(The author is a Reuters Breakingviews columnist. The opinions expressed are his own.)
By Robert Cyran
NEW YORK, Aug 19 (Reuters Breakingviews) - U.S. regulators approved the first pill for increasing sexual desire in women. The drug had been rejected twice because it's barely effective and carries severe adverse effects. The lesson for pharma firms: a public relations campaign successfully changed a watchdog's mind.
Full view will be published shortly.
- The U.S. Food and Drug Administration on Aug. 18 approved Addyi, a new drug developed by privately held Sprout Pharmaceuticals to increase sexual desire in pre-menopausal women.
- The drug was more effective than a placebo in about 10 percent of the patients who used it in clinical trials, increasing the number of sexually satisfying events by 0.5 to 1 additional times per month.
- The drug can cause severe low-blood pressure and fainting. The FDA mandated a "black box" warning - it's most severe - that patients should not use the drug when drinking alcohol or using certain medications such as birth-control pills. Doing so increased the risk of adverse effects.
- The FDA had rejected the drug twice before. An advocacy group called "Even the Score" which was associated with and funded by Sprout, lobbied for approval and urged women to write Congress in support of the drug.
- FDA statement http://1.usa.gov/1PyaCOZ
- Reuters: U.S. FDA approves 'female Viagra' with strong warning
- For previous columns by the author, Reuters customers can click on (Editing by Rob Cox and Carol Ryan; https://twitter.com/rob_cyran)
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