terça-feira, 18 de outubro de 2016

Flibanserin – Addyi’s FDA Approved Female Viagra Equivalent?

There are thousands of pharmaceutical solutions available on the market today that are designed to enhance libido and sexual satisfaction in men, including medications such as viagra and cialis and hundreds of different chemical and herbal supplements. Absent from this lengthy roster of libido boosters, however, is a solution designed specifically for women. Recent statistics published in scholarly articles demonstrate that between 4% and 7% of the female population suffer from sexual dysfunction, a percentage far more prevalent than the 1%-5% of men.

Until now, there has been no pharmaceutical solution that delivers effective relief from this issue. Defined by low sexual desire, difficulties in achieving sexual arousal and other persistent and recurring issues that interfere with and impede sexually satisfying events, female sexual dysfunction issues are infrequently addressed by the huge pharmaceutical industry. Sprout Pharmaceuticals, a division of North American pharmaceutical giant Valeant Pharmaceuticals, however, has recently released a new medication that offers a solution to this widespread problem.

What Is Flibanserin?

Called Flibanserin and sold under the brand name Addyi, this relatively new medication has had a complex and troubled history since it’s original release in 2010. Originally formulated as an antidepressant, Flibanserin demonstrated properties that assist premenopausal women with hypoactive sexual desire disorder, or HSDD. The FDA expert panel in charge of approving new pharmaceutical solutions has rejected the drug twice in the last five years, citing dangerous side effects such as dizziness, sleepiness, and nausea.

In the last five years, a number of advocacy groups spearheaded by a women’s health group called Even The Score, has actively campaigned for the approval of Flibanserin, gaining letters of support from notable organisations such as the National Organization for Women and the Journal of Sexual Medicine, as well as several members of US Congress.

The advocacy has had a large impact on the legalization of this revolutionary pharmaceutical, and in July 2015 the FDA approved the sale and distribution of Flibanserin with a caveat that Sprout Pharmaceuticals creates a plan of action to address the safety concerns of this new medical solution.

How Does Flibanserin Differ From Male Specific Pharmaceuticals?

Typical medication solutions formulated to act upon the male body to solve common sexual issues such as erectile disfunction such as Cialis or Viagra work through a mechanism of action that targets the cardiovascular system. These solutions enhance the amount of blood flow to the penis which allows users to more easily achieve and sustain erections, which comes with a small risk of cardiovascular complications but is safe in controlled amounts.

As the mechanism of sexual function in women is vastly different in women than in men, Flibanserin is targeted to affect primarily neurological systems as opposed to the cardiovascular system. Flibanserin is classified as an agonist, or a chemical that binds to a receptor in the brain to provide a biological response.

By acting as an agonist and binding to specific receptors in the brain, Flibanserin is able to modulate levels to two specific chemical compounds that control the neurological process of sexual arousal in women. Dopamine and Norepinephrine levels are increased by the Flibanserin formulation, while serotonin levels are decreased, causing an effective and immediate increase in sexual arousal.

How Effective is Flibanserin?

There have been several scientific clinical trials that demonstrate the effectiveness in Flibanserin in providing relief from the effects of HSDD. In one notable trial, participants experiencing HSDD that were dosed with Flibanserin experienced and increase in “sexually satisfying events” by between 2.8 and 4.5 times a month, a significant amount higher than the placebo control group.

Three separate clinical trials have demonstrated the effectiveness in Flibanserin in relieving HSDD, with each trial concluding that the pharmaceutical provided both in increase in sexually satisfying events and a decrease in distress caused by sexual dysfunction.

The side effects caused Flibanserin have been the primary cause of concern for the FDA experts that approved the use of the drug. In clinical trials the majority of side effects ranged from mild to moderate, with the most commonly reported unwanted symptoms including nausea, dizziness, sleepiness, fatigue and difficulties maintaining a regular sleep schedule.

FDA Approval and Limitations

The new FDA approval of Flibanserin comes in response to extensive research conducted by Sprout Pharmaceuticals that provide a better understanding of the mechanisms of action of the drug and its potential side effects. In 2013 Sprout submitted a comprehensive response to the original rejection, including a wide range of data gathered from Phase 3 trials and a number of Phase 1 drug-drug interaction studies to measure the effects of Flibanserin when used in combination with other pharmaceutical solutions.

A vote performed by the US FDA Advisory Committee on the 4th of June, 2015 recommended approval with an 18-6 result in favor of Flibanserin. A caveat, however, on the release of the drug was that Sprout Pharmaceuticals provide comprehensive and detailed information to both prescribing medical professionals and patients prescribed the drug on the potential hazards and side effects of Flibanserin. Flibanserin will be prescribed and supplied with information on interactions with other pharmaceutical solutions and is not able to be taken with alcohol, due to a severe drop in blood pressure resulting in the interaction between the two. Viagra, the male equivalent, is similarly incompatible with alcohol.

Upon initial release, Flibanserin had a slow response from the American public, with just 227 prescriptions in the first week from release. There are several factors that delayed the initial market penetration, such as a small online course that must be performed by physicians before they can prescribe Flibanserin to ensure they are educated about the potential side effects, and the potential interactions with alcohol.

As of February 2016 there have been thousands of prescriptions of Flibanserin across the United States, with many users experiencing a vast improvement in their sexual lives. Prescribed primarily to premenopausal women that experience HSDD, for many Flibanserin is a relationship saving and life changing drug, and the first step towards equality in sexual pharmaceuticals.



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