求改善其控件的解决方案。
SAN DIEGO, Dec. 16, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in innovation for the health and wellbeing of women, and its collaborator Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced plans for a Phase 3 study of Sildenafil Cream, 3.6%, an investigational topical cream formulation of sildenafil being developed as an on-demand treatment for female sexual arousal disorder (FSAD), reflecting U.S. Food and Drug Administration (FDA) feedback for safety and efficacy evaluations to support the indication of treatment of FSAD in premenopausal women.
圣迭戈,2024年12月16日(全球新闻通讯)——Daré Bioscience, Inc.(纳斯达克:DARE),作为女性健康和福祉创新的领导者,以及其合作者Strategic Science & Technologies, LLC(SST),一家位于麻萨诸塞州剑桥的新型局部药物递送公司,今天宣布计划进行一项关于3.6%西地那非乳膏的第三阶段研究,这是一种正在开发中的西地那非局部乳膏制剂,作为女性性唤起障碍(FSAD)的按需治疗,反映了美国食品药品监督管理局(FDA)对安全性和有效性评估的反馈,以支持在绝经前女性中治疗FSAD的适应症。