Daré Bioscience Announces Publication in The Journal of Sexual Medicine of Positive Safety Findings from the Phase 2b RESPOND Clinical Study of Sildenafil Cream, 3.6%
Daré Bioscience (NASDAQ: DARE) announced the publication of safety data from its Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% in The Journal of Sexual Medicine. The study, involving 1,357 sexual experiences, showed that the topical cream was safe and well-tolerated by women with female sexual arousal disorder (FSAD) and their partners. Notably, the cream did not produce common side effects associated with oral sildenafil, such as headache and flushing. This is likely due to the hundred-fold lower systemic exposure compared to oral dosing. The study was designed to identify the most responsive patient population and appropriate patient-reported outcome measures for future Phase 3 trials. Daré is currently in discussions with the FDA regarding the development program for Sildenafil Cream as an FSAD treatment.
Daré Bioscience (NASDAQ: DARE) ha annunciato la pubblicazione dei dati di sicurezza del suo studio clinico di fase 2b RESPOND riguardante la Crema di Sildenafil, 3,6%, sulla rivista The Journal of Sexual Medicine. Lo studio, che ha coinvolto 1.357 esperienze sessuali, ha dimostrato che la crema topica è stata sicura e ben tollerata da donne con disturbo dell'eccitazione sessuale femminile (FSAD) e dai loro partner. È interessante notare che la crema non ha prodotto gli effetti collaterali comuni associati al sildenafil orale, come mal di testa e arrossamento. Questo è probabilmente dovuto all'esposizione sistemica cento volte inferiore rispetto al dosaggio orale. Lo studio è stato progettato per identificare la popolazione di pazienti più reattiva e le misure di esito riportate dai pazienti appropriate per i futuri studi di fase 3. Daré è attualmente in discussione con la FDA riguardo il programma di sviluppo della Crema di Sildenafil come trattamento per FSAD.
Daré Bioscience (NASDAQ: DARE) anunció la publicación de datos de seguridad de su estudio clínico de fase 2b RESPOND sobre la Crema de Sildenafil, 3.6%, en The Journal of Sexual Medicine. El estudio, que involucró 1,357 experiencias sexuales, mostró que la crema tópica fue segura y bien tolerada por mujeres con trastorno de excitación sexual femenina (FSAD) y sus parejas. Notablemente, la crema no produjo los efectos secundarios comunes asociados con el sildenafil oral, como dolores de cabeza y enrojecimiento. Esto se debe probablemente a la exposición sistémica cien veces menor en comparación con la dosificación oral. El estudio fue diseñado para identificar la población de pacientes más receptiva y las medidas de resultado informadas por los pacientes adecuadas para futuros ensayos de fase 3. Daré está actualmente en conversaciones con la FDA sobre el programa de desarrollo de la Crema de Sildenafil como tratamiento para FSAD.
Daré 바이오사이언스 (NASDAQ: DARE)는 성의학 저널에 Sildenafil 크림 3.6%의 2b 단계 RESPOND 임상 연구의 안전성 데이터 발표를 알렸습니다. 1,357개의 성적 경험을 포함한 이 연구는 국소 크림이 여성 성적 흥분 장애(FSAD)를 가진 여성과 그들의 파트너에게 안전하고 잘 견뎌졌다는 결과를 보였습니다. 특히, 이 크림은 구강용 실데나필과 관련된 두통 및 얼굴 홍조와 같은 일반적인 부작용을 발생시키지 않았습니다. 이는 구강 복용에 비해 백배 낮은 전신 노출로 인한 것으로 보입니다. 이 연구는 가장 반응을 잘 보이는 환자 집단과 향후 3기 임상 시험을 위한 적합한 환자 보고 결과 측정을 식별하기 위해 설계되었습니다. Daré는 현재 FSAD 치료를 위한 실데나필 크림의 개발 프로그램에 대해 FDA와 논의 중입니다.
Daré Bioscience (NASDAQ: DARE) a annoncé la publication de données de sécurité de son étude clinique de phase 2b RESPOND concernant la crème de sildénafil à 3,6% dans The Journal of Sexual Medicine. L'étude, impliquant 1 357 expériences sexuelles, a montré que la crème topique était sans danger et bien tolérée par les femmes atteintes de trouble de l'excitation sexuelle féminine (FSAD) et leurs partenaires. Il est à noter que la crème n'a pas produit les effets secondaires courants associés au sildénafil oral, tels que maux de tête et rougissement. Cela est probablement dû à une exposition systémique cent fois inférieure par rapport à l'administration orale. L'étude a été conçue pour identifier la population de patients la plus réceptive et les mesures de résultats rapportées par les patients appropriées pour les futurs essais de phase 3. Daré est actuellement en discussion avec la FDA concernant le programme de développement de la crème de sildénafil en tant que traitement du FSAD.
