Daré Bioscience Announces Publication in Obstetrics & Gynecology of Phase 2b Study Efficacy Results of Topical Sildenafil Cream, 3.6% for the Treatment of Female Sexual Arousal Disorder
Daré Bioscience (NASDAQ: DARE) published the efficacy results of their Phase 2b study on topical Sildenafil Cream, 3.6% for treating Female Sexual Arousal Disorder (FSAD) in the journal Obstetrics & Gynecology. This double-blind, placebo-controlled study showed significant improvements in sexual arousal sensation, reduced sexual distress, and increased desire and orgasm, particularly in a subset of women with FSAD, with or without decreased desire. Currently, no FDA-approved therapies exist for FSAD. Daré had a positive end-of-Phase 2 meeting with the FDA and awaits feedback on proposed endpoints for Phase 3 trials, which is expected this quarter.
- Phase 2b study showed significant improvements in sexual arousal sensation, desire, and orgasm.
- Topical Sildenafil Cream reduced sexual distress among women with FSAD.
- No FDA-approved therapies currently exist for FSAD, highlighting the product's potential market impact.
- Positive end-of-Phase 2 meeting with the FDA supporting advancement to Phase 3 trials.
- Publication in a reputable journal validates the importance of the findings.
- The Phase 2b study results are still pending FDA review for comments and approval on endpoints for Phase 3 trials.
Insights
The publication of the Phase 2b study results in a peer-reviewed journal like Obstetrics & Gynecology is a significant milestone for Daré Bioscience. The study's demonstration of improved outcomes in women with FSAD, particularly those with and without decreased desire, suggests that Sildenafil Cream could address a critical unmet medical need.
Currently, there are no FDA-approved therapies for FSAD, which affects approximately
It is important for investors to note that the FDA is actively reviewing the Phase 2b data and is expected to provide comments on the proposed endpoints for Phase 3 trials. This interaction with the FDA indicates potential regulatory support, which is a positive signal for the advancement of the product. However, investors should be aware that the transition from Phase 2 to Phase 3 is a critical juncture where many drug candidates face significant challenges.
Overall, the publication strengthens the scientific validity of the product, potentially increasing its marketability and investor interest.
From a financial perspective, this development is promising for Daré Bioscience. The publication in a reputable medical journal and the positive end-of-Phase 2 meeting with the FDA are indicators of potential future approval and commercialization. The absence of FDA-approved therapies for FSAD positions Sildenafil Cream to potentially capture a substantial market share if approved.
Investors should consider the current market dynamics. FSAD affects a significant portion of the female population, making this a potentially lucrative market. Additionally, the FDA's active engagement suggests that the regulatory pathway may be smooth, albeit not guaranteed.
The company's stock (NASDAQ: DARE) could see increased investor interest and possibly a higher valuation as the product advances through the clinical trial phases. However, it's important to remain cautious, as the upcoming Phase 3 trials will require significant investment and hold inherent risks.
In summary, the financial outlook is positive but tempered by the usual risks associated with clinical development.
Phase 2b study demonstrated topical Sildenafil Cream,
There are currently no FDA-approved therapies for FSAD
SAN DIEGO, June 24, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, today announced the publication in Obstetrics & Gynecology, the official publication of the American College of Obstetricians and Gynecologists (ACOG), of the Phase 2b study efficacy results of topical Sildenafil Cream
The Phase 2b clinical study was designed as an exploratory, multi-center, double-blind, placebo-controlled study to evaluate the preliminary efficacy and safety of Sildenafil Cream,
“Arousal disorder represents a significant unmet need, impacting approximately
“We are so pleased that this manuscript has been accepted in the official publication of the American College of Obstetricians and Gynecologists,” added Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “It truly underscores the importance of these groundbreaking data and can hopefully continue to advance the field with the insights these data provide into this patient population as well as the patient reported outcome measures that are most meaningful to them in measuring their improvement.”
Daré Bioscience previously announced a positive end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) supporting advancement of Sildenafil Cream for the treatment of FSAD and has continued to interact with the FDA as the FDA reviews, specifically, the data generated on the proposed endpoints to take forward into Phase 3 development. The FDA has indicated that it aims to complete its review of the Phase 2b study data and provide comments this quarter on the proposed primary and secondary patient reported outcome endpoints for the planned Phase 3 pivotal trials of Sildenafil Cream to support potential product registration and labeling.
