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An FDA labeling change could help to open up the market for Addyi, a drug designed to help fire up the female libido. Approved by the drug regulatory agency in 2015, the medication’s sales have been modest at best.
The marketers behind Addyi have faced an uphill climb even though the drug they’re selling would seem at first glance to be the answer to the dreams of women suffering from sexual dysfunction. Thanks to a recent labeling change, their job may be a bit easier in the future.
Addyi, designed to treat hypoactive sexual desire disorder, or HSDD, the most common form of female sexual dysfunction, was dubbed with the misleading nickname “female Viagra” long before it ever came to market.
Not at All Like Viagra
While the medication does offer premenopausal women a way to treat lackluster sexual desire, Addyi works in an altogether different fashion than Viagra and the other oral erectile dysfunction drugs known as PDE5 inhibitors.
Viagra and related medications work by temporarily improving blood flow to the penis to open up a window of time during which men with ED can get and keep an erection.
However, flibanserin, the active ingredient in Addyi, works on brain chemistry to depress brain levels of serotonin, a neurotransmitter associated with a decline in sexual desire. As serotonin levels drop, brain levels of dopamine and norepinephrine, substances linked to increased sexual desire, tend to rise, thus helping to fire up the libido.
Black-Box Warnings
After a long and contentious battle to win Food and Drug Administration approval for Addyi, Sprout Pharmaceuticals, the tiny drug company behind the drug, was saddled with FDA-mandated black-box warnings that advised users against any alcohol consumption while taking the drug.
Since the drug must be taken daily to achieve the desired results, that effectively meant that women using Addyi had to swear off alcohol use altogether.
Fortunately for Sprout, the FDA recently modified its warning to relax its ban on alcohol use while taking Addyi. The revised safety label now suggests that care should be taken to avoid alcohol consumption close in time to when Addyi is taken.
Could Broaden Drug’s Market
This should open up the market to women who enjoy a drink now and then but would still like to take advantage of a drug that could increase their desire for sex.
Sprout, headquartered in North Carolina, led the fight to win FDA approval for the drug, which finally came in August 2015. Within days of the FDA announcement, Sprout and its rights to Addyi were snapped up by Canadian-based Valeant Pharmaceuticals.
Addyi failed to take off as its backers hoped during the more than two years it was under the control of Valeant. Some blamed a less-than-inspired marketing campaign for the drug. In any case, Valeant sold Sprout and Addyi back to their original owners in late 2017.
Sexual Politics Invoked
As part of their current campaign to reach consumers, Addyi’s marketers have entered the battlefield of sexual politics by portraying sexual desire as a feminist right. The Addyi.com website offers a step-by-step guide for women who want to reclaim that sexual desire by using the drug.
This marketing strategy has come under fire from some women’s organizations, including the National Women’s Health Network. In an interview with Kaiser Health News, Cindy Pearson, executive director of the network, said it was upsetting to see Sprout “co-opt” some of the network’s language to sell a product of questionable value.
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Men suffering from ED may find that Viagra or one of the other PDE5 inhibitors can at least temporarily restore erectile function. If the convenience of ordering such drugs online appeals to you, check out eDrugstore.com, a longtime online facilitator. It supplies a full range of ED medications — both brand-name and generic. To learn more, visit its Erectile Dysfunction page.
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