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'Viagra' For Women

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Dr Greggory Pinto

By DR GREGGORY PINTO

The United States Food and Drug Administration (FDA) on June 21 approved the new “female Viagra”, a sexual libido enhancing medication called Vyleesi. Vyleesi is not a pill; it is a self or partner administered injectable that should be given 45 minutes before sexual intercourse. It has been recommended that Vyleesi should not be administered more than once in a 24-hour period and it should not be used more than eight times in a given month.

Vyleesi is the second FDA-approved sexual libido enhancer for women, following the approval in 2015 of the drug Addyi. Addyi is a pill that works by modifying serotonin levels in the brain.

Both medications are prescribed to treat premenopausal hypoactive sexual desire disorder (HSDD) in women.

HSDD is a condition characterised by low or non-existent female sexual desire. Female hypoactive sexual disorder may occur in 10 percent to as many as one third of premenopausal women. The main feature of this disorder is the deficiency or absence of sexual desire of sexual intercourse and the deficiency or absence of sexual fantasies in women that leads to severe distress and relationship problems; often negatively affecting the quality of these afflicted women’s lives. HSDD is not caused by co-existing medical conditions, such as diabetes or by any psychiatric conditions or as the result of other medications that are being taken.

Female desire is complex and multifactorial, and such it is often difficult to evaluate and interpret. Female sexuality can’t be measured in the same way as the sexual desire of men, as simply put, either a man gets an erection and maintains it or he does not.

Vyleesi, also known as bremelanotide, is not truly a female version of Viagra, as Viagra enhances the blood supply to the penis. Vyleesi works by activating melanocortin receptors that are involved in multiple brain functions including regulating moods and cognitive thoughts. The medication is a synthetic hormone that activates important brain receptors involved in sexual responses by reducing inhibition and increasing excitation of neurons. The complete pathway by which Vyleesi works, is still not completely understood.

Vyleesi has not yet been approved for use by postmenopausal women, but trials continue involving such women. Vyleesi has been evaluated in scientific trials by having participants fill out sexual desire score and sexual distress score questionnaires, which are highly subjective.

The effectiveness of Vyleesi was studied in two 24 weeks randomised, double blind, placebo controlled trials involving more than 1,200 premenopausal women with HSDD.

Female sexuality and desire is very complex and there are many factors that contribute. Unfortunately, female sexuality remains a grossly understudied condition. Low sexual desire in premenopausal women might be secondary to external factors such as marital strife, financial stressors, marital infidelity, emotional or physical abuse within the relationship or poor body self-image, amongst multiple potential causes.

Simply prescribing medication to all women with low sexual desire, greatly underestimates the potential complexity of the condition. The measured success of Vyleesi has been underwhelming thus far, but for women living in severe distress because of low sexual desire, any small improvement in sexual desire may provide a substantial improvement in the quality of their lives.

Most women, like their male counterparts, rarely seek medical urological assistance for sexual dysfunction, due to embarrassment and lack of understanding that medical treatment does exist to improve the quality of one’s lives.

Many women have low desire for sexual intercourse due to them having stress urinary incontinence, whereby they uncontrollably leak urine with any exertion, including sexual intercourse. As many as one in four women have a urinary issue that negatively impacts the quality of their lives and in turn potentially can negatively impact their sexual desire and happiness.

Modern urology provides pharmaceutical treatments, physiotherapy and minimally invasive procedures that can effectively treat all female urinary issues. Seek confidential, compassionate and comprehensive urological care for any female or male sexual dysfunction and/or urinary complaint.

• Dr Greggory Pinto is a Bahamian urologist who has trained in South Africa, Germany and France. He is a member of the European Association of Urologists. Dr Pinto can be reached at Urology Care Bahamas at the Surgical Suite, Centreville Medical Centre, Collins Avenue and Sixth Terrace. Call (242) 326-1929, e-mail:welcome@urologycarebahamas.com, or visit the website, www.urologycarebahamas.com.

Comments

dwrightsd 2 months, 2 weeks ago

Vyleesi (bremelanotide) actually has a long and interesting history. It started as a sunless tanning product (Melanotan 2) which was administered via a nasal spray. When the male test subjects experienced spontaneous erections Palatin decided that might be a more interesting product and modified the molecule to eliminate the tanning part and keep the libido part. The product, PT-141, is sold around the world and has been used by a select number of men and women to enhance their sexual experiences safely for years. The US FDA banned it because the nasal spray approach caused significant blood pressure increases but the subcutaneous injection approach is considered safe because the dosing is better controlled.

There is no medical question that given the appropriate dose bremelanotide will result in very real physiological changes related to sexual arousal in men and women. One concern that I have with the choice of AMAG to go with the 1.75mg dose in the autoinjector is that it may be insufficient for some women who will not get the full arousal effect with less than 2.0mg. They chose this as a compromise between efficacy and the side effects of nausea that some women experience with the initial uses. There are actually pilot studies underway to determine if Vyleesi can be taken with Zofran if needed to eliminate the nausea. This was not an option with the clinical trials because it would have confounded the results. The nause is reduced or disappears with additional doses as the body adjusts.

What has fascinated me about this class of drugs is the reaction of many women and men that this drug should not be approved EVEN IF IT WORKS! The FDA explicitly noted in their Prescribing Guidelines that it should not be prescribed to improve sexual enjoyment. Who the hell is the FDA to tell women that they shouldn't be able to improve their enjoyment of sex if they are informed and it is deemed safe? The question that remains is: Will women be cowed by the matriarchy and patriarchy into once again suffering in silence for their illicit desires or will they take control of their bodies and decide for themselves how they want to experience life. It will not work the same for everybody and may not be the answer for some. There is a strong interest by postmenopausal women for a drug like this and further study is needed to ensure that issues of age related hypertension or low female hormone levels don't reduce its safety or efficacy metrics. The final arbiters of whether Vyleesi succeeds or not should be the women who try it and determine if it improves this aspect of their lives not the pundits and stock analysts and medical experts that have never even tried the drug.

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