The Food and Drug Administration (FDA) has approved flibanserin, a drug aimed at increasing women’s sexual desire, under the brand name Addyi. This decision follows a prolonged lobbying campaign by the drug’s makers and comes with numerous restrictions to mitigate concerns over its side effects.
Key Takeaways
- Drug Name: Flibanserin (Brand name: Addyi)
- Purpose: Increase women’s sexual desire
- Restrictions: Special training for doctors and pharmacists, strong alcohol warning, and limited prescription rights
- Side Effects: Risk of sudden fainting, especially dangerous for drivers
- Approval History: Previously rejected twice by the FDA
Approval and Restrictions
The FDA’s approval of Addyi is accompanied by stringent measures. Only specially trained physicians can prescribe the drug, and pharmacists must also undergo specific training. The FDA mandates a strong warning against alcohol consumption while taking Addyi due to the risk of sudden fainting, which poses a particular danger for drivers.
Background and Controversy
Flibanserin’s journey to approval has been fraught with controversy. Initially developed by Boehringer Ingelheim, the rights were later acquired by Sprout Pharmaceuticals. The company launched a public relations campaign, "Even the Score," arguing that while men have multiple sexual dysfunction drugs, women had none. Despite the campaign, critics argue that Addyi’s benefits are modest and its side effects significant.
Expert Opinions
Dr. Susan Wood, a former FDA official, expressed disappointment over the approval, citing the drug’s limited effectiveness and safety concerns. Dr. Philip Hanno, a urologist who voted against the drug’s approval, believes the FDA was pressured into its decision. Both experts highlight that the approval sets a precedent for treating drugs for women’s sexual health differently.
How Addyi Works
Unlike Viagra, which increases blood flow to help men achieve an erection, Addyi works by modifying serotonin levels in the brain. This chemical alteration is believed to enhance a woman’s ability to become sexually aroused over time. However, it is not an aphrodisiac and will not help women whose low sexual desire is due to relationship issues or other external factors.
Real-Life Impact
Katherine Campbell, a 31-year-old woman from Indianapolis, believes she could benefit from Addyi. After the birth of her first son, she noticed a significant drop in her sexual desire, affecting her relationship and self-confidence. For women like Campbell, Addyi offers a potential solution to hypoactive sexual desire disorder (HSDD).
Clinical Studies and Market Availability
Clinical studies indicate that Addyi can increase the number of satisfying sexual events by half to one additional event per month compared to a placebo. Sprout Pharmaceuticals plans to price Addyi similarly to Viagra, with an expected co-pay of $30 to $75. The drug is anticipated to be available by October.
Conclusion
The FDA’s approval of Addyi marks a significant milestone in women’s sexual health, despite the controversy and stringent restrictions. For many women, it offers a new treatment option for HSDD, although its effectiveness and safety continue to be debated by experts.
