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SAN DIEGO - Daré Bioscience, Inc. (NASDAQ: DARE), in partnership with Strategic Science & Technologies, LLC, has announced the upcoming Phase 3 clinical trial of Sildenafil Cream, 3.6%, aimed at treating Female Sexual Arousal Disorder (FSAD). The study will be based on the U.S. Food and Drug Administration (FDA) feedback, focusing on safety and efficacy in premenopausal women.
FSAD, which affects an estimated 10 million women in the U.S., is characterized by a persistent inability to maintain sufficient genital arousal. Currently, no FDA-approved pharmacological treatments are available for this condition, which is comparable to erectile dysfunction in men. Wall Street analysts see significant potential, with price targets ranging from $12 to $39, suggesting substantial upside potential from the current trading price of $3.18. Sildenafil, the active ingredient in Viagra®, has been reformulated into a topical cream for direct application, potentially avoiding the systemic side effects associated with oral medications.
The Phase 3 study will follow the Phase 2b RESPOND study, with a 12-week double-blind treatment period comparing the Sildenafil Cream to a placebo. The trial will use co-primary efficacy endpoints to assess arousal sensations and associated distress, with secondary endpoints evaluating improvements in orgasm, desire, and interpersonal difficulties.
Daré Bioscience is aiming to submit the protocol and statistical analysis plan for the Phase 3 study to the FDA in the first quarter of 2025, with the trial expected to commence in mid-2025. A second confirmatory Phase 3 study will be necessary to support the New Drug Application submission.
This development could mark a significant milestone in women's sexual health, as Sildenafil Cream has the potential to become the first FDA-approved treatment for FSAD, creating a new market category within the female sexual dysfunction space. The stock currently trades near its 52-week low of $3.05, compared to its high of $7.56. For deeper insights into Daré Bioscience's financial health and growth prospects, including 5 additional exclusive ProTips, check out the comprehensive research report available on InvestingPro.
Daré Bioscience is a biopharmaceutical company dedicated to advancing innovative products for women's health, with a portfolio that includes potential first-in-category candidates in various stages of clinical development. The company's commitment to women's health has been recognized with multiple awards and honors.
The information for this article is based on a press release statement from Daré Bioscience, Inc.
In other recent news, Daré Bioscience has reported significant advancements. The company has received $2.5 million for its contraceptive technology, DARE-LARC1, and displayed a strong revenue growth of 88% over the last twelve months, according to an analysis by InvestingPro. The company's third-quarter financial results revealed a comprehensive loss of $4.7 million, but also highlighted a decrease in R&D and administrative expenses. Despite the loss, Daré maintained a cash position of $11.2 million and secured over $20 million in non-dilutive funding, which will support the development of key products. In addition, Daré is strengthening its collaborations with Bayer (OTC:BAYRY) and has received significant funding from ARPA-H and the Gates Foundation. These recent developments further underline Daré Bioscience's commitment to advancing women's health therapies.
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