Pink Viagra approved
2015 was a significant year for Sexologists worldwide. After a long and controversial process, the US Food and Drug Administration (FDA) approved the first-ever drug aimed at boosting female libido. The medication, called flibanserin, will be sold under the brand name Addyi, also known as “pink Viagra.”
Pink versus Blue
Just to clarify: the pill is not pink and has nothing in common with the blue pill, Viagra. Viagra works “below the belt”, so to speak, and Addyi works in the brain. So let’s rather not call it Pink Viagra, but rather just call her by her real name Addyi.
Q: What is this new drug, flibanserin?
Flibanserin is an antidepressant that failed to help depression in clinical trials, but was noted to have improved sexual health outcomes. It’s not uncommon for a drug to be developed for one purpose, then approved for another. Sildenafil (Viagra) was originally developed to lower blood pressure, but failed those trials. The benefit of both of these drugs was discovered by accident. However, flibanserin has now been studied for its effects on sexual health for nearly a decade.
Q: How filbanserin work to boost a woman’s libido?
Researchers think that flibanserin restores some of the chemical imbalances that affect sexual desire disorders. Most people have heard of antidepressants known as selective serotonin reuptake inhibitors, like fluoxetine (Prozac). SSRIs can have negative sexual side effects: reduced libido or erectile dysfunction, suggesting that serotonin plays an important role in sexual desire and excitation. Flibanserin affects serotonin but in a different way than SSRIs. It stimulates one type of receptor while blocking another. It also increases dopamine in the body. Dopamine is known to have positive effects on sexual health.
Q: What are flibanserin’s benefits and drawbacks?
This is the first medication approved to treat sexual desire disorders. While many people think desire is more psychosocial than biological, there are clear biological processes that affect sexual desire and function. Flibanserin was shown to have a modest improvement over placebo in increasing desire. Women taking the drug had up to two more satisfying sexual events (SSEs) each month, compared to the placebo’s increase of one more SSE a month.
It is important to note it is very hard to overcome the placebo effect when studying drugs; people often improve on placebo alone. The controversy over flibanserin focuses on the degree of benefit. Is one more sexually satisfying event each month enough of a benefit? For many women, this is a significant increase and should not be discounted, given how important sex can be in a relationship. Overall desire, very important to many women, scores also increased in the most recent trials.
Drawbacks: there are adverse effects, as there are with all medications. The major adverse effects are dizziness and drowsiness, which can affect about 10-15% of women taking the medication. This is not significantly different from the widely prescribed SSRI antidepressants. We don’t yet have long-term data on other potential risks, including cancer. It should be pointed out, however, that Viagra was approved with six months of safety data. Most studies on flibanserin have one to two years of safety data.
Another drawback is the concern that this drug will simplify the complex factors that affect women’s sexual health. Many people feel that this is just a ploy by pharmaceutical companies to cash in on a problem that is widespread, and cannot be treated pharmacologically.
Q: Why is flibanserin such big news?
Up to 40% of women report having sexual problems, and about 12% find the problems very bothersome. This equates to millions of women who suffer from female sexual dysfunction, the most common being hypoactive sexual desire disorder (HSDD) or loss of libido.
Women are still in the shadows when it comes to talking about sexual dysfunction. They’ve been told for years that their only options are expensive therapies, including psychotherapy, hormones, and supplements. The FDA’s standard of approval for drugs to treat sexual dysfunction in women is significantly higher than for those to treat men’s sexual health concerns.
Just as Viagra opened the door for men to talk about sexual health, the hope is that flibanserin will allow women to discuss this often highly distressing problem and have an option for treatment. This is an important development for women and for those who treat them.
Addyi is available in the USA, but it might be a few years before the MCC* will make it available in South Africa.
*The Medicines Control Council applies standards laid down by the Medicines and Related Substances Act, (Act 101 of 1965) which governs the manufacture, distribution, sale, and marketing of medicines. The prescribing and dispensing of medicines is controlled through the determination of schedules for various medicines and substances. All medicines for human use are subject to this law, including complementary and complementary biological medicines.
Dr Elna McIntosh, sexologist and Retire Successfully Retirementor