Preliminary Efficacy of Topical Sildenafil Cream for the Treatment of Female Sexual Arousal Disorder - A Randomized Controlled Trial
Isabella Johnson, MS, Andrea Ries Thurman, MD, Katherine A. Cornell, BS, Jessica Hatheway, MBA, Clint Dart, MS, C. Paige Brainard, MD, David R. Friend, PhD, and Andrew Goldstein, MD
Female sexual arousal disorder is a persistent or recurrent inability to attain, or to maintain until completion of the sexual activity, an adequate lubrication-swelling response of sexual excitement that causes marked distress or interpersonal diffi- culty.1,2 Despite the high prevalence of female sexual arousal disorder (about 20% of U.S. women3–5), to date there are no U.S. Food and Drug Administration (FDA)–approved pharmacologic treatments for female sexual arousal disorder.
Full Publication
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
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 3.6% (Sildenafil Cream), which is being developed for the treatment of female sexual arousal disorder (FSAD).
Full Article
Daré Bioscience Reports First Quarter 2024 Financial Results and Provides Company Update
SAN DIEGO, May 14, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in innovation for the health and wellbeing of women, today reported financial results for the quarter ended March 31, 2024 and provided a company update.
Full Article
Daré Bioscience Selected as a Member of ARPA-H Investor Catalyst Hub Spoke Network
SAN DIEGO, May 2, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, today announced it was selected as a spoke for the Investor Catalyst Hub, a regional hub of ARPANET-H, a nationwide health innovation network launched by the Advanced Research Projects Agency for Health (ARPA-H).
Full Article
Daré Bioscience Secures $22 Million in Non-Dilutive Strategic Royalty Financing to Advance Phase 3 First-in-Category Women’s Health Product Candidates through Key Catalysts
SAN DIEGO, April 30, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, today announced it has closed a royalty monetization transaction with XOMA (US) LLC. Daré received $22 million in gross proceeds at close and, following a pre-specified total return to XOMA, XOMA will make upside-sharing milestone payments to Daré equal to 50% of all remaining cash flows sold to XOMA under the transaction.
Full Article
Daré Bioscience Announces Additional Positive Data from Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women and Proposed Endpoints and Patient Population for Phase 3 Program
SAN DIEGO, Nov. 01, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, and its collaborator Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced additional positive findings based on further analyses of data from the exploratory Phase 2b RESPOND study that evaluated Sildenafil Cream, 3.6% (Sildenafil Cream) in women with female sexual arousal disorder (FSAD).
Full Article
Daré Bioscience Announces Positive Topline Data from the Exploratory Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women with Female Sexual Arousal Disorder
SAN DIEGO, June 05, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women's health innovation, and its
collaborator Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced positive
topline data from the exploratory Phase 2b RESPOND study evaluating topical Sildenafil Cream, 3.6% (Sildenafil Cream) as a treatment for female
sexual arousal disorder (FSAD). The exploratory study was designed to test the sensitivity of several patient reported outcome (PRO) efficacy
endpoints and their ability to determine a treatment effect of Sildenafil Cream compared to placebo to inform the ongoing development of Sildenafil
Cream. The study also served as a validation study of exploratory endpoints that could be candidate endpoints in a Phase 3 study of Sildenafil Cream.
Although the exploratory study was underpowered to assess statistical significance, certain endpoints achieved statistical significance.
Full Article
Daré Bioscience Announces Availability of Publication on the Patient-Centered Concept Elicitation Study for Female Sexual Arousal Disorder in The Journal of Sexual Medicine
SAN DIEGO, May 31, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, today
announced the publication of results of the patient-centered study designed to elucidate the commonly reported symptoms, including severity of
symptoms, associated with female sexual arousal disorder (FSAD). The publication, "Symptoms and associated impact in pre-and postmenopausal
women with sexual arousal disorder: a concept elicitation study," appears in The Journal of Sexual Medicine.
