“Female Viagra” May Get Approved by FDA This Week Flibanserin, a drug designed to increase libido in women also known as “female Viagra”, could be approved by the U.S. Food and Drug Administration this week. FDA approval of the “female Viagra” would be unprecedented, as no such drug has ever been approved before. WHAT IS FLIBANSERIN? Unlike Viagra, flibanserin aims to raise libido by targeting the female brain's pleasure center instead of the genitals. Proponents of the cite the lack of a female equivalent to Viagra. Unlike men, there is no drug on the market to combat persistent low sexual desire in women, a condition also known as hypoactive sexual disorder (HSDD). But critics of flibanserin say that the negative side effects associated with the drug are too large for it to be released. …show more content…
And aside from these side effects, opponents of the drug say that the cause of HSDD can be psychological, not physical. For these reasons, flibanserin was rejected by the FDA drug safety advisory committee in 2010 and 2013. Despite these concerns, it is likely that flibanserin will receive FDA approval this week. The drug was passed in June (with the condition that the manufacturer take measures to limit safety risks) by the drug safety advisory panel, which it usually follows in approval. As Liz Szabo of USA Today reported, flibanserin manufacturer Sprout Pharmaceuticals has supported a large public relations campaign to get the the pill passed. It appears to be quite successful: 11 members of Congress and the National Organization for Women have written to the FDA in support of the drug. EXPERTS AGAINST THE FEMALE
After a series of successful medicine permitted for the erectile disfunction or the so-referred to as impotence(we could take as an instance Sildenafil, known as "viagra, offered for the reason that 1998 and Vardenafil, also called "Levitra", observed in pharmacies seeing that late August 2003), an extra remedy was created so as to entire the form of those merchandise and allow persons to opt for: this today's remedy is tadafil (its industrial identify is Cialis and could were purchased on account that November 2003).
quest to get a “female arousal” drug approved by the FDA and put out to the market. As Canner
Syntex, Parke Davis and Ortho pharmaceutical firms had introduced their own oral contraceptives to the market, and others were awaiting approval by the Food and Drug Administration. Used by over 6.5 million women, the birth control pill had become the most commonly used form of contraception in the nation.
One of the most significant changes the 21st Century Cures Act would make is altering the FDA's current "breakthrough therapy designation" program, which began in 2012. Under that law, the FDA can speed up the review process of drugs whose early clinical evidence demonstrates particular promise in treating serious or life-threatening diseases. The new bill would additionally allow the agency to grant market approval for drugs that are given the breakthrough designation. Once the drug was on the market, further clinical trials would be required.
Erectile dysfunction’ is the failure to achieve and maintain an erection sufficient for satisfactory sexual experience. It affects 150 million men globally. In March1998, Viagra (Sildenafil) was the first oral medication approved for use in ‘erectile dysfunction. Viagra had a very successful launch with a total of 600,000 prescriptions filled in the first month (April 1998), and instantly became a phenomenon for ED patients. Unfortunately, after six months Viagra suffered a huge setback when the FDA received reports of 130 deaths of patients taking Viagra; over half the incidents were cardiovascular related. Viagra
Often, these side effects are more dangerous than the condition being treated. Yet, this medication are appovered by the FDA. And, this medications are used to treat many Americans without knowing if they are safe for use or not.
he US-FDA, on 18th August, 2015 approved the drug Flibanserin (brand name Addyi) for the treatment of acquired, generalised Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women. Addyi is being dubbed as the "Female viagra" and "the little pink pill".
There are currently none in the marketplace for females. Sprout prescription drugs is the state-of-the-art in a line of corporations hoping to change that. Sprout intends to market its product flibanserin, described as a medication for females with hypoactive sexual desire ailment, beneath the brand title Addyi if the FDA approves it. After two earlier rejections, the drug's possibilities seem brighter this time; an advisory panel previous this month informed the FDA to maneuver ahead with approval. Although the FDA need not follow the panel's recommendation, the company more often than not does
The health issues listed here are just a glance at what this drug can do to one’s health.
In fact, Viagra is a potent drug used by men to increase sexual performance and function. However, most people buy Viagra pills in special stores, not knowing that it can be prepared at home.
Due to these incidents and many severe cases of drug side effects that had happened in the past including deaths, the current way drugs are developed and approved are unethical. Therefore, reform in FDA’s management as well as the guidelines is necessary to strengthen safety standards and eliminate problems regarding drug development and regulation.
Blog Male birth control pill moves a step closer16th August 2012Researchers have finally found a compound that may offer the first effective and hormone-free birth control pill for men.The study, published today in the journal Cell, describes how the small molecule makes male mice reversibly infertile, without putting a damper on their sex drive. When the animals stop taking this new form of birth control, their sperm rebound and they are able to produce perfectly healthy offspring once again."This compound produces a rapid and reversible decrease in sperm count and motility with profound effects on fertility," said James Bradner of the Dana-Farber Cancer Institute and lead author of the study.A male birth control
The pharmaceutical field has overcome countless medical feats since the early times. While “the pill” itself was considered a brand new invention, the idea of creating a birth control pill was not. Since the old times primitive condoms were made from animal intestines and fish bladders. However, it wasn’t until after Margaret Sanger’s multiple convictions and persistent attitude, that a judge ended the Comstock era, providing Sanger with the opportunity to stress the importance of having birth control in th for of a pill to the public.
Carl Djerassi was a chemist in Mexico city that created the first pill that synthesized hormones in 1951. In 1957 the FDA approved the pills for women with menstrual disorders but just three years later the pill was released for sexual protection. Some states still made this drug illegal and it went against many people’s morals. In 1997 the pill was expanded to treat acne (A Brief History 1-2). The pill has come a long way and is still continuing to form in this evolving society. Less than seventy years ago we didn’t even have an oral option for birth control. Today we are fighting over whether the pill can be available over the counter or not.
A quick SWOT analysis shows the new product that would eventually use the PTI technology to have a promising future. The main strength of the product would be the technology with which it is formulated. The resultant product would have much fewer side effects than Viagra if at all and especially be able to cater to population with cardio-vascular disease, which Viagra or other similar products that are based on nitrate therapy, cannot cater to. Thirdly, this new drug had the potential of becoming a cure for the condition instead of a temporary stimulant like all other drugs that are currently in market. The only weakness would be its timing. Although PTI has secured the patent for the technology there is still a long way to go before the final product can be produced. The other important factor is that PTI themselves do not own an important piece of the technology, Factor X which they are hoping to acquire through an alliance with a company owns the technical