Addyi: Valeant's Female Libido Flop

| About: Valeant Pharmaceuticals (VRX)

Summary

Addyi has not been a very successful product despite strong demand in the sexual dysfunction market and a relatively undeserved female demographic.

The drug does not bring a unique solution to the problem. Many other catecholaminergic drugs have the exact same effect on human libido.

Addyi may set an unfortunate precedent for the FDA.

The sexual dysfunction marketplace is huge, and the smashing success of Viagra proved that there is money to be made in this niche.

source: Forbes.com

Viagra 'only' works for men (this is not entirely true), and so the female sex-drug market would seem relatively untapped and ready for a drug like Addyi to make billions. However, female sexuality is notoriously obfuscated and even politicized, leading society into the belief female hypoactive sexual desire syndrome (HSDD) is some complex problem that needs a magic pill to save the day, and that the lack of effective treatments for the condition is the result of anti-female policies and not science/economics.

Sprout sought to leverage these biases with Addyi instead of bringing a unique solution to the problem.

I believe the drugs relatively common catecholaminergic action will prevent it from having a large impact on the market and set a dangerous precedent for the FDA when it comes to the approval of libido boosting drugs.

Addyi vs. Viagra

Addyi (Flibanserin) and Viagra (Sildenafil) are often seen as similar drugs, but this could not be further from the truth. To understand the difference between flibanserin and sildenafil, you must understand the difference between an aphrodisiac and a sexual performance enhancer.

Viagra works by inhibiting PDE5 and treats sexual dysfunction by working on the physiological responses to sexual stimulus by facilitating blood flow.

1. For patients having normal mental arousal levels with poor physiological responses, this is a perfect solution to their problem.

2. However, for those with both poor mental AND physical arousal responses this is solution may be unsatisfactory.

3. For those with normal physical performance, yet poor mental arousal the drug is useless.

Because of biological differences, women are more likely to fit into the 3rd category. Such patients need an aphrodisiac - a treatment for sexual dysfunction that works on the arousal in the brain instead of its manifestations in the body.

The easiest way to achieve this effect is through either manipulating hormones or reward chemicals in the brain. Addyi was the first drug approved solely for this purpose (for males or females) by the FDA.

Why Did the FDA Even Approve Addyi?

Many find the FDA's decision to approve Addyi strange at best and a dangerous precident at worst. Most of the concerns center around the safety and efficacy of the drug; however, I do not understand why this drug was even developed, talk less of approved.

Flibanserin has been found to decrease serotonin levels and increase the levels of dopamine in the brain through an unknown mechanism. If that sounds familiar, that is because it is.

This is pretty much the same thing alcohol does (to an extent), along with stimulants like Adderal, Ritalin or Vyvanse, and street drugs like ecstasy, MDMA or cocaine.

Even prescription drugs like Valeant's (NYSE:VRX) own antidepressant Wellbutrin, and the antidepressant Segiline, can have an aphrodisiac effect because they boost dopamine. Increased sex drive is listed as a side effect of hundreds of medications that affect dopamine, the reward neurotransmitter. Many doctors prescribe these drugs to treat sexual disfuntion comorbid with depression and/or caused by a different (usually SSRI) anti-depressant.

Conclusion.

Addyi's failure to take off is not the result of bad marketing. I believe the drug would have marketed itself if it was any good.

Addyi simply does not bring any unique solution to the problem it is seeking to solve. The drug leveraged political biases to fill a role that could have been filled by numerous other medications, and I do not believe its efficacy is impressing the market.

I think it is interesting that the FDA approved a run of the mill catecholaminergic drug as a treatment for sexual dysfunction because this is a slippery slope in to 'medications' like low dose ecstasy or other libido-boosting street drugs.

On a more reasonable note, cannabis has been found to enhance intimacy. Marijuana based aphrodisiacs may be worth looking into. Read the FDA's justification for its Addyi approval here.

Further reading: "Even the Score Does not Add Up"

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I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.