News FDA Approves Libido Pill for Women

Discussion in 'The Howard Stern Show' started by Miss America, Aug 20, 2015.

  1. Miss America

    Miss America Well-Known Member

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    Did a Dawg Shed member write this NY Times article? It's hilarious.

    1. Dr. Janet Woodcock, a senior F.D.A. official--She said Wood, huh, huh, huh.
    2. Cindy Whitehead, the chief executive of Sprout. Sounds prejudiced to me. . . .
    3. Advocates who pressed for approval of Addyi, many of them part of a coalition called Even the Score. Founding member?
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    4. “For us to fold up our tent would be premature.”--Really--women are going to pitch a tent now?
    5. Drug is called Addyi--- Wood-yi would have been a better name.

    "Disturbing how this pill got approved. In one trial, for instance, women who took the drug had an average of 4.4 “satisfying sexual experiences” a month, compared with 3.7 for women getting a placebo and 2.7 before the study began."

    Really? 0.7 additional satisfying experiences per month? This warrants FDA approval? Isn't 0.7 the number of annual satisfying sexual experiences this person has per year?
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    Seems the approval was driven by the Even the Score movement--some sort of equality-based organization.

    Finally--can't drink alcohol with Addyi? Wouldn't it be easier and cheaper to get drunk and fuck?
    ------------------------
    http://www.nytimes.com/2015/08/19/business/fda-approval-addyi-female-viagra.html?_r=0

    F.D.A. Approves Addyi, a Libido Pill for Women
    By ANDREW POLLACKAUG. 18, 2015
    The first prescription drug to enhance women’s sexual drive won regulatory approval on Tuesday, clinching a victory for a lobbying campaign that had accused the Food and Drug Administration of gender bias for ignoring the sexual needs of women.

    The drug — Addyi from Sprout Pharmaceuticals — is actually the first drug approved to treat a flagging or absent libido for either sex. Viagra and other drugs available for men are approved to help achieve erections, or to treat certain deficiencies of the hormone testosterone, not to increase desire.

    Advocates who pressed for approval of Addyi, many of them part of a coalition called Even the Score, said that a drug to improve women’s sex lives was long overdue, given the many options available to men.

    But critics said the campaign behind Addyi had made a mockery of the system that regulates pharmaceuticals and had co-opted the women’s movement to pressure the F.D.A. into approving a drug that was at best minimally effective and could cause side effects like low blood pressure, fainting, nausea, dizziness and sleepiness.

    In announcing the approval, Dr. Janet Woodcock, a senior F.D.A. official, said the agency was “committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

    The F.D.A. decision on Tuesday was not a surprise since an advisory committee of outside experts had recommended by a vote of 18 to 6 in June that the drug be approved, albeit with precautions required to try to limit the risks and ensure that it was not overused.

    Addyi’s label has a boxed warning — the strongest kind — saying the drug should not be used by those who drink alcohol, since that can increase the risk of severely low blood pressure and fainting. It is also not to be used with certain other drugs and by people with liver impairment.

    The pill can be prescribed or dispensed only by doctors and pharmacists who watch an online slide presentation and pass a test of their comprehension. Women are advised to stop using the drug if they see no effect after eight weeks.

    The big question now is how many people will use Addyi (pronounced ADD-ee), which is also known as flibanserin and has been called the “pink Viagra.”

    According to one survey, about 10 percent of women suffer from hypoactive sexual desire disorder. The F.D.A. said the drug was approved for women whose loss of sexual desire causes marked distress or interpersonal difficulty and is not the result of illness, relationship problems or side effects of other medicines.

    Cindy Whitehead, the chief executive of Sprout, declined to predict sales of Addyi, which she said would be available starting Oct. 17.

    To allay concerns that the drug would be overused, Sprout has said it would not advertise on radio or television for 18 months after the drug’s approval. Ms. Whitehead said the company would focus its marketing on doctors, not consumers. She said Sprout planned to hire 200 sales representatives, enough to call on about 30,000 doctors, mainly obstetricians and gynecologists but also some psychiatrists and primary care physicians.

    Ms. Whitehead said that she expected many would, with a co-payment of about $30 to $75 a month. Sprout will assist patients with co-payments, she said.

    Some doctors might use the drug beyond the uses in the label, which doctors are allowed to do.

    Dr. Streicher said that although the drug was approved for premenopausal women only, she “absolutely” would prescribe it for postmenopausal women as well.

    Dr. Irwin Goldstein, a sex-medicine doctor in San Diego who has been a consultant to Sprout, said he would not necessarily withhold the drug from casual drinkers. Some women might find the risk of side effects acceptable if their relationships are in jeopardy because of a lack of desire, he said. “That’s a risk, too.”

    Dr. Goldstein said he would also not rule out prescribing the drug off-label to men.

