{"id":749512,"date":"2023-04-20T08:34:25","date_gmt":"2023-04-20T12:34:25","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-initiation-of-subject-enrollment-in-a-phase-1-thermography-study-to-support-pharmacodynamic-and-pharmacokinetic-characterization-of-sildenafil-cream-3-6\/"},"modified":"2023-04-20T08:34:25","modified_gmt":"2023-04-20T12:34:25","slug":"dare-bioscience-announces-initiation-of-subject-enrollment-in-a-phase-1-thermography-study-to-support-pharmacodynamic-and-pharmacokinetic-characterization-of-sildenafil-cream-3-6","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-initiation-of-subject-enrollment-in-a-phase-1-thermography-study-to-support-pharmacodynamic-and-pharmacokinetic-characterization-of-sildenafil-cream-3-6\/","title":{"rendered":"Dar\u00e9 Bioscience Announces Initiation of Subject Enrollment in a Phase 1 Thermography Study to Support Pharmacodynamic and Pharmacokinetic Characterization of Sildenafil Cream, 3.6%"},"content":{"rendered":"
\n

\n Phase 1 Thermography Study Quantitative Data Expected to Complement Patient Reported Outcome Data Collected in the Exploratory Phase 2b RESPOND At-Home Study<\/strong>
\n \n <\/p>\n

\n Topline Data for the Exploratory Phase 2b RESPOND Study Anticipated in 2Q-2023<\/strong>\n <\/p>\n

SAN DIEGO, April 20, 2023 (GLOBE NEWSWIRE) — Dar\u00e9 Bioscience, Inc. (NASDAQ: DARE), a leader in women\u2019s health innovation, and Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced initiation of screening and enrollment for a Phase 1 clinical study using thermography to assess the pharmacodynamic and pharmacokinetic characterization of Sildenafil Cream, 3.6% (Sildenafil Cream), a late-stage product candidate being developed as a potential new treatment for female sexual arousal disorder (FSAD). The quantitative pharmacokinetic and pharmacodynamic temperature data captured in a clinic setting in the study are expected to complement the patient reported outcome data collected in the ongoing Phase 2b RESPOND study, where the women use Sildenafil Cream in their home setting.<\/p>\n

FSAD is the inability to reach or maintain a sufficient physical response to sexual stimulation and, of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction (ED) in men. Sildenafil is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra\u00ae<\/sup> for the treatment of ED in men. Sildenafil Cream is an investigational proprietary topical cream formulation specifically designed to increase blood flow to the genital tissue in women. If successful, Sildenafil Cream has the potential to be the first FDA-approved treatment for FSAD.<\/p>\n

\u201cThis Phase 1, single-dose, double-blind, placebo-controlled, 3-way crossover study will utilize thermography to assess the pharmacodynamics and pharmacokinetics Sildenafil Cream in comparison with versions of the cream without the active ingredient, sildenafil,\u201d said Andrea Thurman, MD, Medical Director for Dar\u00e9 Bioscience. \u201cThe findings from this study, specifically the pharmacodynamic and pharmacokinetic data, are an important part of our comprehensive clinical development and regulatory plan for Sildenafil Cream and will add to our existing clinical and nonclinical data package to support the ongoing development program.\u201d<\/p>\n

During the thermography study, vulvar temperature, a surrogate for vulvar blood flow, will be recorded by thermography in a clinic setting. Increasing blood flow to the genital tissue, as Sildenafil Cream is designed to do, has the potential to improve genital arousal response and overall sexual experience for women. Unlike the oral formulations of PDE-5 inhibitors, Sildenafil Cream is designed to be applied locally to the vaginal tissue prior to sexual activity to facilitate vasodilation and increase blood flow directly to the genital tissue to improve the physical arousal response to address the lack of those genital arousal sensations commonly associated with FSAD.<\/p>\n

\u201cWe are excited to announce that enrollment is underway in this important supplemental thermography study,\u201d said Sabrina Martucci Johnson, President & CEO of Dar\u00e9 Bioscience. \u201cThis study has the potential to provide additional quantitative data regarding the ability of our cream formulation of the active ingredient sildenafil to increase genital blood flow, as assessed by vulvar temperature. These data are expected to complement forthcoming clinical findings from our Phase 2b RESPOND trial in preparation for a Phase 3 program.\u201d<\/p>\n

