The Little Pink Pill - Addyi

 

 

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Addyi - Concerns mount over the 'Little Pink Pill'.

Millions of women around the globe suffer from either female sexual dysfunction or low libido. For many years, the spot light has been on men - and not on the estimated 40% of women who suffer from HSDD or low female sex drive. In 2015 women with low sex drive were finally given some hope when the FDA approved the drug Flibanserin as the first prescription drug to treat low libido in women. Sold under the brand name "ADDYI" - the media quickly dubbed the medication 'the little pink pill' - a reference to Viagra, the ED drug for men which is often referred to as the little blue pill.

While Addyi is in fact a pink pill - that's where the similarities end. Addyi works in a very different way, and calling it 'Viagra for Women' is really not accurate at all. Though it’s often been nicknamed the “female Viagra,” the two drugs function in very different ways—Viagra aims to enhance performance whereas Addyi aims to balance chemicals in the brain that correlate to sexual desire. Still, researchers have only a rough sense of what the drug does to the brain. Addyi is a psychotropic medication - it acts specifically on serotonergic neurons in the brain, and has indirect effects on dopamine and norepinephrine.

Now that the drug has been available for about six months, new information and studies on its effectiveness continue to roll in, and there is mounting concern that the safety of this product questionable, and not worth the possible health risks for a drug with extremely moderate benefits. This article will try and address two of the primary concerns regarding the 'little pink pill' - is it safe - and does it really work.

 

VIDEO - Why isn't the Little Pink Pill selling?

 

 

The Little Pink Pill...Does Addyi really work?

Addyi first became available in October 2015 with little fanfare - due in part to the fact that as part of receiving FDA approval - Sprout Pharmaceuticals (the maker of ADDYI) agreed not to advertise the drug on TV or radio for 18 months after its launch. The drug has now been on the market for about 6 months - and recent studies are now out which indicate that Addyi offers limited gains in boosting female sexual desire.

Addyi patient studies are in - and it's not looking great for the little pink pill. After a ton of controversy, the female libido pill Addyi is finally available by prescription, which means that studies of patients using Addyi are starting to trickle in. One such study, which pooled the data of eight different studies totaling approximately 6000 women taking it, found that they reported only an additional "one-half of one satisfying sexual encounter a month" using Addyi. In other words, it didn't even provide an average of one extra really good sex session per month.

Ironically, one extra satisfying sexual encounter a month was all the makers of Addyi needed to get it approved by the FDA. It was previously rejected twice, but last year, after coming up with clinical trials that showed women experienced an average of one extra satisfying sexual encounter per month, in addition to the two-to-three they were already having, Addyi got its approval. Clinical trials also demonstrated that Addyi increased levels of desire — but only by a measure of .3 points on a scale from 1.2 to 6.0. Plus, side effects of the drug include dizziness, sleepiness, nausea, and fatigue, and the side effects can be heightened if you're consuming alcohol while taking Addyi.

 

Is Addyi safe?

Almost everyone involved in the discussion about Addyi agrees that this drug does carry some degree of risk to women's health - and it was for this reason that the FDA twice rejected the drug before finally giving approval on the 3rd application. Interestingly, no changes were made to the drug between the third application and the one which preceded it - which was rejected by the FDA.

Addyi carries a boxed warning, the FDA's strictest, and women have to sign an agreement acknowledging the risks. The largest U.S. health benefit managers have questioned its effectiveness and potential side effects."It's of modest efficacy at best, it's not particularly safe," Express Scripts Holding Co. Chief Medical Officer Steve Miller said last month, adding the benefits manager put the pill in its "non-preferred" category based on its clinical benefits. Rival pharmacy manager CVS Health Corp. is concerned about Addyi's "overall relatively insubstantial evidence around efficacy," and hasn't added it to its formulary, or list of approved prescription medicines, according to Chief Medical Officer Troyen Brennan. "We are looking harder at the data," Brennan said.

Because Addyi acts on the central nervous system, it falls in the limbo space between a psychiatric drug and a treatment prescribed by a gynecologist. The fact that doctors have to be specifically trained and certified to prescribe Addyi means it has not been widely available for many women who might want to try it. Also, pharmacies which dispense the drug must also be certified to sell the drug - making it quite hard to acquire. Many potential patients have been put off by the negative side effects associated with the drug, and combined with the extremely high price tag - upwards of $850 for a one month supply - many women are avoiding this female libido drug altogether. While the long-term safety of Addyi remains to be seen - the potential health risks seem large compared to the small amount of improvement the drug has been able to provide.

 

The little Pink Pill - Conclusion.

All said, we feel that Addyi - the little pink pill - is likely to disappoint most women seeking to increase female libido or improve their sex drive. The marginal improvement it has shown for a small percentage of women is far overshadowed by the significant health risks and many negative side effects. Although the little pink pill is a disappointment as the next female viagra - several natural female libido boosters are available and have been in widespread use for a number of years. These herbal libido enhancers have proven to be extremely safe and very effective for the vast majority of women who have tried them. For more information and reviews of the little pink pill - read this linked article.

 

 

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