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Sunday, June 23, 2019 11:14:48 AM
"The effectiveness and safety of Vyleesi were studied in two 24-week, randomized, double-blind, placebo-controlled trials in more than 1,200 premenopausal women with HSDD.
Most patients used Vyleesi two or three times per month and no more than once a week. In these trials, about 25 percent of patients treated with Vyleesi had an increase in their sexual desire score, compared to about 17 percent of those who took a placebo.
About 35 percent of the patients treated with Vyleesi had a decrease of one or more in their distress score, compared to about 31 percent of those who took a placebo, the FDA said. Side effects during the trial included headaches, flushing and nausea.
Initial consumer uptake of Vyleesi is expected to be slow, according to industry analysts. But some expect revenue to increase significantly over time, hitting as much as $150 million by 2030, according to Barclays."
-RG
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