The Phase 1 thermography study of Sildenafil Cream is expected to enroll approximately 15 women and be completed in 2023.<\/p>\n

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

Dar\u00e9\u2019s first FDA-approved product, XACIATO\u2122 (clindamycin phosphate) vaginal gel, 2% is 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. XACIATO is a clear, colorless, viscous gel, to be administered once intravaginally as a single dose. Dar\u00e9\u2019s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene\u00ae<\/sup>, 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 to treat female sexual arousal disorder utilizing the active ingredient in Viagra\u00ae<\/sup>; 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<\/a>.<\/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<\/a>), 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 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

\n Forward-Looking Statements<\/strong>\n <\/p>\n

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 anticipated timing of topline data from the Phase 2b RESPOND study of Sildenafil Cream, expectations regarding the Phase 1 thermography study of Sildenafil Cream, and the potential for Sildenafil Cream to be the first FDA-approved treatment for FSAD. 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, risk 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; 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 risk that development of a product candidate requires more clinical or nonclinical studies than Dar\u00e9 anticipates, or that the duration of a study or number of study subjects must be significantly greater than anticipated; 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 loss of, or inability to attract, key personnel; the effects of the COVID-19 pandemic, macroeconomic conditions such as inflation, rising interest rates and geopolitical events on Dar\u00e9\u2019s operations, financial results and condition, and ability to achieve current plans and objectives, including the potential impact of the pandemic on Dar\u00e9\u2019s ability to timely commence, enroll, conduct and report results of its clinical trials and on the ability of third parties on which Dar\u00e9 relies to assist in the conduct of its business to fulfill their contractual obligations to Dar\u00e9; 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; cyber attacks, security breaches 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:<\/p>\n

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

Lee Roth<\/p>\n

Burns McClellan<\/p>\n

\n lroth@burnsmc.com<\/a>\n <\/p>\n

646.930.4406<\/p>\n

OR<\/p>\n

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

Jake Robison<\/p>\n

Evoke Canale<\/p>\n

\n jake.robison@evokegroup.com<\/a>\n <\/p>\n

619.849.5383<\/p>\n

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


\n
\n \n <\/div>\n

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

Phase 1 Thermography Study Quantitative Data Expected to Complement Patient Reported Outcome Data Collected in the Exploratory Phase 2b RESPOND At-Home Study Topline Data for the Exploratory Phase 2b RESPOND Study Anticipated in 2Q-2023 SAN DIEGO, April 20, 2023 (GLOBE NEWSWIRE) — Dar\u00e9 Bioscience, Inc. (NASDAQ: DARE), a leader in women\u2019s health innovation, and Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced initiation of screening and enrollment for a Phase 1 clinical study using thermography to assess the pharmacodynamic and pharmacokinetic characterization of Sildenafil Cream, 3.6% (Sildenafil Cream), a late-stage product candidate being developed as a potential new treatment for female sexual arousal disorder (FSAD). The quantitative pharmacokinetic and pharmacodynamic temperature … <\/p>\n