Full Article
Daré Bioscience Announces Interim Analysis of Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women with Female Sexual Arousal Disorder
SAN DIEGO, Aug. 29, 2022 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, and Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced that, based on the results of an interim analysis to evaluate the relative magnitude of the treatment effect, they expect to complete enrollment in the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% in 4Q-2022, allowing for a topline data announcement target of 2Q-2023. The interim analysis was conducted by an independent third-party statistical resource and both Daré and SST continue to remain blinded to results of the study by treatment group. The Phase 2b RESPOND clinical study is a multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of Sildenafil Cream, 3.6% in premenopausal patients with female sexual arousal disorder (FSAD).
Full Article
Daré Bioscience Announces Initiation of Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women with Female Sexual Arousal Disorder
SAN DIEGO, March 24, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, and Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced the initiation of the Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% for the treatment of female sexual arousal disorder (FSAD).
Full Article
Daré Bioscience Presents Positive Sildenafil Cream, 3.6% Data Supporting Further Development for the Treatment of Female Sexual Arousal Disorder
SAN DIEGO, March 09, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, today
announced the presentation of positive findings from a previously reported investigational study that used thermography technology to assess the
pharmacodynamics of Sildenafil Cream, 3.6% (Sildenafil Cream) in healthy women. The presentation was made at the International Society for the
Study of Women’s Sexual Health (ISSWSH) Annual Meeting 2020, which took place in Orlando, FL, March 5-8, 2020.
Full Article
Daré Bioscience Announces Alignment with the FDA on Phase 2b Study Design and Novel Primary Endpoint PRO Instruments to Support the Continued Clinical Development of Sildenafil Cream, 3.6%, a Potential Therapy for Female Sexual Arousal Disorder
SAN DIEGO, Dec. 11, 2019 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, and Strategic
Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced the outcome of a Type C meeting
with the U.S. Food and Drug Administration (FDA) where alignment was reached on the patient reported outcome (PRO) instruments to be used in a
Phase 2b clinical study of Sildenafil Cream, 3.6% (Sildenafil Cream) to screen eligible patients with Female Sexual Arousal Disorder (FSAD) and to
assess the efficacy of Sildenafil Cream in treating FSAD. The discussions with the FDA followed the completion of a content validity study of the
proposed PRO instruments, a non-interventional study integral to initiating the at-home, product dosing portion of the Sildenafil Cream Phase 2b
program.
Full Article
Daré Bioscience and Strategic Science & Technologies Announce Presentation of Positive Findings from Thermography Clinical Study of Sildenafil Cream, 3.6 % in Healthy Women at the Sexual Medicine Society of North America Conference
SAN DIEGO, Oct. 28, 2019 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, and Strategic
Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced a poster presentation at the
Sexual Medicine Society of North America 20th Annual Fall Scientific Meeting, which took place in Nashville, Tennessee, October 24-27, 2019. Daré,
in collaboration with SST, is developing Sildenafil Cream, 3.6% as a potential treatment for female sexual arousal disorder (FSAD).
Full Article
Daré Bioscience Announces Completion of its Content Validity Study to Support the Continued Clinical Development of Sildenafil Cream, 3.6%, a Potential Therapy for Female Sexual Arousal Disorder
SAN DIEGO, Sept. 09, 2019 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, and Strategic
Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced the completion of a content
validity study, a non-interventional study integral to initiating the at-home, product dosing portion of the Sildenafil Cream, 3.6% (Sildenafil Cream)
Phase 2b program. Daré plans to review the findings of the content validity study with the U.S. Food and Drug Administration (FDA) in a Type C
meeting and to seek alignment on the patient reported outcome (PRO) instruments to be used to screen eligible patients with Female Sexual Arousal
Disorder (FSAD) and to assess the efficacy of Sildenafil Cream in treating FSAD.
Full Article
Daré Bioscience, Inc. Announces Positive Results in Thermography Feasibility Study with Sildenafil Cream, 3.6%, a Potential Therapy for Female Sexual Arousal Disorder
SAN DIEGO, June 17, 2019 (GLOBE NEWSWIRE) - Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women's health innovation, today announced positive findings from an investigational study designed to evaluate the feasibility of using thermography technology to assess the pharmacodynamics of Sildenafil Cream, 3.6% (Sildenafil Cream) in normal healthy women.
