The Food and Drug Administration approved a controversial drug meant to increase women’s desire for sex, a treatment that has rekindled a debate over the limits of medicine when it comes to human sexuality.
The drug, called Vyleesi, is an under-the-skin injection women take before sex. It’s approved for women with hypoactive sexual desire disorder, or HSDD, which is defined as a distressing loss of interest in sex.
Vyleesi’s demonstrated increases in reported desire, measured on a five-point scale, are small. But AMAG Pharmaceuticals, the drug’s manufacturer, contends that even a seemingly marginal improvement can make a major difference for women with HSDD. The drug’s most common side effect is nausea, which affected 40% of women in clinical trials, and the FDA advises women against taking more than one dose within 24 hours or more than eight doses per month.
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1200 women participated in 2 Phase 3 Trials..80% of those women wanted to continue use of Vyleesi after the trials were concluded. As for the side effects, there is a lot of misrepresentation about the severity of those being reported today. The nausea was mostly transient and did not occur after the first dose in most cases. Vyleesi was well received by almost all of the participants and dropouts from the trial were around 8%.
Consumers injecting themselves is a huge roadblock for anything but a life-saving medicine like insulin. Maybe Vyleesi could be provided in an intranasal dosage form? Absorption through the intranasal route can cross the blood-brain barrier.
The initial clinical trials involved dosing via the intranasal method. Some test subjects experienced severe spikes in blood pressure and the FDA suspended the trial. The delivery method was revised to injection to mitigate the blood pressure issue and the clinical trials resumed.
The response from the study participants concerning the auto-injector was fairly positive though. Granted, their sentiment as people desperate enough to sign up for a clinical trial might not reflect that of the patient populace as a whole, but I think investors’ worries about this are probably excessive. My understanding is that the auto-injector is relatively simple and painless.
“Regardless of treatment, the majority of participants (62.4%) rated their overall experience with the autoinjector as “very good” or “excellent,” and most participants (86.8%) reported that administering the study medication was “easy.” Slightly more participants preferred an on-demand injection over a daily pill.”
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