Daré Bioscience and Rosy Wellness Launch First Phase of Patient-Focused Campaign to Support DARE to PLAY™ Sildenafil Cream

Rhea-AI Summary

Daré Bioscience (NASDAQ: DARE) and Rosy Wellness have announced the launch of a consumer awareness campaign for DARE to PLAY™ Sildenafil Cream, a groundbreaking topical formulation for women's arousal targeted for prescription availability in Q4 2025.

The campaign leverages Rosy's platform of 250,000+ women and includes an Arousal Collection and educational "Quickie" videos featuring expert Dr. Sameena Rahman. The product contains sildenafil (Viagra's active ingredient) and is clinically proven to improve genital blood flow and sexual response. This collaboration marks the first phase of a broader initiative that will include healthcare provider awareness and customer support programs.

DARE to PLAY™ will be available as a compounded drug under Section 503B of the FDCA, representing a significant advancement in women's sexual health treatment backed by clinical evidence.

Positive

• First-of-its-kind clinically proven topical solution for women's arousal
• Large potential reach through Rosy Wellness' community of 250,000+ women
• Backed by clinical evidence unlike other compounded products
• Strategic partnership with established digital wellness platform

Negative

• Product launch still pending Q4 2025 availability
• Will require prescription access, limiting immediate accessibility
• Regulatory status as compounded drug under Section 503B rather than full FDA approval

Insights

Biopharmaceutical Analyst

Daré's sildenafil cream launch campaign signals potential commercialization milestone, targeting unmet women's health need with Rosy Wellness partnership.

Daré Bioscience's announcement about their DARE to PLAY™ Sildenafil Cream campaign represents a significant pre-commercialization milestone for this women's health-focused company. The collaboration with Rosy Wellness strategically leverages an established digital platform with 250,000 women users to build product awareness ahead of their targeted Q4 2025 prescription availability.

The product itself addresses a substantial market gap – it's a female-specific formulation of sildenafil (Viagra's active ingredient) developed as a topical cream to enhance genital blood flow and sexual response. Unlike compounded alternatives, Daré emphasizes this is backed by clinical evidence and precisely formulated for targeted delivery.

What's particularly notable is the commercialization pathway. Daré plans to make DARE to PLAY available as a compounded drug under Section 503B of the FDCA. This regulatory approach potentially offers a faster route to market compared to traditional FDA approval pathways, which could accelerate revenue generation while potentially establishing market presence.

The educational campaign's digital-first approach through mobile devices aligns with modern consumer behavior patterns. Creating specialized content like the "Arousal Collection" and "Quickie" videos featuring sexual medicine experts demonstrates a sophisticated marketing strategy aimed at both building awareness and establishing scientific credibility.

This announcement suggests Daré is executing on its commercialization strategy for a product that addresses a significant unmet need in women's sexual health. The market potential could be substantial if the company successfully leverages Rosy's platform to reach their target audience and convert awareness into prescriptions when the product launches.

A first-of-its-kind solution for women’s arousal 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

Collaboration leverages Rosy Wellness’ extensive reach and community of over 250,000 women; campaign designed to drive awareness and support women with arousal concerns

SAN DIEGO, July 29, 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, and Rosy Wellness, a pioneering digital platform focused on providing lifespan support for women, today announced the launch of the first phase of a consumer awareness campaign to support the upcoming introduction of DARE to PLAY Sildenafil Cream.

DARE to PLAY Sildenafil Cream is 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 campaign launches this week with the debut of new educational content designed to reach women where they are through their mobile devices with evidence based, engaging information about female sexual health. The campaign will include the release of an Arousal Collection and Quickie hosted on the Rosy platform that educate women about physical arousal and provide guidance on how DARE to PLAY may support women experiencing arousal concerns.

Quickies are short-form video content designed to combat misinformation on social media. Each video is reviewed for clinical accuracy before approval and showcases content created by leading healthcare professionals (HCPs). With a library of over 700 videos, Quickies delivers accessible, trustworthy education in an engaging format.

The Quickie featuring Dr. Sameena Rahman, a board-certified Ob/Gyn, sexual medicine expert, ACOG Fellow, and Fellow of the International Society for the Study of Women’s Sexual Health (ISSWSH), who currently serves as the Scientific Program Committee Chair on the ISSWSH Board of Directors, will help women understand the biology of arousal and what makes DARE to PLAY unique among current offerings.

