For decades, hundreds of pharmaceutical companies have chased after a ‘female Viagra,’ trying to land on something that would cure millions of women from sexual dysfunction. In 2015, the first drug finally got approval from the FDA to treat low sexual desire in women, to mixed reviews and concerns about how well it really works and potential side effects. A new drug called Vyleesi has just been passed by the FDA, and it is raising stirrings of excitement and controversy. Here are five important things you need to know about Vyleesi, the new sex drug for women.
1. What is Vyleesi and How Does it Work?
Vyleesi, also known by its generic name bremelanotide, is a medication designed to treat hypoactive sexual desire disorder (HSDD) in premenopausal women. HSDD is a condition characterized by a persistent lack of interest in sexual activity, causing distress or difficulty in interpersonal relationships. It is believed to affect around 1 in 10 women.
Vyleesi works by targeting the melanocortin receptors in the brain, which are involved in the regulation of sexual desire. It increases the release of hormones, such as oxytocin and dopamine, which are associated with pleasure and sexual arousal. The medication is self-administered in the form of an injection, which is taken 45 minutes before sexual activity.
2. How Effective is Vyleesi?
Assessing Vyleesi’s effectiveness has been a subject of ongoing debate. Clinical trials involving over 1,200 women revealed a modest improvement in sexual desire and distress related to low libido. Specifically, women who received Vyleesi reported a 0.3 to 0.4 increase on a sexual desire scale, as compared to the placebo group’s decrease of 0.1. Moreover, roughly 25-30% of participants in the Vyleesi group experienced a clinically meaningful improvement in their distress related to low libido.
Despite these relatively positive results, several critical factors should be considered. For instance, comparisons with placebos create challenges in isolating the precise impact of Vyleesi, as improvements in the placebo group can potentially be attributed to factors such as heightened attention, expectation, or psychological engagement. Furthermore, the long-term efficacy and safety of Vyleesi remain to be fully established, necessitating further research.
3. What are the Potential Side Effects of Vyleesi?
As with any medication, there are potential side effects associated with taking Vyleesi. The most common side effects reported in clinical trials were nausea, flushing, and injection site reactions. Some women also experienced an increase in blood pressure, which could be a concern for those with underlying cardiovascular conditions.
There have also been reports of darkening of the skin, particularly on the face and chest, in women who took Vyleesi. This side effect is not harmful but may be a concern for those who are self-conscious about changes in their appearance.
4. Who Should Not Take Vyleesi?
While Vyleesi has the potential to help many women with HSDD, it is not recommended for everyone, and there are certain groups of people who should not take the medication. According to the FDA, women with uncontrolled high blood pressure or heart disease should avoid Vyleesi, as the drug may exacerbate these conditions. Additionally, women with a history of melanoma or other skin cancers should also exercise caution, as Vyleesi may increase the risk of these cancers recurring.
Pregnant or breastfeeding women should also avoid Vyleesi, as there is limited research on its effects on fetal development or breast milk. Furthermore, the drug is not recommended for use in men or postmenopausal women, as its effects on these groups have not been studied. It is crucial that healthcare providers carefully consider these factors when determining whether or not to prescribe Vyleesi to their patients.
5. What are the Criticisms Surrounding Vyleesi?
Despite its approval by the FDA, Vyleesi has faced criticism from some members of the medical community. One of the main criticisms is that the drug’s effectiveness is not significant enough to justify its potential side effects and the inconvenience of self-administered injections. In clinical trials, Vyleesi has been shown to increase sexual desire and decrease distress related to low sex drive, but the magnitude of these effects has been relatively small. Some critics argue that these modest benefits do not outweigh the risks of side effects such as nausea, flushing, and headaches.
Another concern is the lack of research on Vyleesi’s interactions with other medications and substances, such as alcohol. The FDA has not tested Vyleesi in combination with these factors, which may lead to unpredictable interactions and raise safety concerns. This lack of information is particularly problematic given that many women with HSDD may also be taking other medications for various conditions.
Lastly, the high cost of Vyleesi has been a subject of criticism. Estimated to be around $400 per dose, the drug could be a significant financial burden for many women, especially those without insurance coverage. This cost may make it difficult for some women to access the medication, potentially limiting its impact on improving the lives of those with HSDD.
Conclusion: Women with low sexual desire can now hope for a breakthrough with this new drug called Vyleesi. While generally shown to be effective in increasing sexual desire, overall effectiveness and possible side effects are still debated. It’s important that women discuss their options with their healthcare provider and weigh the risks and benefits before deciding to try Vyleesi. As in the case with every medication, one needs to weigh every factor to come up with a decision that would be most suitable according to his or her needs and circumstances.
