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ExcelFemale
HRT in Women
FDA Panel Backs Fibanserin, the First Female Libido Drug
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<blockquote data-quote="Nelson Vergel" data-source="post: 19839" data-attributes="member: 3"><p>This is a peptide that some men have used on this site. Palatin Technologies is studying it for improving female libido to compete with Fibanserin.</p><p></p><p></p><p>"<strong>Bremelanotide for Female Sexual Dysfunction</strong></p><p></p><p><strong>Palatin Technologies is developing bremelanotide for female sexual dysfunction, or FSD. Bremelanotide is in Phase 3 clinical trials; to find out more about Palatin's current bremelanotide trials or if the studies are enrolling patients in your area, please visit <a href="http://www.clinicaltrials.gov/" target="_blank">www.clinicaltrials.gov</a>,<a href="http://www.reconnectstudy.com/" target="_blank">www.reconnectstudy.com</a> or email <a href="mailto:reconnectstudy@palatin.com">reconnectstudy@palatin.com</a>.</strong></p><p></p><p>We are developing subcutaneously administered bremelanotide for the treatment of FSD in premenopausal women. Bremelanotide, which is a melanocortin agonist, is a synthetic peptide analog of the naturally occurring hormone alpha-MSH. The novel mechanism of action involves activating endogenous melanocortin hormone pathways involved in sexual arousal response.</p><p>We have completed a Phase 2B clinical trial and meetings with the U.S. Food and Drug Administration (FDA), and started patient enrollment in the Phase 3 clinical trials in December 2014. The Phase 3 studies, which will be conducted in North America, will utilize a single-dose autoinjector intended for commercialization. It is anticipated that the Phase 3 program will take at least fifteen to eighteen months from initiation of patient dosing through database lock. Following database lock, clinical trial data will be analyzed and, assuming the data supports approval of bremelanotide for FSD, a New Drug Application (NDA) will be submitted to FDA."</p><p></p><p><a href="http://www.palatin.com/products/bremelanotide.asp" target="_blank">http://www.palatin.com/products/bremelanotide.asp</a></p></blockquote><p></p>
[QUOTE="Nelson Vergel, post: 19839, member: 3"] This is a peptide that some men have used on this site. Palatin Technologies is studying it for improving female libido to compete with Fibanserin. "[B]Bremelanotide for Female Sexual Dysfunction[/B] [B]Palatin Technologies is developing bremelanotide for female sexual dysfunction, or FSD. Bremelanotide is in Phase 3 clinical trials; to find out more about Palatin's current bremelanotide trials or if the studies are enrolling patients in your area, please visit [URL="http://www.clinicaltrials.gov/"]www.clinicaltrials.gov[/URL],[URL="http://www.reconnectstudy.com/"]www.reconnectstudy.com[/URL] or email [EMAIL="reconnectstudy@palatin.com"]reconnectstudy@palatin.com[/EMAIL].[/B] We are developing subcutaneously administered bremelanotide for the treatment of FSD in premenopausal women. Bremelanotide, which is a melanocortin agonist, is a synthetic peptide analog of the naturally occurring hormone alpha-MSH. The novel mechanism of action involves activating endogenous melanocortin hormone pathways involved in sexual arousal response. We have completed a Phase 2B clinical trial and meetings with the U.S. Food and Drug Administration (FDA), and started patient enrollment in the Phase 3 clinical trials in December 2014. The Phase 3 studies, which will be conducted in North America, will utilize a single-dose autoinjector intended for commercialization. It is anticipated that the Phase 3 program will take at least fifteen to eighteen months from initiation of patient dosing through database lock. Following database lock, clinical trial data will be analyzed and, assuming the data supports approval of bremelanotide for FSD, a New Drug Application (NDA) will be submitted to FDA." [URL]http://www.palatin.com/products/bremelanotide.asp[/URL] [/QUOTE]
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ExcelFemale
HRT in Women
FDA Panel Backs Fibanserin, the First Female Libido Drug
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