Daré Bioscience (NASDAQ: DARE) hat die Veröffentlichung von Sicherheitsdaten aus seiner Phase 2b RESPOND-Klinikstudie zur Sildenafil-Creme 3,6% im The Journal of Sexual Medicine angekündigt. Die Studie, die 1.357 sexuelle Erfahrungen umfasste, zeigte, dass die topische Creme für Frauen mit Störung der sexuellen Erregung (FSAD) und deren Partner sicher und gut verträglich war. Bemerkenswert ist, dass die Creme keine häufigen Nebenwirkungen verursachte, die mit oralem Sildenafil verbunden sind, wie Kopfschmerzen und Gesichtsrötung. Dies ist wahrscheinlich auf die hundertmal niedrigere systemische Exposition im Vergleich zur oralen Dosierung zurückzuführen. Die Studie wurde entwickelt, um die am besten ansprechbare Patientengruppe und geeignete von Patienten berichtete Ergebnisse für zukünftige Phase-3-Studien zu identifizieren. Daré führt derzeit Gespräche mit der FDA über das Entwicklungsprogramm für die Sildenafil-Creme als FSAD-Behandlung.
- Positive safety profile demonstrated in Phase 2b RESPOND study
- No common side effects associated with oral sildenafil observed
- Hundred-fold lower systemic exposure compared to oral dosing
- Identified responsive patient population for Phase 3 trials
- Ongoing interactions with FDA for development program
- Study not powered to show statistically significant differences in adverse events
Insights
The publication of safety data for Sildenafil Cream, 3.6% in The Journal of Sexual Medicine is a significant milestone for Daré Bioscience. The study's findings, showing favorable safety and tolerability across
Key points:
- Absence of common side effects associated with oral sildenafil (headache, flushing)
- Hundred-fold lower systemic exposure compared to oral dosing
- Well-tolerated by both patients and partners
While these results are promising, it's important to note that the study wasn't powered for statistical significance in adverse events. The next critical step will be the planned Phase 3 program, which will provide more definitive efficacy and safety data.
This news could have a positive impact on Daré Bioscience's market position. The female sexual health market is underserved and a safe, effective treatment for FSAD could be a game-changer. Key considerations:
- Potential first-in-class topical treatment for FSAD
- Addressing an unmet medical need in women's health
- Favorable safety profile could lead to higher patient acceptance
However, investors should note that the path to market still involves the important Phase 3 trials and FDA approval. The company's ongoing interactions with the FDA and operational preparations for Phase 3 suggest confidence in the product's potential, but success is not guaranteed. The market will likely watch closely for updates on the Phase 3 program timeline and design.
While this news is positive for Daré Bioscience (NASDAQ: DARE), its financial impact may be in the short term. Key financial considerations:
- R&D expenses likely to increase with upcoming Phase 3 trials
- No immediate revenue impact; commercialization still years away
- Potential for partnerships or licensing deals could increase with positive data
Investors should focus on the company's cash position and burn rate as it prepares for costly Phase 3 trials. The positive safety data may enhance the company's ability to secure funding or partnerships, which could be important for long-term value creation. However, as a small-cap biotech, DARE remains a high-risk, high-reward investment, with its value largely tied to the success of its pipeline products, including Sildenafil Cream, 3.6%.
Published data show that topical Sildenafil Cream,
Use of topical Sildenafil Cream,
SAN DIEGO, Aug. 26, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, today announced that safety and tolerability data from the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream,
Publication Details:
Thurman, et al. “Safety of topical sildenafil cream,
“We were very pleased to see a favorable safety and tolerability profile from both patients and their partners in this study,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “This is a particularly robust safety dataset since it includes assessments of both the participants and their partners.”
“Topical sildenafil cream was well tolerated in this study,” said Dr. Annie Thurman, MD, FACOG, lead author of the publication and Medical Director at Daré Bioscience. “Because oral sildenafil has known hypotensive effects, we were watching for related side effects such as headache, flushing, nausea, and dizziness. In the RESPOND study with our topical application, however, we did not see these effects, likely due to the hundred-fold lower systemic exposure as compared to oral dosing of sildenafil.”
The exploratory Phase 2b RESPOND study evaluated the systemic and local genital safety of Sildenafil Cream,
As previously announced, efficacy data from the Phase 2b RESPOND study were published in Obstetrics & Gynecology, the official publication of the American College of Obstetricians and Gynecologists. The journal article, entitled “Preliminary Efficacy of Topical Sildenafil Cream for the Treatment of Female Sexual Arousal Disorder: A Randomized Controlled Trial,” can be found in the August 2024 issue of Obstetrics & Gynecology 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.
About FSAD and Sildenafil Cream,
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.
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, well-tolerated and effective therapy for FSAD, Daré’s 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 “first-in-category” 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 Daré is developing it. 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 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 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 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:
Daré Bioscience Investor Relations
innovations@darebioscience.com
Source: Daré Bioscience, Inc.
FAQ
What were the key findings of Daré Bioscience's Phase 2b RESPOND study for Sildenafil Cream, 3.6%?
How does the systemic exposure of Sildenafil Cream, 3.6% compare to oral sildenafil?
What is the current status of Sildenafil Cream, 3.6% development for FSAD treatment?
Where were the safety findings from the RESPOND study published?
