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Is the “Pink Viagra” Finally Here?

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HSDD is acquired when it develops in a patient who previously had no problems with sexual desire.

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After lengthy discussions with the agency, the company has agreed to track over 3,000 women for more than a year to detect potential side effects. Even if the gel turns out to be safe, Emory University Professor Kim Wallen said it's unlikely to prove effective. "There have probably now been 50 studies on different kinds of testosterone regimens, and they all produce minimal or no effect" on sexual desire, according to Wallen. "This is a case where the pharmaceutical industry is looking in the wrong place." Wallen still believes there could be pharmaceutical solutions to low sexual desire, possibly with other hormones like estrogen. But he says the industry's search for a magic pill oversimplifies the problem.

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Sexuality is influenced by so many factors — including physical health, quality of relationships and lifestyle — that it's unrealistic to assume a drug could address millions of different cases of low libido. "There are lots of reasons that people, both men and women, experience low sexual desire," Wallen said. "And to lump every individual into this group as potentially being amenable to drug therapy seems ill-advised." Some call it "female Viagra", a little pink pill meant to help some women awaken their sex drive. Health reporter Erin Billups takes a look at the medication and what it may mean for the future and filed the following report. Sexual dysfunction is a favorite topic of comedians, but for most women dealing with sexual desire disorders it's no laughing matter. HSDD is generalized when it occurs regardless of the type of sexual activity, the situation or the sexual partner.

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Addyi (Flibanserin) can cause severely low blood pressure (hypotension) and loss of consciousness (syncope).

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These risks are increased and more severe when patients drink alcohol or take Addyi with certain medicines

Episode Transcript

For the first time, there is a new drug on the market for these women - Flibanserin - from Valeant Pharmaceuticals. "This is for the patient who has all the, what we call the right kind of formula for being in a healthy sexual relationship and just doesn’t want to have sex and buy female viagra is bothered by that," explains Dr. Elizabeth Kavaler, a urologist at Lenox Hill Hospital. Some have dubbed it the "female Viagra" but it works differently than the little blue pill. "Flibanserin is a medication that works on the brain, on the neurotransmitters of the brain.

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And it modulates the serotonin and the dopamine levels in the brain so that there is a sense of good feeling," says Kavaler. It's approved for women 50 or younger, but most experts like Kavaler agree, female sexuality and desire is complex and in most cases can't be fixed outright with a pill. Which is why the treatment is seen as controversial. "The idea that you’re going to give a woman a drug so she wants to have sex with you is disturbing to a lot of women," Kavaler points out. Medical ethicist Arthur Kaplan says it's just the latest trend in pharmaceutical innovation - medication that affects the brain. (known as moderate or strong CYP3A4 inhibitors) that interfere with the breakdown of Addyi in the body.

Risk Explanation Recommendations
Heart Problems Can stress cardiovascular system Consult doctor if cardiac issues
Drug Interactions Interacts with nitrates, certain antihypertensives Avoid concurrent use
Overdose Can cause severe hypotension, priapism Follow prescribed dosage
Allergic Reactions Rash, swelling, difficulty breathing Seek medical help immediately
Age Restrictions Not recommended for under 18 Use only as prescribed

Because of the alcohol interaction, the use of alcohol is contraindicated while taking Addyi.

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Despite a modest uptick in sexually satisfying events reported in the studies, panelists said the drug's benefits were not strong enough to warrant approval as a daily pill for women. The attempt to trigger sexual interest through brain chemistry is the drug industry's latest approach to find a female equivalent viagra medicine to the blockbuster success of Pfizer's erectile dysfunction drug, Viagra. Since that drug's 1998 launch, more than two dozen experimental therapies have been studied for so-called "female sexual dysfunction," a market worth an estimated $2 billion. Initially, Pfizer tested Viagra on women, hoping that the drug's ability to increase blood flow to the genitals would increase libido. When that didn't work, drugmakers turned to hormones, including testosterone.

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In 2004, an FDA panel rejected Procter & Gamble's testosterone patch, Intrinsa, due to unknown risks from long-term use. Two years earlier a massive government study found that hormone replacement therapy in postmenopausal women increased heart disease and breast cancer, raising concerns about the safety of all hormones. Will search be called to a halt?Decision Resources analyst Alasdair Milton says that after year of disappointing results, the search for "female Viagra" may be winding down. "In this day and age, are you really going to spend a significant amount of money developing these compounds if you're not going to get a return on your investment?" But experts who have watched the drug industry's dogged pursuit of a female dysfunction drug are not convinced the end is in sight. Dr. Health care professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing Addyi.

