{"id":27674,"date":"2019-10-11T08:00:41","date_gmt":"2019-10-11T08:00:41","guid":{"rendered":"https:\/\/www.edrugstore.com\/blog\/?p=27674"},"modified":"2019-10-09T11:55:56","modified_gmt":"2019-10-09T11:55:56","slug":"company-seeks-fda-approval-for-sildenafil-cream-for-women","status":"publish","type":"post","link":"https:\/\/www.edrugstore.com\/blog\/erectile-dysfunction\/viagra\/company-seeks-fda-approval-for-sildenafil-cream-for-women\/","title":{"rendered":"Company Seeks FDA Approval for Sildenafil Cream for Women"},"content":{"rendered":"

\u201cFemale Viagra\u201d may soon come in the form of a topical cream.<\/em><\/p>\n

Dar\u00e9 Bioscience, Inc. and Strategic Science & Technologies, LLC are moving forward\u00a0<\/a>with presenting their clinical trial plan to the FDA, with hopes of commencing Phase 2b of Sildenafil Cream, 3.6% (Sildenafil Cream) trials by the end of 2019. Sildenafil is the active ingredient in Viagra and has been studied for the purpose of treating Female Sexual Arousal Disorder (FSAD)<\/a>. It seems that Sildenafil Cream may become the first FDA-approved medication on the market for treating FSAD.<\/p>\n

An estimated 10 million women experience distress related to FSAD<\/a> in the United States, making this a groundbreaking treatment option if approved by the FDA. Read ahead for the answers to questions everyone is asking about the release of Sildenafil Cream.<\/p>\n

What\u2019s so Unique About Sildenafil Cream?<\/strong><\/h3>\n

Sildenafil would be the first treatment specifically approved to treat FSAD. Unlike other forms of sexual arousal disorders, FSAD is characterized by<\/a> an inability to attain or maintain sufficient physical response to sexual stimulation. While a limited number of products currently exist to treat issues pertaining to desire, such as Hypoactive (low) Sexual Desire Disorder (HSDD), Sildenafil Cream potentially treats issues related to physiological arousal<\/a>.<\/p>\n

\"Red<\/p>\n

How Does Sildenafil Cream Work?<\/strong><\/h3>\n

Sildenafil<\/a>, the active ingredient in both Viagra and Sildenafil Cream, works by increasing local blood flow and potentially improving genital arousal response and overall sexual experience for women.<\/p>\n

Orally administered sildenafil has not demonstrated effectiveness in treating FSAD<\/a>. However, topically administered sildenafil has shown to be effective in improving local blood flow<\/a> to the genital area. An initial Phase 2a sample of healthy women demonstrated significant success at improving blood flow, supporting the ongoing evaluation of Sildenafil Cream in larger trials<\/a>.<\/p>\n

What Are the Next Steps for\u00a0<\/strong>the Developers?\u00a0<\/strong><\/h3>\n

In order to obtain approval for the release of Sildenafil Cream<\/a>, the company will have to complete Phases 2 and 3 of clinical trials and will have to proceed with regulatory filing with the FDA.<\/p>\n

Phase 2b of the clinical trials<\/a> will evaluate the comparison of FSAD symptom relief between candidates using a placebo and candidates using Sildenafil Cream in their home setting. Findings from the 2a trial<\/a> and the comprehensive plan for Phase 2b implementation will be reviewed in a Category C meeting with the FDA by the end of 2019. Phase 2b should commence by the end of 2019, which could give way to Phase 3 beginning soon after.<\/p>\n

When Can We Expect to See Sildenafil Cream on the Market?<\/strong><\/h3>\n

The CEO of Dar\u00e9 Bioscience, Inc. stated the company was happy with Phase 2a trial results and was hopeful that Phase 2b of Sildenafil Cream trials<\/a> would commence by the end of 2019. In fact, the company was optimistic enough to share their current standing and projected progress at the H.C. Wainwright 21st<\/sup> Annual Global Conference<\/a> in September.<\/p>\n

Completion of clinical trials for regulatory approval is a time-intensive process, but it seems that progress for Sildenafil Cream is moving forward at a steady pace. Stakeholders will continue to watch and wait from the sidelines while Dar\u00e9 moves through the remaining phases for approval with the FDA.<\/p>\n

There are many medication options available via the click of a button for improving sexual health. Visit eDrugstore.com<\/a> to learn about treatments for erectile dysfunction<\/a> and other common issues pertaining to sexual health<\/a>.<\/p>\n

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

\u201cFemale Viagra\u201d may soon come in the form of a topical cream. Dar\u00e9 Bioscience, Inc. and Strategic Science & Technologies, LLC are moving forward\u00a0with presenting their clinical trial plan to the FDA, with hopes of commencing Phase 2b of Sildenafil Cream, 3.6% (Sildenafil Cream) trials by the end of 2019. Sildenafil is the active ingredient […]<\/p>\n","protected":false},"author":13,"featured_media":27675,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_autoblog_aioseo_focus_keyphrase":"","_autoblog_aioseo_title":"","_autoblog_aioseo_description":"","footnotes":""},"categories":[17],"tags":[181,518],"class_list":["post-27674","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-viagra","tag-female-viagra","tag-sildenafil"],"acf":[],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t