from the bundling-agreement-with-pfizer-in-3...2...1..... dept.
On Friday, the Food and Drug Administration approved sales of the peptide bremelanotide (brandname 'Vyleesi'), a shot intended to enhance sexual desire in premenopausal women. Bremelanotide acts as an agonist for the melanocortin receptors which are believed to affect mood and desire.
This should not be confused with the previous poorly received attempt at a 'female viagra' flibanserin (brandname 'Addyi') which required taking a daily pill for up to four weeks to start seeing effects and had warnings about being taken in conjunction with alcohol. The bremelanotide shot does not restrict alcohol use and can be self administered by autoinjector as needed ~45 minutes before anticipated intimacy.
"There are women who, for no known reason, have reduced sexual desire that causes marked distress, and who can benefit from safe and effective pharmacologic treatment," Hylton Joffe, director of the FDA Center for Drug Evaluation and Research's Division of Bone, Reproductive and Urologic Products, said in a statement.
"Today's approval provides women with another treatment option for this condition. As part of the FDA's commitment to protect and advance the health of women, we'll continue to support the development of safe and effective treatments for female sexual dysfunction."
Side effects of the drug are mild and consist primarily of nausea in some women, with even that disappearing after a few doses.
Analysts have estimated potential sales of a drug that "safely and effectively treats loss of sexual desire in women" could amount to sales of about $1 billion annually.
The drug was developed by Palatin Technologies, with AMAG Pharmaceuticals holding exclusive North America sales rights. Both rose sharply Friday on the news.
Additional Coverage here
Flibanserin Related Coverage
Female Libido Pill Approved by FDA, With Caveats
Female Libido Pill Considered by FDA Advisers
Related Stories
A committee of advisers to the U.S. Food and Drug Administration (FDA) are meeting to consider whether the FDA should approve the first drug that aims to boost a woman's libido:
The FDA has twice before rejected the drug, called flibanserin, after previous advisory panels concluded there were questions about its safety and insufficient evidence that the drug was effective for women with low sex drives. Sprout Pharmaceuticals, which makes flibanserin, has submitted more research that the company hopes will finally convince the advisers and the agency the drug is ready for the market. The company's evidence includes a study it says shows women can safely drive after using the medication. One concern about the drug is that it can leave women drowsy the day after taking it, increasing the risks for accidents. "The review of flibanserin... represents a critical milestone for the millions of American women and couples who live with the distress of this life-impacting condition without a single approved medical treatment today," Cindy Whitehead, Sprout's CEO, said in a statement before the hearing began.
Flibanserin, which the company plans to sell under the brand name Addyi if approved, shifts the balance of three key brain chemicals, increasing dopamine and norepinephrine and decreasing serotonin.
The drug has long been the focus of an intense debate. The company and some advocacy groups, including the National Organization for Women and Even the Score, have suggested that the FDA is being sexist by holding the drug to a higher standard than drugs, such as Viagra and Cialis, for male sexual problems. The FDA denies those charges. In documents posted online in advance of the hearing, Hylton Joffe, director of the FDA's Division of Bone, Reproductive and Urologic Products, said that such claims "are misleading and inaccurate." "The FDA rejects claims of gender bias," Joffe wrote. "The FDA's regulatory decision for each product is based on an assessment of whether the benefits outweigh the risks, and does not take gender into consideration." Many women's health advocates agree with the agency's caution and remain opposed to the drug despite the company's new research.
Original Submission
Flibanserin or Addyi, a female libido-enhancing drug created by Sprout Pharmaceuticals, has been approved by a U.S. Food and Drug Administration (FDA) advisory committee:
It was rejected by the FDA twice for lack of effectiveness and side effects like nausea, dizziness and fainting. Women taking the drug reported between half and one more sexually satisfying event per month - results experts admitted were "modest". Originally the drug was produced by German company Boehringer Ingelheim. Sprout bought the drug from that company after it was turned down by the FDA.
Documents from the 4 June FDA advisory meeting describe the drug's purpose of "treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women". Women would take it each night. A doctor would have to determine whether a woman seeking the pill was suffering from a disorder characterised by a lack of sexual fantasies and desire, causing the woman distress. Currently, there is nothing on the US market approved for treatment of HSDD or another condition, female sexual interest/arousal disorder (FSIAD). "This condition is clearly an area of unmet medical need," the FDA documents said.
Reuters adds that the FDA will require a warning over "potentially dangerous low blood pressure and fainting when taken with alcohol."
Previously: Female Libido Pill Considered by FDA Advisers
Original Submission
(Score: 5, Insightful) by PinkyGigglebrain on Sunday June 23 2019, @06:48PM (18 children)
I can already see how this is going to be abused in ways apparently not anticipated by the manufacturer. Though more likely they just don't care about how it will be misused.
As a culture Americans tend to look for drugs to solve problems that are caused by stress, poor diet, and social pressures as opposed to trying to remove the stressors causing the problems in the first place.
