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Addyi drug maker Sprout conducted three post-approval studies that show that alcohol is not a problem
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Women using the Addyi female libido pill no longer need to avoid alcohol, regulators have stated.

Previously, Addyi came with the warning to stop two hours before he swallowed the pill or to skip the pill if they had drunk a few drinks.

But on Thursday, the US Food and Drug Administration noticed that studies conducted by the drug developer, Sprout, showed no need for such a warning.

Sexual health workers greeted the service as a victory for women.

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Addyi drug maker Sprout conducted three post-approval studies that show that alcohol is not a problem

Addyi drug maker Sprout conducted three post-approval studies that show that alcohol is not a problem

The small pink pill was first approved in 2015 and remains the only FDA-approved treatment for hypoactive sexual desire disorder (HSDD) in pre-menopause women.

Unlike Viagra, which increases blood flow to a man's penis, Addyi (the brand name for flibanserine) targets the brain with similar effects to an antidepressant.

It stimulates dopamine to boost motivation and excitement, and soothes serotonin, the neurotransmitter that makes us self-aware.

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The drug has many critics: a significant proportion of doctors say that we do not know enough about the female sexual desire to & # 39; fix it & # 39; with one pill.

The American Sexual Health Association, a 100-year-old non-profit source of sexual health information, says HSDD affects a staggering one in ten women – and ASHA CEO Lynn Barclay told DailyMail.com visits to the HSDD page on their website are the latest years and months.

However, many health professionals wonder if HSDD is real.

And there is growing concern about antidepressants in general and how difficult they can be to forgo.

This skepticism has created a fertile breeding ground for cannabis entrepreneurs, who thrive in gray areas of medicine, to sell marijuana as a & # 39; natural & # 39 ;, less risky solution for women without libido.

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But many sexual health practitioners and advocates say they are just happy to be able to offer some tangible relief to women without reservations.

& # 39; Women are really looking for information here & # 39 ;, Barclay said.

& # 39; I think women unfortunately think that what happens to them happens to them and that nothing can be done about it. But Addyi might be something. & # 39;

The reason why an alcohol warning was hit on Addyi in 2015 was because Sprout had not sufficiently studied the drug's interaction with alcohol.

As a result, the FDA allowed the drug onto the market, but with a warning, and ordered the company to conduct three post-approval studies, which is fairly common with drug and device approvals.

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Sprout has conducted three investigations.

The first one lasted a week, with 24 women taking Addyi or a placebo, and on two of the days that some had a few alcoholic beverages with dinner, she took their pill a few hours later. Sprout wanted to see if there was a risk of fainting; in this scenario that was not the case.

The second involved 96 women, who had three drinks, did not eat much and then took Addyi & # 39; in the morning. Again, there was no risk of fainting and the blood pressure was stable, but some felt weak.

In the third woman, 64 women received Addyi or a placebo for 10 days. On four of those days (day four, six, eight and ten) they had a few alcoholic drinks, varying hours before they took their pill. Again, there were no obvious side effects.

Dr. Diana Zuckerman, president of the National Center for Health Research, said the studies leave many questions unanswered.

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& # 39; Some women drink every day or almost every day, but in the studies only women drink one or two drinks on some days, but no others, & # 39; said Dr. Zuckerman DailyMail.com.

& # 39; As a result, we do not know what happens if a woman drinks daily or almost daily, or one of those days is considered excessive drinking or not. & # 39;

But the bigger question that still exists, says Dr. Heart sugar is whether Addyi works really well.

The turnover was disappointing, so Sprout bore half the price in the summer of 2018.

Dr. Zuckerman thinks this may be due to the fact that, even in the clinical trials, the drug did not work much better than the placebo.

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& # 39; The original Sprout studies only found a greater benefit than placebo when they changed the way they asked women about their frequency of & # 39; satisfactory sexual experiences & # 39; to report, with a less accurate measurement, & # 39; said Dr. Heart sugar.

& # 39; We think the poor sales of Addyi reflects the fact that it is ineffective (in addition to the excessive costs and concerns about alcohol).

& # 39; The loss of libido in women is a major health problem, but it may or may not be something that can usually be solved with medication.

& # 39; Taking Addyi every day is tricky and expensive.

& # 39; If the placebo effect is over, why would a woman continue to pay for a product that she doesn't actually work for? & # 39;

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