The in-press accepted manuscript, entitled “Preliminary Efficacy of Topical Sildenafil Cream for the Treatment of Female Sexual Arousal Disorder: A Randomized Controlled Trial” is available online at https://journals.lww.com/greenjournal/fulltext/9900/preliminary_efficacy_of_topical_sildenafil_cream.1101.aspx.
About FSAD and Sildenafil Cream,
FSAD, as described in the DSM-IV, is a condition characterized as primarily by a persistent or recurrent inability to attain or maintain sufficient genital arousal (an adequate lubrication-swelling response) during sexual activity, frequently resulting in distress or interpersonal difficulty, and, of the various types of female sexual dysfunction disorders, FSAD is clinically analogous to erectile dysfunction (ED) in men. As with ED in men, FSAD is associated with insufficient blood flow to the genitalia.
Sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra® for the treatment of ED in men. Sildenafil Cream is an investigational, proprietary cream formulation of sildenafil designed for topical administration to the vulvar-vaginal tissue on demand to increase genital blood flow and provide improvements in the female genital arousal response, while avoiding systemic side effects observed with oral formulations of sildenafil.
Market research suggests that
About Daré Bioscience
Daré Bioscience is a biopharmaceutical company committed to advancing innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, vaginal health, reproductive health, menopause, sexual health and fertility.
The first FDA-approved product to emerge from Daré’s portfolio of women’s health product candidates is XACIATO™ (clindamycin phosphate) vaginal gel
Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma 2022. In 2023, Daré's CEO was honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions to innovation and advocacy in the women’s health space. Daré Bioscience placed #1 in the Small Company category of the San Diego Business Journal’s 2023 Best Places to Work Awards.
Daré may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company and may also use social media to communicate important information about the company, its finances, product and product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré’s website.
Forward-Looking Statements
Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “objective,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to Sildenafil Cream’s potential as a safe and effective therapy for FSAD, Daré’s plans for continued clinical development of Sildenafil Cream, the timing of FDA comments on Sildenafil Cream Phase 3 clinical study design, the potential for Sildenafil Cream to be the first FDA-approved treatment of FSAD, and the potential market opportunity for Sildenafil Cream. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: Daré’s ability to raise additional capital when and as needed to advance its product candidates, execute its business strategy and continue as a going concern; the risk that data from the Phase 2b study may not be predictive of positive results of any future clinical study; the risk that the FDA, other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Daré’s interpretation of or conclusions regarding the study data; the risk that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate; Daré’s ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates; Daré’s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; the loss of, or inability to attract, key personnel; the effects of macroeconomic conditions, geopolitical events, public health emergencies, and major disruptions in government operations on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; the risk that developments by competitors make Daré’s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Daré’s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage or reimbursement from third-party payers; Daré’s ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré’s ability to satisfy the monetary obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its product and product candidates; Daré’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré’s product candidates which could expose its products to competition from other formulations using the same active ingredients; product liability claims; governmental investigations or actions relating to Daré’s product or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; cybersecurity incidents or similar events that compromise Daré’s technology systems or those of third parties on which it relies and/or significantly disrupt Daré’s business; and disputes or other developments concerning Daré’s intellectual property rights. Daré’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Contacts:
Media and Investors on behalf of Daré Bioscience, Inc:
Camilla White / Simona Kormanikova
Dentons Global Advisors
DareBioscience@dentonsglobaladvisors.com / 1.212.466.6450
Source: Daré Bioscience, Inc.
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¹ Laumann EO, Michael RT and Gagnon JH. A political history of the national sex survey of adults. Fam Plann Perspect 1994; 26: 34-38.
Witherow-Parkanyi M. Female sexual interest/arousal disorder: history of diagnostic considerations and their implications for clinical practice. Psychiatr Hung 2022; 37: 133-149.
Jayne C and Gago BA. Diagnosis and treatment of female sexual arousal disorder. Clin Obstet Gynecol 2009; 52: 675-681. DOI: 10.1097/GRF.0b013e3181bf4982.
FAQ
What were the results of the Phase 2b study on Daré Bioscience's Sildenafil Cream for FSAD?
When was the Phase 2b study on Daré Bioscience's Sildenafil Cream published?
What is the current status of Daré Bioscience's Sildenafil Cream with the FDA?
Are there any FDA-approved therapies for Female Sexual Arousal Disorder as of now?
What improvements were noted in the subset of women with FSAD in the Phase 2b study?
