{"id":58252,"date":"2024-08-13T12:03:57","date_gmt":"2024-08-13T12:03:57","guid":{"rendered":"https:\/\/english.saigonbiz.com.vn\/2024\/08\/13\/dare-bioscience-announces-publication-in-the-journal-of-sexual-medicine-of-positive-findings-from-the-phase-2b-respond-clinical-study-of-sildenafil-cream-3-6\/"},"modified":"2024-08-13T12:03:57","modified_gmt":"2024-08-13T12:03:57","slug":"dare-bioscience-announces-publication-in-the-journal-of-sexual-medicine-of-positive-findings-from-the-phase-2b-respond-clinical-study-of-sildenafil-cream-3-6","status":"publish","type":"post","link":"https:\/\/english.saigonbiz.com\/vn\/dare-bioscience-announces-publication-in-the-journal-of-sexual-medicine-of-positive-findings-from-the-phase-2b-respond-clinical-study-of-sildenafil-cream-3-6\/","title":{"rendered":"Dar\u00e9 Bioscience Announces Publication in The Journal of Sexual Medicine of Positive Findings from the Phase 2b RESPOND Clinical Study of Sildenafil Cream, 3.6%"},"content":{"rendered":"
\n

Published data show that responses from 1-month and 24-hour recall patient reported outcome (PRO) instruments were similar and support that either method could be used to assess treatment efficacy in future clinical studies<\/strong><\/p>\n

Longer recall intervals for PRO assessments are less burdensome to clinical study participants and may improve data collection compliance<\/strong><\/p>\n

SAN DIEGO, Aug. 13, 2024 (GLOBE NEWSWIRE) — Dare\u0301\u00a0Bioscience, Inc.\u00a0(NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, today announced that additional data from the exploratory Phase 2b RESPOND clinical 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), has been published by The Journal of Sexual Medicine<\/em>.<\/p>\n

Publication Details:<\/p>\n

Johnson, et al. \u201cComparisons and correlations of 1-month recall vs 24-hour recall in patient-reported outcomes of an exploratory, phase 2b, randomized, double-blind, placebo-controlled clinical trial of sildenafil cream, 3.6% for the treatment of female sexual arousal disorder.\u201d The Journal of Sexual Medicine, 2024<\/em> [Preprint] https:\/\/doi.org\/10.1093\/jsxmed\/qdae086<\/a><\/p>\n

\u201cIn this first-of-its-kind study in FSAD patients, we are very pleased to be able to share these data,\u201d said Sabrina Martucci Johnson, President and CEO of Dar\u00e9 Bioscience. \u201cBeing able to show consistent results from patient reported outcome measures, regardless of whether she is recalling her experiences over the last month or the last day, provides important optionality as we consider how to clinically measure the impact of Sildenafil Cream on patients with FSAD.\u201d<\/p>\n

\u201cThis preplanned subset analysis was intended to investigate whether there were differences in outcomes when assessing arousal sensation on 24-hour vs 1-month PRO instruments,\u201d said Dr. Annie Thurman, MD, FACOG, Medical Director at Dare\u0301 Bioscience. \u201cWe were thrilled to see the strong correlation between the 24-hour recall eDiary and the 1-month recall instrument scores since the 1-month recall is significantly less burdensome for patients. With a condition that\u2019s often dismissed and stigmatized, it’s important to show that we can collect accurate data to assess efficacy of Sildenafil Cream in a way that\u2019s easily manageable for patients.\u201d<\/p>\n

The exploratory Phase 2b RESPOND study was specifically designed to identify the patient population that experienced the most meaningful improvement from Sildenafil Cream and the questions to ask them, or the PRO measures, that best reflect that improvement. The patient population and the endpoints proposed to the U.S. Food and Drug Administration (FDA) for Phase 3 clinical development were those where Dar\u00e9’s exploratory post-hoc analyses of the Phase 2b study data showed that Sildenafil Cream demonstrated statistically significant and meaningful patient improvement. Dar\u00e9 previously announced a positive end-of-Phase 2 meeting with the FDA supporting advancement of Sildenafil Cream for the treatment of FSAD and continues to interact with the FDA on the development program for Sildenafil Cream as a treatment for FSAD.<\/p>\n

As previously announced, efficacy data from the Phase 2b RESPOND study were published in Obstetrics & Gynecology<\/em>, the official publication of the American College of Obstetricians and Gynecologists. The journal article, entitled \u201cPreliminary Efficacy of Topical Sildenafil Cream for the Treatment of Female Sexual Arousal Disorder: A Randomized Controlled Trial,\u201d can be found in the August 2024 issue of Obstetrics & Gynecology<\/em> 144(2):p 144-152, and is available online at https:\/\/journals.lww.com\/greenjournal\/fulltext\/2024\/08000\/preliminary_efficacy_of_topical_sildenafil_cream.4.aspx<\/a>.<\/p>\n

About FSAD and Sildenafil Cream, 3.6%<\/strong><\/p>\n

FSAD, as described in the DSM-IV, is a condition characterized 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. 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.<\/p>\n

Sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra\u00ae 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.<\/p>\n