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The flibanserin setback was in contrast to Boehringer's success in pioneering a new blood thinning pill for a market that rival Bayer said could be worth $15 billion. A U.S. advisory panel last month recommend clearance of Boehringer's Pradaxa pill for preventing strokes in patients with a type of irregular heart beat. Reporting by Ludwig Burger; Editing by Dan Lalor Our Standards: The Thomson Reuters Trust Principles. A "pink pill" to boost women's sex drive remains elusive after a decade of searching by some of the world's biggest drugmakers.

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A panel of health experts on Friday rejected the latest offering submitted for federal approval to treat lack of female libido: an antidepressant drug that failed to increase sexual desire in two studies. The Food and Drug Administration's panel of reproductive advisers voted unanimously that the benefits of the pill from Boehringer Ingelheim did not outweigh side effects, including fatigue, depression and fainting spells. "I am convinced that women's sexual health is important and that many women suffer from sexual dysfunction, but I'm not convinced of a clinically meaningful benefit for this drug," said panelist Paula Hillard, a gynecologist from Stanford University School of Medicine. The FDA will make its own decision on the drug in coming months, though it usually follows the advice of its panelists. The drug flibanerin, which acts on serotonin and other brain chemicals, was originally studied as a depression therapy, but then repurposed as a libido pill after women reported unusually high levels of sexual satisfaction. Addyi is also being approved with a Boxed Warning to highlight the risks of severe hypotension and syncope in patients who drink

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alcohol during treatment with Addyi, in those who also use moderate or strong CYP3A4 inhibitors, and in those who have liver impairment.

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Leonore Tiefer, a psychiatry professor at New York University who runs a private sex therapy practice, said drug companies may target narrower groups of women to find an effective therapy, but won't give up the search anytime soon. "I don't see that there's any incentive for the companies to stop, the market is just too big," said Tiefer. 43 percent of women experience sexual dysfunctionDrug companies frequently cite a 1999 survey in the Journal of American Medical Association that found 43 percent of U.S. women had some type of sexual dysfunction, though more rigorous, in-depth surveys have put the figure closer to 10 percent. The field of potential competitors in the market has narrowed considerably over the years.

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Currently the only company with a drug in late-stage development is BioSante Pharmaceuticals Inc., a small specialty drugmaker developing a testosterone gel called LibiGel. According to company executives, more than 1.8 million women received prescriptions for men's testosterone gel last year, suggesting a significant market. While currently marketed testosterone gels are designed to treat low hormone levels in men, doctors are free to prescribe them for alternate uses. "That shows you doctors are willing to write prescriptions for testosterone off-label and women are willing to take it," said BioSante Chief Financial Officer Phil Donenberg. But FDA approval of the company's LibiGel is far from certain. In addition, the FDA is requiring the company that owns Addyi to conduct three well-designed studies

Focus Area Potential Advancements Estimated Timeline Remarks
Improved Bioavailability New formulations for faster onset 2-3 years Enhancing user experience
Reduced Side Effects Safer compounds, fewer adverse reactions 3-5 years Better safety profile
Alternative Delivery Sublingual, transdermal patches 4-6 years More discreet, convenience-focused
Combination Therapies Combining sildenafil with other agents 2-4 years Increased efficacy, tailored treatments
Market Expansion Entry into emerging markets Ongoing Broader access globally

in women to better understand the known serious risks of the interaction between Addyi and alcohol.

User Name Age Effectiveness Side Effects Experienced Satisfaction Level Notes
JohnD 42 Very effective None High Improved confidence
LisaM 35 Moderate Headache, flushing Satisfied Needs some time to act
MikeS 50 Excellent None Very satisfied Long-lasting, discreet packaging
KarenP 29 Slightly effective Dizziness Neutral Might need higher dose

Addyi is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, but the mechanism by which the drug improves sexual desire and related distress is not known.

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"We have pills that are obviously starting to do that. That's what a lot of the things that are calming you down do and I think we'll see more of that. It has its own risk, you're mucking around in the brain, you're changing the chemistry like sex. Obviously we could try for this with appetite in obesity and things like that," says Caplan. Little more than a third of women in clinical trials saw an increase in sexual desire.

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Still, Kavaler says it's better than nothing. "It’s refreshing that we can have these conversations and that women can start to talk about their sexuality and their concerns. Even if they are viagra alternative uk not necessarily candidate for this medication," she says. Flibanserin is approved for use for those diagnosed with hypoactive sexual desire disorder (HSDD) or inhibited sexual desire (ISD) is considered a sexual dysfunction and is characterized as a lack or absence of sexual fantasies and desire for sexual activity. HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. It is dosed at bedtime to help decrease the risk of adverse events occurring due to possible hypotension, syncope and central nervous system depression (such as sleepiness and sedation).

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