Lybrido tablet

Previous attempts to develop a drug treatment for HSDD have fallen into the “one-size-fits-all” approach, while failing to acknowledge the complexity of female sexuality. Freya’s solutions are based on known neurobiological mechanisms that are important in sexual excitation and inhibition in women. Lybrido focuses on treatment for patients with HSDD, in which low sexual desire results from a central nervous system that is relatively insensitive to sexual cues. In these individuals, exposure to sexual stimuli (internal or external) fails to trigger activation of the brain’s sexual excitatory mechanisms 1-4. Lybrido has been developed for patients with HSDD, who are relatively insensitive to sexual cues. It increases central sexual motivation and physiological sexual responses, such as swelling of vaginal erectile tissue and lubrication. Lybrido contains sildenafil (a phosphodiesterase type 5 inhibitor) with a time-release coating and an outer testosterone shell. A Phase 3 trial for Lybrido is currently in preparation, and is expected to run from late 2022 until mid-2024. Three phase 2 studies (two for Lybridos and one for Lybrido) have been conducted at 16 research sites in the United States. The efficacy and safety of various doses of testosterone, sildenafil, buspirone and combination therapies (testosterone + sildenafil, testosterone + buspirone) were tested in 497 women with HSDD to determine the change in satisfying sexual events (SSEs) over a period of eight weeks. In...

AMSTERDAM, Feb. 22, 2023 /PRNewswire/ -- 18 February, 2023, in Rotterdam, The Netherlands, showed great interest in Freya's innovative drug candidate Lybrido TM. The ESSM congress was attended by around 700 participantsfrom 59 countries around the worldrepresenting a broad range of sexual health practitioners. The designfor the confirmatory ALETTA clinical trialwas presented by Professor Cobi Reisman, member of Freya's Scientific Advisory Board and urologist, sexologist, lecturer, honorary professor, and currently medical director of Flare-Health institute in Amstelveen, the Netherlands. Furthermore,during a very well attended round table discussion entitled "Hypoactive Sexual Desire in young women: What women want"conversationstook place among key experts in the field.Professor Linda Vignozzi, Professor Annamaria Giraldi, Dr. Shelly Varod, Dr. Giovani Corona,and Professor Cobi Reisman referred to Lybrido TMas a promising innovative treatment for women suffering from FSD.From the many questions and discussions that followed theexperts' presentations, it can be concluded that there is a highunmet need among women suffering from FSD for effective and safe treatments, which are currently not available in Europe, and that Lybrido TMis expected to address such a need. Dr. Jan van der Mooren, Chief Medical Officer at Freya Pharma Solutions said: "I wasdelighted to experience such positive feedback on Lybrido TM from so many sexual health experts and practitioners. Even though we...

AMSTERDAM, May 9, 2023 /PRNewswire/ -- the United States (US) Food and Drug Administration (FDA) has informed Freya that they will provide a written response by 4 June on the request for advice on the US Clinical Development Program of Lybrido â„¢for the treatment of Female Sexual Interest/Arousal Disorder (FSIAD). Freya_Pharma_Solutions_Logo After obtaining advice from the European Medicines Agency (EMA) in September 2022, Freya Pharma Solutions is currently preparing the confirmatory ALETTA trial as part of the clinical development program of Lybrido â„¢in Europe. As a next step Freya has designed a clinical development program for the US in close collaboration with its Scientific Advisory Board consisting of leading experts in the field of FSD from the US and Europe, to prepare for a Marketing Authorization Application(MAA)of Lybrido â„¢in the US. On Freya's request for advice, theFDA has now planned toprovide a written response by 4 June 2023, where Freya's objective is to reach an agreement with the agency regarding the clinical development program of Lybrido â„¢in the US. Dr. Jan van der Mooren, Chief Medical Officer at Freya Pharma Solutions said: " The announced response from the FDA on our clinical development p rogram for Lybridoâ„¢ in the US marks a major next step in our plans to bring Lybrido â„¢ to the market , a nd to make a contribution to the lives of many women suffering from FSD. I t can be concluded that there is a high unmet need among women suffering ...

Move over zombies. There’s a new monster coming to town: the sex-crazed, aggressive woman. Left unstopped, these raging nymphomaniacs will facilitate a chaotic world in which women not only desire and enjoy sex, but seek it with uncontrollable doggedness. So say skeptics of Lybrido, the female Viagra equivalent expected to become available in 2016. Before Lybrido was approved for eventual release, predominantly male industry advisers expected that companies would reject the drugs for fear that they would trigger “female excesses, crazed binges of infidelity [and] societal splintering,” wrote New York Times journalist Daniel Bergner in May 2013. Critics of the nymphomania-fearing skeptics consider this stance offensive paranoia. Some wonder whether a need for such medication even exists. How Does It Really Work? Lybrido and its sister drug Lybridos were designed to treat hypoactive sexual desire disorder—a condition that causes low sex drive in 10 percent of women, according to the International Society for Sexual Medicine. Lybrido was created to increase sensitivity to sexual cues, such as kissing and caressing, in women who are lacking. Lybridos aims to reduce a woman’s overactive “sexual brake,” which can halt physical arousal even when she’s emotionally turned on. Both drugs contain testosterone, which is where notions of sex-crazed pugnacity derive, said Jos Bloemers, MSc, the director of scientific operations at Emotional Brain B.V. in the Netherlands, where the drugs...

