A first-of-its-kind solution for women’s arousal – the same active ingredient as in Viagra® for men – in a proprietary topical formulation demonstrated to work where women need it most
Targeted to be available by prescription in the fourth quarter of 2025
SAN DIEGO, July 21, 2025 (GLOBE NEWSWIRE) — Daré Bioscience, Inc. (NASDAQ: DARE), a biopharmaceutical company with a sole focus of closing the gap in women’s health between promising science and real solutions, today announced a live webinar on Wednesday, August 6, 2025, unveiling the DARE to PLAY™ difference – a groundbreaking solution for female sexual arousal with the first and only evidence-backed sildenafil cream formulation for women.
Titled “The DARE to PLAY™ Difference: The Sildenafil Cream That Raises the Bar,” the webinar hosted in collaboration with The National Association of Nurse Practitioners in Women’s Health (NPWH) spotlights a breakthrough innovation: a topical formulation of sildenafil – the same active ingredient in Viagra® for men – developed specifically for women and clinically shown to improve genital blood flow and sexual response. Unlike other untested compounded products, DARE to PLAY™ is backed by clinical evidence and formulated to deliver sildenafil precisely where it can have its effect, closing a long-standing gap between promising science and real solutions for women.
The webinar will feature three of the nation’s leading sexual health thought leaders including Dr. Irwin Goldstein, a pioneering clinician and researcher who has studied and published on the effects of sildenafil for more than two decades. Together, they will highlight how DARE to PLAY™ is rewriting the narrative on female sexual arousal, finally bringing women a trusted, credible, and evidence-based option.
Highlights include:
- Why genital blood flow is central to arousal response in women – and how DARE to PLAY™ addresses this.
- Clinical evidence showing improvements in arousal, orgasm, and desire in women using the DARE to PLAY™ sildenafil cream.
- How DARE to PLAY™’s proprietary formulation is key to its clinical effect
- How Daré’s formulation expertise and clinical development experience bridge the gap between unmet need and real, evidence-based solutions.
Webinar participants will also have the opportunity to join the product alert list, ensuring they are among the first to know when DARE to PLAY™ sildenafil cream becomes available by prescription – expected in the fourth quarter of 2025.
The event is open to clinicians, investors, and women seeking a trusted, science-based approach to improving sexual response
Event Details:
Title: The DARE to PLAY™ Difference: The Sildenafil Cream That Raises the Bar
Speakers:
- Rose Hartzell-Cushanick, AASECT Certified Sex Therapist
- Sue Goldstein, CCRC, CSE, IF, International Society for the Study of Women’s Sexual Health (ISSWSH) Past President
- Irwin Goldstein, MD, IF, Founding Editor of The Journal of Sexual Medicine and ISSWSH Past President
Date: Wednesday, August 6, 2025
Time: 12:00pm ET
Registration: https://cvent.me/1aO4bb
About Daré Bioscience
Daré Bioscience is a biopharmaceutical company driven by a mission to challenge the status quo, making women’s health a priority. Daré believes that innovation does not have to start from scratch. The company’s goal is to bring to market as soon as practicable innovative evidence-based solutions that address decades of unmet needs in women’s health and enhance outcomes and convenience, primarily in the areas of contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health and menopause. The potential products Daré identifies, in many cases, already have clinical proof of concept or existing safety data for the active ingredient that the company leverages. This provides optionality and flexibility, in many cases, in how Daré seeks to bring solutions to market in ways designed to optimize access for women in a fiscally responsible manner.
The first FDA-approved product to emerge from Daré’s portfolio of women’s health product candidates is XACIATO™ (clindamycin phosphate) vaginal gel 2%, a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Visit www.xaciato.com for information about XACIATO. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil citrate, the active ingredient in an oral erectile dysfunction drug for men, to treat female sexual arousal disorder (FSAD); and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more about Daré’s full portfolio of women’s health product candidates and mission to deliver differentiated therapies for women, please visit www.darebioscience.com.
Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma and Daré’s CEO has been 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 may announce material information about its finances, products 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, products 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,” “on track,” 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 Daré’s go-to-market strategies; Daré’s plans and timing for making its proprietary formulation of sildenafil citrate available by prescription in the U.S. as a compounded drug via Section 503B of Federal Food, Drug, and Cosmetic Act (FDCA); the ability of DARE to PLAY™ sildenafil cream to provide a solution for women experiencing difficulties with sexual arousal, orgasm, and desire; the market opportunity for the product and its ability to gain market acceptance; and Daré’s development plans for the investigational products in its portfolio and their respective potential to complete clinical development and obtain regulatory approval. As used in this press release, “first-in-category” is a forward-looking statement relating to the potential of a product candidate to represent a new category of product if it were to receive marketing approval for the indication for which it is being developed because Daré believes it would address a need in women’s health that is not being met by existing U.S. Food and Drug Administration (FDA)-approved products. 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 execute its business strategy and continue as a going concern; the risk of delisting of Daré’s common stock from Nasdaq; Daré’s reliance on Section 503B-registered outsourcing facilities and other third parties to bring DARE to PLAY™ sildenafil cream and other solutions to market as compounded drugs or as consumer health products and facilitate access to such products and the risk that those third parties do not perform as expected; the risk that the FDA could stop permitting Section 503B-registered outsourcing facilities to compound sildenafil or other drug substances in the proprietary formulations Daré intends to bring or brings to market; the degree of market demand and acceptance for DARE to PLAY™ sildenafil cream and other products Daré brings to market; Daré’s reliance on third parties to manufacture and conduct clinical trials and preclinical studies of its product candidates and commercialize XACIATO™ (clindamycin phosphate) vaginal gel 2% and future products, if any; the risk that the current regulatory pathway known as the FDA’s 505(b)(2) pathway for drug product approval in the U.S. is not available for a product candidate as Daré anticipates; Daré’s ability to achieve the product development and other milestones required for it to receive payments under its subaward and grant agreements; the potential for termination of the subaward and grant agreements before Daré receives additional payments; the limits on Daré’s ability to sell stock under its equity line arrangement at times it may desire to raise additional capital; 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 and the inherent uncertainty of outcomes of clinical trials; 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 risks 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 and that interim data or results from a particular clinical study do not necessarily predict the final results for that 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 data from clinical studies of its product candidates; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates; the loss of, or inability to attract, key personnel; 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, pricing and reimbursement from third-party payors; 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 products or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; the effects of macroeconomic conditions, geopolitical events, and major changes and disruptions in U.S. government policies and operations on Daré’s ability to raise additional capital or 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; 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:
Daré Bioscience Investor Relations
innovations@darebioscience.com
Source: Daré Bioscience, Inc.
