Q) I understand the first drug targeted at female sexual dysfunction is finally now available for sale in Canada. What can you tell me about it?
A) Addyi (pronounced AD-ee and also known by its generic name flibanserin) has recently been approved for sale in Canada after a lengthy review process by Health Canada. Addyi was first released for sale in the United States back in 2015 but has been dogged by numerous controversies leading to a long delay in getting approval from the Canadian health authorities. The delay may also be in part due to the fact that the drug has had disappointing sales volumes south of the border perhaps lessening the incentive to bring Addyi to market as quickly as possible.
Before getting into all of that, let’s talk about just what Addyi does. It has been dubbed the “pink Viagra” in reference to its effect on a female’s sex life but the term, while clever, is completely inaccurate. Viagra (and the other male erectile dysfunction pills) works by helping men who want to have sex but have difficulties getting or maintain erections. Viagra overcomes this by increasing the flow of blood to the penis. In other words it works to correct a physiological or mechanical type of problem.
Addyi in contrast, works strictly on psychological issues related to a lack of sex drive. It works on serotonin, the same brain chemical (i.e. neurotransmitter) that most of our antidepressants work to enhance. Unlike the antidepressants, Addyi is both a serotonin agonist and an antagonist meaning that it increases the effects of serotonin in some parts of the body and blocks its actions elsewhere. Addyi, to repeat, does nothing for blood flow to the female genitalia therefore, it does not enhance one’s ability to achieve an orgasm nor make sex more enjoyable for either partner.
It is approved to treat a disorder known as hypo-active sexual desire disorder (HSDD) which sounds like one of those made up conditions drug companies manufacture in order to sell more drugs. In reality however, HSDD has been recognized as a “real” disorder for nearly half a century and is the most common form of female sexual dysfunction. In a nutshell, HDSS is characterized by a chronically low sex drive (or low libido) along with a sense of distress over this.
According to Addyi’s website there is a set of 4 questions that can allow a physician to make a diagnosis of HDSS. These include:
1. In the past, was your level of sexual desire or interest good and satisfying to you?
2. Has there been a decrease in your level of sexual desire or interest?
3. Are you bothered by your decreased level of sexual desire or interest?
4. Would you like your level of sexual desire or interest to increase?
If you answer yes to all four of those questions and the reason for those affirmative responses can’t be blamed on some other reason (such as a medication you may take, dissatisfaction with your partner, the fact that the act of intercourse itself is painful for some…), a diagnosis can be made. It is estimated that 1 in 10 adult females meet this diagnosis.
So, with such a large potential pool of patients, just why has Addyi sold so poorly in the States. The answer is four-fold. First, the drug’s success rate in reversing this condition is so-so at best. About one in 11 pre-menopausal women report one additional satisfying sexual event every one or 2 months while taking Addyi as compared to those on a placebo. I guess that’s progress for a few lucky patients but it’s not great. What’s worse is that it works even less well in post-menopausal women.
The second issue with Addyi is that it needs to be taken every night, rather than just when needed as is the case for its male counterparts. Many people do not like having to take pills so this has been a major turnoff for a lot of prospective females.
Thirdly, the drug is far from cheap. It costs about $280 a month and is not covered by the Ontario government nor many private employer sponsored drug plans.
Lastly, Addyi comes with some significant safety issues. First it interacts with a large number of drugs, both prescription and over the counter ones (such as fluconazole, the oral pill used to treat yeast infections) as well as grapefruit which could lead to dangerously high levels of Addyi in your system. These interactions can be managed by your health care team but it may limit the options you can safely take in treating such common conditions as infections, birth control, epilepsy and high blood pressure. As well, like so many other pills, Addyi can have some nagging although uncommon side effects such as nausea, dizziness and drowsiness amongst others.
However, the big hang-up with Addyi is its potential to dramatically lower your blood pressure. This has led to some women fainting while taking the pill and has led to restrictions on alcohol use. Originally, when it was released in the States, Addyi came with the strongest warning that can be given to a drug (ominously called a black box warning) telling females to abstain from alcohol if taking this drug. This year, those restrictions were softened so that women are now advised to discontinue drinking alcohol at least 2 hours before taking Addyi at bedtime or to skip their dose that evening if they already have consumed an alcoholic beverage. As well, it is strongly recommended that after taking Addyi no more alcohol should be consumed until at least the morning after.
There are some health experts who feel this lessening on these restrictions is not warranted and remain concerned about the use of alcohol with this drug. The problem results from the ability of alcohol to intensify the lowering of blood pressure Addyi may cause on its own increasing the risk of recipients fainting or becoming exceedingly dizzy and injuring themselves. There are reasons to believe these side effects are more dramatic in those who are moderate drinkers as opposed to heavy consumers of alcohol. It was for reasons such as this that the FDA twice failed to approve Addyi for sale before finally allowing its marketing in 2015.
All in all, Addyi may be a great answer for a few females but it certainly comes with its “warts” and does not have a great track record of working in most who take it.