Full Article
Strategic Science & Technologies & Daré announce Initiation of Content Validity Study for Sildenafil Cream, 3.6%
SAN DIEGO, Nov. 29, 2018 (GLOBE NEWSWIRE) - Daré Bioscience, Inc. (NASDAQ: DARE), a leader in clinical-stage women's health innovation, and SST, a Cambridge, MA based novel topical drug delivery company, today announced the initiation of a content validity study intended to support the use of specific patient reported outcome (PRO) measures to assess efficacy in female sexual arousal disorder (FSAD) patients in the Phase 2b and Phase 3 program for Sildenafil Cream, 3.6%.
Full Article
Strategic Science & Technologies & Daré Bioscience, Inc. Announces Enrollment in Thermography Feasibility Study with Sildenafil Cream, 3.6%
SAN DIEGO, Nov. 27, 2018 (GLOBE NEWSWIRE) - Daré Bioscience, Inc. (NASDAQ: DARE), a leader in clinical-stage women's health innovation, today announced that it is currently enrolling patients in an investigational study designed to evaluate the feasibility of using thermography technology to assess the pharmacodynamics of Sildenafil Cream, 3.6% in normal healthy women. Sildenafil, the active ingredient in Sildenafil Cream, 3.6%, is marketed in an oral dosage form under the brand name Viagra® for the treatment of erectile dysfunction in men. Daré Bioscience, in partnership with Strategic Science & Technologies, LLC (SST), is developing Sildenafil Cream, 3.6% as a potential treatment for female sexual arousal disorder (FSAD).
Full Article
Strategic Science & Technologies & DaréBioscience, Inc. Announces Effective License and Collaboration Agreement for Topical Sildenafil Cream, 3.6%
SAN DIEGO, Feb. 15, 2018 (GLOBE NEWSWIRE) - Daré Bioscience, Inc. (NASDAQ:DARE), a clinical-stage, women's biopharmaceutical company, today announced that it has met the funding requirement for obtaining an exclusive worldwide license to advance Sildenafil Citrate Cream 3.6%, a potential treatment for Female Sexual Arousal Disorder (FSAD).
Full Article
Strategic Science & Technologies & Daré Bioscience, Inc. Enters into License and Collaboration Agreement for a Potential First in Class Product
SAN DIEGO - February 12, 2018– Daré Bioscience, Inc. [NASDAQ: DARE], a clinical-stage, women's biopharmaceutical company, today announced it has entered into an agreement to license Sildenafil Cream, 3.6%, a potential treatment for Female Sexual Arousal Disorder (FSAD), from Strategic Science & Technologies, LLC. FSAD is characterized primarily by an inability to attain or maintain sufficient physical sexual arousal that causes distress or interpersonal difficulty.
Full Article
Strategic Science & Technologies Initiates Phase 2 Study to Evaluate Topical Sildenafil in Women with FSAD
CAMBRIDGE, Mass. - October 28, 2015 - Strategic Science & Technologies, a clinical stage biotechnology company developing known pharmaceutical products, announced the initiation of a Phase 2 clinical proof-of-concept trial of sildenafil cream, 3.6%, a first-in-class topical product candidate in development for the treatment of Female Sexual Arousal Disorder. The cream contains sildenafil citrate, the active drug component in Viagra®, which is currently marketed by Pfizer for the treatment of erectile dysfunction in men.
Full Article
Strategic Science & Technologies Initiates Phase 2 Study to Evaluate Topical Sildenafil in Men with ED
CAMBRIDGE, Mass. - June 17, 2015 - Strategic Science & Technologies LLC, a clinical stage biotechnology company developing novel first-in-class topical formulations of known pharmaceutical products, announced the initiation of a Phase 2 trial of topical sildenafil for men with erectile dysfunction. The oral formulation of sildenafil is marketed by Pfizer as Viagra®.
Full Article
Strategic Science & Technologies Announces Completion of Phase 1 Trial for a First-in-Class Treatment for Female Sexual Arousal Disorder
CAMBRIDGE, Mass. - May 15, 2015 - Strategic Science & Technologies LLC, a clinical-stage biotechnology company developing novel first-in-class topical formulations of known pharmaceutical products, announced today the successful completion of a Phase 1 clinical trial of sildenafil cream, 3.6%, the Company's first-in-class topical sildenafil product candidate in development for the treatment of female sexual arousal disorder.
Full Article