"Beware those who would deny you Knowledge, For in their hearts they dream themselves your Master."
(Score: 5, Insightful) by Subsentient on Sunday June 23 2019, @07:00PM
>As a culture Americans tend to look for drugs to solve problems that are caused by stress, poor diet, and social pressures as opposed to trying to remove the stressors causing the problems in the first place.
That tends to happen when it's nearly impossible to remove those stressors. It's much better for there to be an artificial relief than no relief at all.
"It is no measure of health to be well adjusted to a profoundly sick society." -Jiddu Krishnamurti
(Score: 2) by takyon on Sunday June 23 2019, @07:07PM (12 children)
If it's relatively safe, offer it over the counter. If it's not, don't add it to the Drug War.
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(Score: 0) by Anonymous Coward on Sunday June 23 2019, @07:40PM (4 children)
Can we say the same about ED pills? Read the safety warnings about those little beauties ...
(Score: 4, Informative) by Ethanol-fueled on Sunday June 23 2019, @08:06PM (2 children)
I have taken ED medicine, it's no joke. It decreases your hearing ability kinda like when you're flying on a plane at high altitude and everything sounds more quiet, and it causes wicked chest pains occasionally during sex. I was angry at my doctor for cutting off my prescription, as he began to suspect that I was abusing the medication, but looking back he did me a huge favor.
Basically what those medicines do is drop the living fuck out of your blood pressure. So obviously your heart is a big deal, and when you've been drinking and are exerting yourself during sex there's a compound effect since alcohol is already a depressant. I'm pretty sure that I would have literally fucked myself dead had my doctor not cut me off. The "ants-in-your-pants" effects persist for around 24 hours. I never got priapism, though.
(Score: 0, Troll) by Anonymous Coward on Sunday June 23 2019, @09:05PM
EF can't get it up anymore, haa haa!
(Score: 2) by krishnoid on Sunday June 23 2019, @11:03PM
I need to have some words with that man. "He was kind of a jerk on the interwebs, but you can't beat going out the way he did." :-)
(Score: -1, Redundant) by Anonymous Coward on Sunday June 23 2019, @08:22PM
but you don't understand
we have to offer a rape pill free of charge because it's no danger to men
the only thing incels fear is women's independent sexuality
(Score: -1, Troll) by Anonymous Coward on Sunday June 23 2019, @08:14PM (1 child)
but date rape
only an incel worries about personal liberties when the rapeocalypse is imminent
i'm surprised that the legal weed has lasted as long as it has without being date raped, because if womanhood is anything but suffering, worst of all sexual, then feminists get all triggered
(Score: 2) by takyon on Sunday June 23 2019, @09:09PM
It's not on anybody's radar and probably won't be for years.
http://www.takepart.com/article/2014/08/25/pot-date-rape-drug/ [takepart.com]
http://adai.uw.edu/pubs/pdf/2017mj_sexualassault.pdf [uw.edu]
It's on the same level as alcohol as a date rape drug. With alcohol you could spike drinks with vodka to raise the ABV, and with weed you could make absolutely loaded edibles and get the victim to ingest them.
[SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
(Score: 4, Insightful) by PinkyGigglebrain on Sunday June 23 2019, @09:05PM (4 children)
I guess not everyone's mind can see how this will be abused. That is actually a good thing.
When people hear "stimulates a woman's libido" what they think is "Its an aphrodisiac". What I know is going to be a problem is guys who put this stuff in their girlfriend's or date's drink thinking it will improve their chances of getting laid. I just know we are going to start hearing about women being given this drug without their knowledge or consent. That is what I was commenting on.
"Beware those who would deny you Knowledge, For in their hearts they dream themselves your Master."
(Score: 3, Insightful) by takyon on Sunday June 23 2019, @09:12PM (1 child)
Not everyone's mind cares about how it can be abused. We care about the larger abuses perpetrated by government.
Bremelanotide is used as an injection, so you'd have to get pretty creative with that one.
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(Score: 1, Funny) by Anonymous Coward on Monday June 24 2019, @12:50AM
Only target diabetics?
(Score: 3, Interesting) by krishnoid on Sunday June 23 2019, @11:05PM (1 child)
Considering the potential for abuse (even if it doesn't work that way), it would help if the standard formulation could be one that breaks apart or otherwise loses its properties in alcohol solution.
(Score: 3, Insightful) by JNCF on Monday June 24 2019, @04:38PM
Sounds like it's an injection. Alcohol can be injected, but if your date offers a hypodermic needle of alcohol to get the night going I'd expect it to raise some red flags for other reasons.
(Score: 3, Funny) by PinkyGigglebrain on Sunday June 23 2019, @09:13PM (2 children)
My first "Flamebait" modding ever!!!
Been posting for years on the Internet and this is a first!
Time to break out the champagne!
