Addyi – Is it Viagra for Women?
“Is Addyi the female viagra?” This is a question that we hear often from women looking for information on Addyi (Flibanserin) – the new treatment for HSDD which was approved by the FDA on August 18, 2015.
While it’s probably not realistic to think of Addyi as the equivalent of ‘Female Viagra”, it was the first FDA approved drug to help address female sexual dysfunction and boost female sex drive. What is Addyi – and how does it work? To understand this drug (formerly Flibanserin) – let’s back things up and explain the history of Addyi and how it came to be widely regarded as the first “female sex pill”.
The History of Addyi (Flibanserin)
Addyi is the new “brand name” of a drug that’s been in development as a HSDD treatment which is known by the drug name Flibanserin. Flibanserin (Addyi) was originally developed as an anti-depressant many years ago. It was noticed that some women in the studies experienced some positive benefits in their sex drive while taking Flibanserin.
Sprout Pharmaceuticals was not the original company that tried to get FDA approval for Flibanserin as a treatment for low female sex drive. The drug originally belonged to a German company called Boehringer, which unsuccessfully tried to get FDA approval for Flibanserin.
The FDA rejected the application due to questions about the drug’s efficacy and safety. Sprout acquired Boehringer Ingelheim’s rights to flibanserin in 2012, and prepared to resubmit the drug to the FDA for approval using the German company’s clinical trial data. But in 2013, Sprout twice failed to overcome FDA concerns that the drug’s risks outweigh its benefits. The FDA requested additional studies, and also said that concerns about the drug warranted a review by an independent panel of medical experts.
Despite being rejected by the FDA on three separate occasions, in August 2015 Flibanserin finally received FDA approval after intense lobbying and media coverage. The company got to this point, at least in part, because it helped drive a public campaign – orchestrated by a group called Even the Score – which leveraged the viral nature of the product and the health problem to mount a very effective PR push for an approval. After receiving FDA approval – with several conditions – Sprout Pharmaceuticals chose the brand name Addyi which was used moving forward, instead of the actual drug name Flibanserin.
It’s important to note that the FDA granted approval for this drug with several caveats and conditions. The FDA approval comes with a strict monitoring program to guard against safety risks associated with the drug.
The FDA notes that Addyi can cause severe low blood pressure, as well as the loss of consciousness—risks that are exacerbated with alcohol or certain drugs that interfere with the way that Addyi is broken down in the body. For those reasons, the FDA is requiring that patients seeking Addyi to treat Hypoactive Sexual Desire Disorder—essentially low libido— get a prescription from certified physicians who must counsel patients on the drug’s risks. Prescriptions can only be filled by pharmacies certified to dispense the Raleigh, NC-based company’s drug, and those pharmacies must receive training on the drug’s risks.
Addyi will also carry a boxed warning highlighting the drug’s risks and the FDA is requiring Sprout to conduct three post-marketing studies in women “to better understand the known serious risks of the interaction between Addyi and alcohol.” The most common adverse reactions associated with the use of Addyi are dizziness, sleepiness, nausea, fatigue, insomnia and dry mouth.
When will Addyi be available?
Addyi first became available on October 17, 2015. It’s important to note that Addyi is only available in the USA – and will only be available through pharmacies certified to sell the drug.
Addyi does come with some considerable side effects and risks – and as such only pharmacies which have been properly trained will be allowed to sell the drug.
Will Addyi be the big breakthrough in female sex drive treatments that some lobby groups suggested? It’s hard to say. Most studies have shown that female libido improvements will be modest at best while using Addyi, and there can be some ominous side effects.
However, with millions of women suffering from low sex drive – there will undoubtedly be many women willing to give it a shot. While Addyi probably won’t become the ultimate ‘Viagra for Women’ that has been suggested – it may provide an option for women that didn’t exist before.