Continue reading “Dar\u00e9 Bioscience Announces Initiation of Subject Enrollment in a Phase 1 Thermography Study to Support Pharmacodynamic and Pharmacokinetic Characterization of Sildenafil Cream, 3.6%”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-749512","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nDar\u00e9 Bioscience Announces Initiation of Subject Enrollment in a Phase 1 Thermography Study to Support Pharmacodynamic and Pharmacokinetic Characterization of Sildenafil Cream, 3.6% - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-initiation-of-subject-enrollment-in-a-phase-1-thermography-study-to-support-pharmacodynamic-and-pharmacokinetic-characterization-of-sildenafil-cream-3-6\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dar\u00e9 Bioscience Announces Initiation of Subject Enrollment in a Phase 1 Thermography Study to Support Pharmacodynamic and Pharmacokinetic Characterization of Sildenafil Cream, 3.6% - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Phase 1 Thermography Study Quantitative Data Expected to Complement Patient Reported Outcome Data Collected in the Exploratory Phase 2b RESPOND At-Home Study Topline Data for the Exploratory Phase 2b RESPOND Study Anticipated in 2Q-2023 SAN DIEGO, April 20, 2023 (GLOBE NEWSWIRE) — Dar\u00e9 Bioscience, Inc. 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-initiation-of-subject-enrollment-in-a-phase-1-thermography-study-to-support-pharmacodynamic-and-pharmacokinetic-characterization-of-sildenafil-cream-3-6\/","og_locale":"en_US","og_type":"article","og_title":"Dar\u00e9 Bioscience Announces Initiation of Subject Enrollment in a Phase 1 Thermography Study to Support Pharmacodynamic and Pharmacokinetic Characterization of Sildenafil Cream, 3.6% - Market Newsdesk","og_description":"Phase 1 Thermography Study Quantitative Data Expected to Complement Patient Reported Outcome Data Collected in the Exploratory Phase 2b RESPOND At-Home Study Topline Data for the Exploratory Phase 2b RESPOND Study Anticipated in 2Q-2023 SAN DIEGO, April 20, 2023 (GLOBE NEWSWIRE) — Dar\u00e9 Bioscience, Inc. (NASDAQ: DARE), a leader in women\u2019s health innovation, and Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced initiation of screening and enrollment for a Phase 1 clinical study using thermography to assess the pharmacodynamic and pharmacokinetic characterization of Sildenafil Cream, 3.6% (Sildenafil Cream), a late-stage product candidate being developed as a potential new treatment for female sexual arousal disorder (FSAD). The quantitative pharmacokinetic and pharmacodynamic temperature … Continue reading \"Dar\u00e9 Bioscience Announces Initiation of Subject Enrollment in a Phase 1 Thermography Study to Support Pharmacodynamic and Pharmacokinetic Characterization of Sildenafil Cream, 3.6%\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-initiation-of-subject-enrollment-in-a-phase-1-thermography-study-to-support-pharmacodynamic-and-pharmacokinetic-characterization-of-sildenafil-cream-3-6\/","og_site_name":"Market Newsdesk","article_published_time":"2023-04-20T12:34:25+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODgxMTgwNyM1NTM3MDI4IzIwMDgzNjQ=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"9 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-initiation-of-subject-enrollment-in-a-phase-1-thermography-study-to-support-pharmacodynamic-and-pharmacokinetic-characterization-of-sildenafil-cream-3-6\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-initiation-of-subject-enrollment-in-a-phase-1-thermography-study-to-support-pharmacodynamic-and-pharmacokinetic-characterization-of-sildenafil-cream-3-6\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Dar\u00e9 Bioscience Announces Initiation of Subject Enrollment in a Phase 1 Thermography Study to Support Pharmacodynamic and Pharmacokinetic Characterization of Sildenafil Cream, 3.6%","datePublished":"2023-04-20T12:34:25+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-initiation-of-subject-enrollment-in-a-phase-1-thermography-study-to-support-pharmacodynamic-and-pharmacokinetic-characterization-of-sildenafil-cream-3-6\/"},"wordCount":1766,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-initiation-of-subject-enrollment-in-a-phase-1-thermography-study-to-support-pharmacodynamic-and-pharmacokinetic-characterization-of-sildenafil-cream-3-6\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODgxMTgwNyM1NTM3MDI4IzIwMDgzNjQ=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-initiation-of-subject-enrollment-in-a-phase-1-thermography-study-to-support-pharmacodynamic-and-pharmacokinetic-characterization-of-sildenafil-cream-3-6\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/dare-bioscience-announces-initiation-of-subject-enrollment-in-a-phase-1-thermography-study-to-support-pharmacodynamic-and-pharmacokinetic-characterization-of-sildenafil-cream-3-6\/","name":"Dar\u00e9 Bioscience Announces Initiation of Subject Enrollment in a Phase 1 Thermography Study to Support Pharmacodynamic and Pharmacokinetic Characterization of Sildenafil Cream, 3.6% - 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