AMSTERDAM, Aug. 25, 2022 /PRNewswire/ — Freya Pharma Solutions, a late scientific stage pharmaceutical firm specializing in the event of efficient pharmaceutical therapies for girls identified with Female Sexual Interest/Arousal Disorder (FSIAD), at this time introduced the submitting of latest patent purposes for improved remedy of FSIAD.
Last yr Freya, Pharma Solutions acquired all Intellectual Property (IP) on 2 progressive medicine, Lybrido and Lybridos, developed for the remedy of girls affected by FSIAD. With the brand new patent purposes introduced at this time, Freya will considerably strengthen its IP place on this space, and add robust extra safety up till 2042, thereby extending its worth life cycle.
Upcoming pivotal section 3 trial
Freya Pharma Solutions plans to conduct a pivotal section 3 scientific trial to substantiate the efficacy and security of Lybrido in girls affected by FSIAD. In June this yr a scientific trial software was submitted to the European Medicines Agency (EMA) for scientific recommendation on the upcoming pivotal section 3 scientific trial with Lybrido for the remedy of FSIAD. The section 3 scientific trial can be performed throughout the European Union in accordance with Good Clinical Practices and the moral rules acknowledged within the Declaration of Helsinki. It will adjust to the EU Clinical Trial Regulation (No. 536/2014), all different relevant legal guidelines and rules, in addition to necessities of relevant Member States the place the examine is undertaken.
Dr. Jan van der Mooren, Chief Medical Officer of Freya, acknowledged:
“Lybrido is a novel therapeutic idea, each by its mixture of testosterone and sildenafil, in addition to by its twin route, twin launch, fastened dose system, and as such reaching the optimum synergy of each energetic substances. Lybrido can be an progressive drug in a market with only a few permitted medicine within the United States, and no drug being permitted in Europe thus far. With the brand new patent purposes Freya will additional strengthen its IP place and supply robust safety for efficient and secure remedy for girls affected by FSIAD.”
Low sexual want is constantly reported as the most typical sexual criticism in girls. As a end result, many ladies are dissatisfied with their intercourse lives, which frequently impacts their social and emotional wellbeing. FSIAD is a sexual dysfunction that’s outlined within the 2013 model of the DSM-5 Diagnostic and Statistical Manual of Mental Disorders, a publication by the American Psychiatric Association, as a persistent lack or vital discount of sexual curiosity and/or arousal. Persons might be medically identified after having a well-defined variety of signs inflicting clinically vital misery and which have persevered for no less than six months. The dysfunction is specified by severity stage and subtyped into lifelong versus acquired, generalized versus situational.
A complete of 20 section 1 and section 2a trials and large-scale section 2b trials in 17 analysis websites within the US have been performed thus far. These trials have investigated the efficacy and security of two novel on-demand pharmacological remedies which have been designed to deal with two FSIAD subgroups: girls with low sensitivity for sexual cues (Lybrido) and girls with over-activation of sexual inhibition (Lybridos). Lybrido will increase central sexual motivation and physiological sexual responses, comparable to swelling of vaginal erectile tissue and lubrication. The remedy might be taken ‘on demand’ and helps to extend central sexual motivation from 3 to six hours after consumption. This remedy consists of a novel (dual-route, dual-release, fixed-dose) mixture pill consisting of a testosterone coating for sublingual administration and an inner-core element containing the phosphodiesterase kind 5 (PDE 5) inhibitor, sildenafil. The inner-core element is coated with a delayed-release matrix to make sure that the height plasma focus of the sildenafil coincides with the window of elevated sexual motivation induced by the testosterone element. Thus, this mix permits a rise in genital arousal by a rise in responsivity to sexual stimuli.
About Freya Pharma Solutions
Freya Pharma Solutions is a late scientific stage firm centered on growing efficient pharmaceutical therapies for FSIAD, constructing upon fifteen years of strong analysis. The firm has two compounds in growth, Lybrido and Lybridos, to handle the vary of potential causes of FSIAD. Based in Amsterdam, The Netherlands, Freya goals to supply sufferers a handy, customized ‘on demand’ answer for this acknowledged unmet medical want.
Please contact for additional info:
Freya Pharma Solutions, Amsterdam
Marcel Wijma, Executive Director
LifeSpring Life Sciences Communication, Amsterdam
T: +31 6 538 16 427
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SOURCE Freya Pharma Solutions
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