John Sterling Editor in Chief Genetic Engineering & Biotechnology News Last month on May 22 the NY Times ran an article in its Sunday magazine about a new pill being developed to increase women’s sex drive. Combining testosterone and a drug similar to Viagra, the pill, named Lybrido, demonstrated “very impressive” results in a recent clinical trial, according to its developer, Netherlands-based Emotional Brain, and could hit the market in three years. Despite the long-prevailing view that it is men who are more likely to bore of a current female sexual partner, turns out, according to the Times, that it is the XXers who are the first to consider bailing out of the love boat, usually within one to four years after the beginning of a relationship with a man. Excruciating boredom with monogamy seems to be a lust killer. Whether a pill will ultimately be the answer for this sense of sexual monotony remains to be seen, despite the drug manufacturer’s claim to the contrary. For most people, sex comes with an acquired set of cultural beliefs and emotional expectations, maybe more often the case for women than men. I’m not sure a pill is the “cure” here. News reports indicate that women still handle most of the home-related tasks, including cooking, cleaning, and taking care of the kids. More women are doing so in single-parent households, and a Pew Research Center study just reported that working mothers now serve as the sole breadwinners for 40% of all U.S. families. Seems to me...

Amsterdam, the Netherlands, 29 June 2022 – Dr. Jan van der Mooren, Chief Medical Officer of Freya, stated: “This application for EMA scientific advice is a major step in Freya’s development program for Lybrido, which is offering an effective and safe treatment for women suffering from FSIAD. Lybrido will be an innovative drug in a market with very few approved drugs in the United States, and no drug being approved in Europe so far.” With great support of the members of the Scientific Advisory Board, Freya has drafted a thorough and detailed clinical study protocol of a randomized placebo-controlled phase 3 clinical trial to demonstrate the efficacy and safety of Lybrido. Clinical research organization CR2O BV (www.CR2O.nl) is leading the preparation, execution and reporting of this trial. The trial has been given the short name “ALETTA”, referring to Aletta Henriëtte Jacobs, a Dutch physician and women’s suffrage activist. As the first woman to officially attend a Dutch university, she became one of the first female physicians in the Netherlands. Freya Pharma Solutions is currently preparing the first phase 3 clinical trial in Europe as part of a clinical development program with several studies in Europe, and later also in the United States. The company is highly confident that it is well on track with establishing Lybrido as a treatment for women suffering from sexual dysfunction, and the related distress which often negatively interferes with their quality of life. Abou...

A flibanserin tablet sits on a brochure for Sprout Pharmaceuticals in the company's Raleigh, N.C., headquarters. Company officials on Dec. 11 announced that it had reached an impasse with the Food and Drug Administration over flibanserin, a pill designed to be taken daily to increase libido in women by acting on brain chemicals linked to mood and appetite. “There are a lot of people who want a drug for women who feel like there is something basically unfair,” he said. “Nobody is against the development of a drug for women. But you either accept the [scientific] standards set and interpreted by the FDA, ensuring clear [effectiveness and safety] of a compound, or you don’t.” Lorexys: A non-hormonal combination, in pill form, of two antidepressants (bupropion and trazodone), the drug is in Phase 2 trials for premenopausal women with HSDD. Studies are expected to last for three years. The Center for Marital and Sexual Health, one of two sites in the U.S., is still recruiting for that trial. “It’s unlikely that any testosterone [therapy] will be able to get FDA approval for women,” Kingsberg said. Twenty percent of all testosterone prescriptions are those that are written off-label (for something other than its intended use) for women, she said, an indication of the demand. Off-label prescriptions usually aren’t covered by health insurance, though, and the formulations don’t work for all women. Bremelanotide: Clinical trials have shown that the drug, a liquid injected just unde...

Amsterdam, the Netherlands, 25 August 2022 – Last year Freya Pharma Solutions acquired all Intellectual Property (IP) for two innovative drugs, Lybrido and Lybridos, developed for the treatment of women suffering from FSIAD. With the new patent applications announced today, Freya will significantly strengthen its IP position in this area, and add strong additional protection until 2042, thereby extending its value life cycle. Upcoming pivotal phase 3 trial Freya Pharma Solutions plans to conduct a pivotal phase 3 clinical trial to confirm the efficacy and safety of Lybrido in women suffering from FSIAD. In June this year, a clinical trial application was submitted to the European Medicines Agency (EMA) for scientific advice on the upcoming phase 3 clinical trial with Lybrido for the treatment of FSIAD. The trial will be conducted within the European Union in accordance with Good Clinical Practices and the ethical principles stated in the Declaration of Helsinki. It will comply with the EU Clinical Trial Regulation (No. 536/2014), all other applicable laws and regulations, as well as requirements of applicable Member States where the study is undertaken. Dr. Jan van der Mooren, Chief Medical Officer of Freya, stated: “Lybrido is a unique therapeutic concept, both in its combination of testosterone and sildenafil, as well as in its dual route, dual release, fixed dose system, thereby achieving the optimal synergy of both active ingredients. Lybrido will be an innovative drug...