    Ms. Whitehead said there was interest in learning whether the drug would work for men, but Sprout’s priorities would be to get it approved next for postmenopausal women and in foreign markets.

    Continue reading the main story
    Addyi is thought to work by changing the balance of certain brain neurotransmitters like dopamine and serotonin.

    There are disagreements among researchers as to what constitutes normal sexual desire in women. And there have been difficulties bringing to market a drug that would treat low desire.

    Procter & Gamble failed to win approval for a testosterone skin patch for women about a decade ago. The F.D.A. rejected Addyi twice, in 2010 and 2013, citing marginal effectiveness and the side effects.

    In one trial, for instance, women who took the drug had an average of 4.4 “satisfying sexual experiences” a month, compared with 3.7 for women getting a placebo and 2.7 before the study began. The drug did not increase desire more than a placebo when measured by a daily diary, but did do so modestly when measured by a monthly questionnaire.

    After the first rejection, Boehringer Ingelheim abandoned the drug. Ms. Whitehead and her husband, Robert, were at the time running a company that sold a testosterone product for men. The Whiteheads sold that business and formed Sprout to acquire flibanserin. Based in Raleigh, N.C., Sprout, a privately held company, had raised about $100 million, Ms. Whitehead said.

    After the second rejection, various women’s and health groups formed Even the Score.

    Sprout is paying at least part of the expenses for the coalition, whose members include the National Council of Women’s Organizations, the Black Women’s Health Imperative and the Association of Reproductive Health Professionals.

    Even after the favorable advisory committee vote, critics of the drug sent letters to the F.D.A. urging it to reject Addyi. The agency usually follows the advice of its committees, but does not have to.


    “It’s never been about one treatment,” said Ms. Greenberg of the National Consumers League, which received a contribution from Sprout and which formally joined Even the Score this month.

    For us to fold up our tent would be premature.”
     
    IfTheyOnlyKnew likes this.
  2. queerface

    queerface Un-engaged Dyke Gold

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    I wish they made Viagra-like pills for women. I'd be eating them like chicklets just because.
     
  3. Mr Fantastic

    Mr Fantastic Found Nemo VIP

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  4. Bristol Chicken

    Bristol Chicken Free Range and Loving It Gold

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    [​IMG]
     
  5. PSU Shower Room

    PSU Shower Room Well-Known Member

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    This is so stupid.

    Please tell me this Even the Score group are a PR firm/lobbyists hired by Sprout Pharmaceuticals. The lawyers can start salavating now in preparation for all the lawsuits.
     
    ScottBaiosPenis likes this.
  6. ScottBaiosPenis

    ScottBaiosPenis Well-Known Member

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    cant wait to order these online and dump them into the wifes breakfast cereal
     
  7. ScottBaiosPenis

    ScottBaiosPenis Well-Known Member

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    they've had this for years its called COCAINE
     
    NyMarkNy and wife is a whore like this.
  8. Slow

    Slow My name is my name DawgShed News

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  9. NyMarkNy

    NyMarkNy VIP Extreme Gold

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    Private company so you can't buy stock. Mother fuckers.
     
    ScottBaiosPenis likes this.
  10. NyMarkNy

    NyMarkNy VIP Extreme Gold

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    The only thing women on cocaine want more than cock, is more coke.
     
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  11. PSU Shower Room

    PSU Shower Room Well-Known Member

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    NyMarkNy likes this.
  12. misslady85

    misslady85 Well-Known Member

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    One warning is to not take if you have consumed alcohol. What's the point? Nothing like some wild, drunken sex.
     
    Nibbler, Caffeinated, Wangold and 2 others like this.
  13. Tipsey Russell

    Tipsey Russell VIP Extreme Gold

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    a real man only requires a little booze


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  14. ScottBaiosPenis

    ScottBaiosPenis Well-Known Member

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    unlike this pill, a 40 of colt...

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  15. SouthernListen

    SouthernListen I don't follow the crowd. Sorry about that. VIP

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    UPS guy will appreciate that.
     
  16. ScottBaiosPenis

    ScottBaiosPenis Well-Known Member

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    im blacklisted off UPS lol
     
  17. PI Nate

    PI Nate Disenfranchised since 1984... Gold

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    Thought that was invented a loooong time ago.

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    Wangold likes this.
  18. IfTheyOnlyKnew

    IfTheyOnlyKnew VIP Extreme Gold

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    I guarantee, ANY of this would work better.... :coffee:
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    And, if all else fails, these work, too..... :c
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  19. TheMercenary

    TheMercenary Collecting Light Gold

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    It's too easy :jj: but:

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    Credit: @dawg
     
  20. Caffeinated

    Caffeinated Well-Known Member

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    A pill? Puh-leeze.

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