Market research suggests that 16% of women in the U.S. ages 21 to 60, or approximately 10 million women, are distressed from experiencing symptoms associated with FSAD, including lack of or low sexual arousal, and are actively seeking solutions to improve their condition. In comparison, the prevalence of complete ED in men is estimated to be about 5% of men at age 40, increasing to about 15% at age 70.<\/p>\n

About Dar\u00e9 Bioscience<\/strong><\/p>\n

Dar\u00e9 Bioscience is a biopharmaceutical company committed to advancing innovative products for women\u2019s health. The company\u2019s 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.<\/p>\n

The first FDA-approved product to emerge from Dar\u00e9\u2019s portfolio of women\u2019s 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. Organon commenced U.S. marketing of XACIATO in the fourth quarter of 2023. Dar\u00e9\u2019s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene\u00ae, 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, the active ingredient in Viagra\u00ae, 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 XACIATO, Dar\u00e9\u2019s full portfolio of women\u2019s health product candidates, and Dar\u00e9\u2019s mission to deliver differentiated therapies for women, please visit www.darebioscience.com.<\/p>\n

Dar\u00e9 Bioscience leadership has been named on the Medicine Maker\u2019s Power List and Endpoints News\u2019 Women in Biopharma 2022. In 2023, Dar\u00e9’s CEO was honored as one of Fierce Pharma\u2019s Most Influential People in Biopharma for Dar\u00e9\u2019s contributions to innovation and advocacy in the women\u2019s health space. Dar\u00e9 Bioscience placed #1 in the Small Company category of the San Diego Business Journal\u2019s 2023 Best Places to Work Awards.<\/p>\n

Dar\u00e9 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. Dar\u00e9 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 Dar\u00e9 posts on its investor relations website or through social media channels may be deemed to be material information. Dar\u00e9 encourages investors, the media, and others interested in the company to review the information Dar\u00e9 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 Dar\u00e9\u2019s website.<\/p>\n

Forward-Looking Statements<\/strong>
Dar\u00e9 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 \u201cbelieve,\u201d \u201cmay,\u201d \u201cwill,\u201d \u201cestimate,\u201d \u201ccontinue,\u201d \u201canticipate,\u201d \u201cdesign,\u201d \u201cintend,\u201d \u201cexpect,\u201d \u201ccould,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cpredict,\u201d \u201cseek,\u201d \u201cshould,\u201d \u201cwould,\u201d \u201ccontemplate,\u201d \u201cproject,\u201d \u201ctarget,\u201d \u201cobjective,\u201d 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\u2019s potential as a safe and effective therapy for FSAD, Dar\u00e9\u2019s plans for continued clinical development of Sildenafil Cream, including Phase 3 clinical trial design, the potential for Sildenafil Cream to be the first FDA-approved treatment for FSAD, and the potential market opportunity for Sildenafil Cream. As used in this press release, the description of a product candidate as \u201cfirst-in-category\u201d is a forward-looking statement relating to the potential of the candidate to represent a new category of product if it were to receive marketing approval for the indication for which Dar\u00e9 is developing it. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Dar\u00e9\u2019s 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: Dar\u00e9\u2019s 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 RESPOND 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 Dar\u00e9\u2019s 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 Dar\u00e9 anticipates; Dar\u00e9\u2019s 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; Dar\u00e9\u2019s 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; Dar\u00e9\u2019s 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 Dar\u00e9\u2019s operations, financial results and condition, and ability to achieve current plans and objectives; the risk that developments by competitors make Dar\u00e9\u2019s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and\/or commercial collaborators; failure of Dar\u00e9\u2019s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage or reimbursement from third-party payers; Dar\u00e9\u2019s ability to retain its licensed rights to develop and commercialize a product or product candidate; Dar\u00e9\u2019s 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; Dar\u00e9\u2019s ability to adequately protect or enforce its, or its licensor\u2019s, intellectual property rights; the lack of patent protection for the active ingredients in certain of Dar\u00e9\u2019s 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 Dar\u00e9\u2019s product or product candidates or the business activities of Dar\u00e9, its commercial collaborators or other third parties on which Dar\u00e9 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 Dar\u00e9\u2019s technology systems or those of third parties on which it relies and\/or significantly disrupt Dar\u00e9\u2019s business; and disputes or other developments concerning Dar\u00e9\u2019s intellectual property rights. Dar\u00e9\u2019s 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 Dar\u00e9\u2019s risks and uncertainties, you are encouraged to review its documents filed with the SEC including Dar\u00e9\u2019s 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. Dar\u00e9 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.<\/p>\n

Contacts:<\/strong><\/p>\n

Media and Investors on behalf of Dar\u00e9 Bioscience, Inc:<\/strong><\/p>\n

Camilla White \/ Simona Kormanikova
Dentons Global Advisors
DareBioscience@dentonsglobaladvisors.com \/ 1.212.466.6450<\/p>\n

Source: Dar\u00e9 Bioscience, Inc.<\/p>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

Published data show that responses from 1-month and 24-hour recall patient reported outcome (PRO) instruments were similar and support that either method could be used to assess treatment efficacy in future clinical studies Longer recall intervals for PRO assessments are less burdensome to clinical study participants and may improve data collection compliance SAN DIEGO, Aug. 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