Collections are masterclass-style courses composed of short, interactive modules that deliver engaging, expert-led content. Each module includes knowledge checks to help users reflect on changes in their understanding and intentions, along with curated resources to guide them toward meaningful next steps. The Arousal Collection, which is also authored by Dr. Rahman, offers a deeper, guided journey through the topic of physical arousal and how it fits into the broader cycle of sexual response, what influences it, and how DARE to PLAY fits into a personalized approach to managing arousal challenges. Both tools are designed to combat misinformation and make expert-led sexual health education more accessible.

“These new tools represent a major step forward in closing the information gap in women’s sexual health,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “We are proud to partner with Rosy to deliver evidence-based, user-friendly content that empowers women to take charge of their sexual wellness and understand how DARE to PLAY may help.”

“This partnership is exactly the kind of innovation Rosy was built to support: combining expert-led education, cutting-edge research, and technology to reach women where they are. We’re excited to support the launch of DARE to PLAY with tools that inform, engage, and uplift women navigating arousal concerns.” said Lyndsey Harper, MD, CEO and Founder of Rosy Wellness.

The campaign launching this week is the first step in Daré’s broader collaboration with Rosy Wellness, which will include healthcare provider (HCP)-focused awareness initiatives and support for DARE to PLAY customers. The partnership underscores a shared commitment to advancing sexual health equity and ensuring women have access to both the information and solutions they need. For more information, please visit www.meetrosy.com.

Daré is targeting DARE to PLAY Sildenafil Cream availability by prescription in the United States in the 4th quarter of 2025 as a compounded drug under Section 503B of the Federal Food, Drug, and Cosmetic ACT (FDCA).

To join the product alert list and be among the first to know when DARE to PLAY Sildenafil Cream becomes available by prescription, please visit https://daretoplaybio.com/

About Rosy Wellness

Rosy is a leading women's health platform dedicated to empowering women with evidence-based resources, expert support, and community connection, starting with sexual health and expanding across the full spectrum of the health of women. Founded by Lyndsey Harper, a board-certified OB-GYN, Rosy addresses long-overlooked aspects of women's care through an accessible digital platform that combines personalized education, self-guided tools, community, and health coaching.

Whether tackling issues like sexual dysfunction, menopause, migraine, or emotional well-being, Rosy provides judgment-free, medically backed support designed for real life. By combining evidence-based support with user-friendly technology, Rosy is redefining how women take charge of their health and experience more fulfilling lives.

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 the FDCA; the ability of DARE to PLAY™ Sildenafil Cream to provide a solution for women experiencing difficulties with sexual arousal; the market opportunity for the product and its ability to gain market acceptance; and the potential benefits of Daré’s collaboration with Rosy Wellness and the consumer awareness campaign relating to DARE to PLAY™ Sildenafil Cream. 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; 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; Daré’s ability to maintain compliance with Nasdaq’s continued listing requirements and continue to have its common stock listed on The Nasdaq Capital Market; 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

FAQ

When will DARE to PLAY Sildenafil Cream be available by prescription?

DARE to PLAY Sildenafil Cream is targeted to be available by prescription in the fourth quarter of 2025 in the United States.

What is DARE to PLAY Sildenafil Cream and how does it work?

DARE to PLAY is a topical formulation of sildenafil (the same active ingredient in Viagra) developed specifically for women, clinically shown to improve genital blood flow and sexual response.

How is Rosy Wellness involved in the DARE to PLAY launch?

Rosy Wellness, with its community of over 250,000 women, is partnering with Daré to provide educational content, including an Arousal Collection and Quickie videos, to raise awareness about women's arousal and DARE to PLAY.

What makes DARE to PLAY different from other products?

Unlike other untested compounded products, DARE to PLAY is backed by clinical evidence and specifically formulated to deliver sildenafil precisely where it can have its effect in women.

How can patients stay updated about DARE to PLAY's availability?

Interested patients can join the product alert list at daretoplaybio.com to be among the first to know when DARE to PLAY becomes available by prescription.