Monday, June 24, 2019

Better than roses?

On June 21, the FDA approved for marketing bremelatonide (trade name Vyleesi) to treat acquired generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
While I expect push-back commenting on this topic as a male, I am also a physician, and I think this represents a flaw in our drug-approval process. HSDD is defined in the psychiatrists’ “bible” of DSM (The Diagnostic and Statistical Manual of Mental Disorders is the handbook used by health care professionals in the United States and much of the world as the authoritative guide to the diagnosis of mental disorders) as low sexual desire that causes marked distress and/or interpersonal difficulty and which is not due to a co-existing medical or psychiatric condition. It can be diagnosed in both men and women, though I am unaware of any products marketed or in development to increase male sexual desire. Vyleesi is not the first medication for improving women’s sexual desires. Addyi, a drug approved by the FDA in 2015, also improves women’s sexual desires by working kind of like an anti-depressant. However, earlier this year, the FDA issued new safety orders mandating that the drug’s labeling include a boxed warning — the agency's strongest warning — after reports of concerning side effects, including severely low blood pressure and fainting, especially when used with alcohol. Many women’s groups were and remain unhappy that Addyi was approved as quickly as happened.
Changes in sexual desire are natural and may come and go depending on personal events or partner-related issues. When the lack of interest in sexual activity lasts longer than six months and causes distress, however, the criteria for a sexual desire disorder may be met. There are many reasons other than a “medical disorder” such as HSDD to cause decreased interest in sex. These may include, in part, negative attitudes about sex, relationship difficulties (poor communication, abuse), stresses such as financial difficulties, job loss, bereavement, etc., history of emotional or physical abuse, alcohol use, worry about children wandering in or simply a partner’s poor hygiene.
Leaving this all aside, how wonderful is Vyleesi? Is it a “cure?” The drug was approved based on two trials that compared the active drug in different doses versus placebo. The drug must be injected under the skin of the abdomen or thigh at least 45 minutes before anticipated sexual activity (so much for spontaneity!). Possibly showing the power of placebos, the trials found that 25% of women using active medication had an increase in their sexual desire scores, compared to 17% of those using placebo. 35% of women who used the drug had a decrease in their distress score versus 31% of those using placebo. While the manufacturer will tout the “47% greater improvement” experienced by women using the active drug (17% increased to 25%), I think a more realistic viewpoint is that the drug benefitted 8 out of 100 women who used it.
What about side effects? About 40% of the women in clinical trials experienced nausea, and in 13% the nausea was severe enough to require medication. It also caused a transient (up to 12 hours) increase in blood pressure, meaning it should not be used in women with high blood pressure or cardiovascular disease. The drug will go on sale in September, and a price has not yet been announced.
Worth it? You can decide for yourself, but I’d try roses first.

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