Approval of Sprout Pharma’s Addyi (flibanserin 100 mg) in August 2015 was heralded by some groups as a new era in women’s sexual health. Addyi’s approval for treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women provided an oral, nonhormonal treatment option to address an issue that affects up to one-third of women. Women with HSDD experience low levels of sexual desire, and some of those women want to enjoy more frequent sexually satisfying experiences.
Although advocates considered the approval of Addyi (which was rejected twice previously by the FDA) a major win, there were challenging stipulations attached to this approval and significant questions surrounding safety and efficacy.
First, the FDA attached a Risk Evaluation and Mitigation Strategy (REMS) to Addyi, which requires healthcare providers and pharmacists to watch an online slide presentation and take a test before being able to prescribe or dispense it.
No alcohol allowed
In addition, the black box warning on Addyi’s label warns that drinking alcohol while taking Addyi increases the risk of severe hypotension and syncope and taking any drugs that are strong CYP3A4 inhibitors (such as clarithromycin and other commonly prescribed antibiotics) or cause hepatic impairment is also contraindicated.
Perhaps this is why as of mid-November, more than one month post-launch, only 227 prescriptions for Addyi had been written and only 1% of 35,000 OB-GYNs and 435,000 primary care physicians had become certified to prescribe Addyi, although it’s only a 10-minute process.
Intrepid Vogue journalist tries Addyi
Black box warning notwithstanding, there has been some consumer interest in Addyi. After all, before Addyi was approved, a survey conducted by the ‘big data’ analytics firm Treato showed that 80% of surveyed women would be willing to take a pill to increase sexual desire.
Much of the interest in Addyi has been expressed in women’s consumer publications. In fact, this month’s issue of Vogue—a women’s fashion and lifestyle magazine with a circulation of 1.2 million-plus readers—includes a feature article written by journalist Amy Gamerman about her experience taking Addyi.
Gamerman decided to take Addyi for a test run to see if she could rev up her “elusive” libido and regain the early headiness of her sex life with her husband of many years (and the father of her four children).
REMS in action
According to Gamerman, getting a prescription for Addyi was “maddenly difficult,” requiring several trips to New York’s Maze Women’s Sexual Health Center. Gamerman underwent a full medical work-up. In addition to having her blood pressure, hormone levels, kidney function and liver function checked, Gamerman also had to answer a series of questions about her relationship and overall psychological and physical health. Finally, when she had successfully completed the intake process, she could only procure Addyi through a specialty pharmacy in Pennsylvania.
Just as Gamerman was getting to the finish line, the pharmacist required that she sign a consent form agreeing not to drink alcohol and promising to lie down if she felt light-headed.
Gamerman conceded that although she had enjoyed sex pre-Addyi, it wasn’t earth-shattering or even something she craved. Sex was a take-it-or-leave-it situation—something that Gamerman hoped to change. In fact, before hearing about Addyi, Gamerman had sought help from a sex therapist and had also tried low-dose testosterone to increase her drive, but the effects were minimal.
For the most part, Gamerman took Addyi as recommended—one 100 mg pill each night before bed. Except one night, Gamerman broke a cardinal rule. About two weeks after starting Addyi, Gamerman and her husband had a date night and shared a bottle of red wine. She became very sleepy and lethargic and ended up going to bed as soon as she could.
Operation Addyi: Successful
The first couple of days of taking Addyi, Gamerman felt queasy, but that eventually resolved. She felt very little difference at first, but gradually Gamerman felt something happening. It was slow and subtle, but her drive was definitely increasing, according to her account. She wrote about feeling a ‘stirring’ and even starting to initiate sex with her husband.
Gamerman concluded that Addyi had helped her become more libidinous by creating a ‘good neurochemical environment’—an environment more conducive to sexual desire and satisfaction—in her brain. As a result, at the end of the initial 30-day treatment period, Gamerman called in a refill.
Gamerman got what she wanted out of Addyi—more and better sex. However, in her article, she did not discuss whether or not she was prepared to become a teetotaler or how the consideration of alcohol abstinence might affect her long-term adherence to Addyi.
The ideal Addyi target?
Regardless of Gamerman’s long-term relationship with Addyi, her test-run went well and she ended up sharing her positive experience with 1.24 million Vogue readers. This, in and of itself, is a powerful form of DTC communication, though it was not sponsored by Sprout or any other pharmaceutical company.
The average Vogue reader is 38-years-old, with a median household income of $62,000 and an avid interest in fashion, lifestyle, culture, and overall well-being, according to publisher Conde Nast. In short, Vogue’s readership is an ideal target for a drug like Addyi, which has an aspirational quality that appeals to certain women.
A marketing challenge
Being able to communicate the potential libido-enhancing, neurochemical benefits of Addyi, while also providing the necessary fair balance regarding adverse events, is a creative challenge that requires the prowess of good medical marketers.
Admittedly, while Addyi’s approval was celebrated in some quarters, it was met with cynicism by many critics who consider Addyi’s benefits negligible compared with its risks. Nonetheless, Addyi will undoubtedly work for some women and be worth the effort. Gamerman’s experience provides important insights into who might benefit from the treatment, and could be an excellent starting point for developing a DTC campaign.