"Beware those who would deny you Knowledge, For in their hearts they dream themselves your Master."
(Score: 2) by RS3 on Sunday June 23 2019, @09:28PM (1 child)
Oh, sorry, I ruined it before I saw this post. Hate to ruin a champagne moment. I thought you made a good point and I don't understand who down-mods things like that. Reminds me of youtube trolls- thumbs-downing a great vid. I'll mod you "flamebait" next time if you like. It won't cost me a cent. :)
(Score: 3, Funny) by PartTimeZombie on Sunday June 23 2019, @10:52PM
Wait, are you guys not paying for those Flamebait mods?
Hey, Runaway, I want my $2.25 back!
(Score: 1) by khallow on Monday June 24 2019, @02:18AM
How does that differ from any other culture. All cultures have people who don't deal with stress in the way you expect.
(Score: 5, Interesting) by esperto123 on Sunday June 23 2019, @07:54PM (6 children)
There is a big fail on articles about this subject, people always call these medicines "female viagra" but they are completely different. The male problem that viagra target is with erection, the man has the desire but cannot "get it up", the equivalent to that on a woman is vaginal dryness. These drugs target the desire, that, for all sorts of reasons, diminishes in women, specially as they get older. There is a good chemical to solve that, it is called testosterone, it would make most women dry hump random people at the subway, but has a lot of side effects like body hair growth, voice pitch change and others (i'm considering the dry humping a good side effect hahahha)
(Score: 4, Informative) by Ethanol-fueled on Sunday June 23 2019, @08:08PM (4 children)
It's widely understood that drugs like Viagra work similarly with women, and I have firsthand experience in the matter. I don't know why the objective for female Viagra was to target the mood, because plain stock Viagra gets the ladies hot and juicy just fine.
(Score: 4, Funny) by Anonymous Coward on Sunday June 23 2019, @09:31PM (3 children)
That line, being posted by EF, makes me want to vomit, then join a monastery.
(Score: 2, Funny) by Anonymous Coward on Sunday June 23 2019, @09:39PM (2 children)
Don't worry, those ladies have dicks.
(Score: 0) by Anonymous Coward on Monday June 24 2019, @01:33AM (1 child)
That might be slightly worse.
(Score: 3, Informative) by Subsentient on Monday June 24 2019, @03:40AM
Or significantly better.
"It is no measure of health to be well adjusted to a profoundly sick society." -Jiddu Krishnamurti
(Score: 0) by Anonymous Coward on Monday June 24 2019, @06:00AM
I think the reason is because pills to treat ED aren't so much seen as being "ED pills," but rather as "anti-frustration" pills. Underlying this is that most men have higher testosterone and, therefore, higher libido, which means that their frustration comes from the fact that their equipment malfunctions. For most women with frustration, according to the research, they have functioning equipment (or cope using supplementary lubricant or other techniques) and want sex on a mental level, but the problem is flipping the switch from wanting it as a mental concept to being in the mood or ignoring anaphrodisiac thoughts once in the mood.
(Score: 3, Insightful) by krishnoid on Sunday June 23 2019, @11:13PM (1 child)
I don't really mind ads that much, but I've never been so grateful that SoylentNews doesn't hook into any of the ad networks, as when I clicked to read more details on this particular article. Thank you thank you thank you, you'll probably be seeing some more of my money soon.
(Score: 2) by takyon on Monday June 24 2019, @01:12AM
Is there any more relevant ad than v1aGagagagarrara?
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(Score: 3, Insightful) by Alfred on Monday June 24 2019, @01:24PM (4 children)
(Score: 2) by JNCF on Monday June 24 2019, @05:30PM
Have you ever drank coffee to help you focus on a problem your mind was slipping away from? Coffee doesn't have this effect for everyone, but personally I find the general case of taking a drug to engage in an activity I have cognitive dissonance about to be highly relatable.
(Score: 2) by Snow on Monday June 24 2019, @05:32PM (2 children)
Because sometimes you want to do something you don't want to do.
ie. You want to want it.
(Score: 2) by Mykl on Tuesday June 25 2019, @01:07AM (1 child)
I would pay money for drugs that could make me want to:
(Score: 4, Funny) by Snow on Tuesday June 25 2019, @02:14AM
- Adderall
- Meth
- Adderall
- Butter
(Score: 2) by OrugTor on Monday June 24 2019, @01:39PM
When I was a lad they were known as "English girls".
(Score: 0) by Anonymous Coward on Monday June 24 2019, @02:54PM
Leave the old ballsack and find a younger man. That's what works the best.
(Score: 0) by Anonymous Coward on Monday June 24 2019, @06:35PM (1 child)
i can see it now. a chemical "therapy" that makes women infertile and horny as hell, put into the water supplies. no more crime. men all tuckered out, poor things.
(Score: 0) by Anonymous Coward on Tuesday June 25 2019, @12:12PM
It's called a college degree.