Project name: ospemifene
Disease: Dyspareunia (painful intercourse)
Peak sales estimate: $495 million
Approved: Feb. 26
Companies: Shionogi and QuatRx Pharmaceuticals
As many as 32 million postmenopausal women in the U.S. suffer from dyspareunia, or painful intercourse, a symptom of vulvar and vaginal atrophy (VVA) due to declining levels of estrogen hormones. But legions of women and their providers avoid proactively seeking treatment or discussing symptoms, experts have noted. That's where Japan's Shionogi hopes to swoop in with a promising, first-of-its-kind treatment that won FDA approval in late February.
Shionogi believes Osphena is a vital improvement to the standard of care for VVA and touts it as the first-ever oral alternative in the U.S. market to estrogen-based suppositories or lubricants used to treat VVA. As the FDA explained at the time of approval, the drug essentially acts like estrogen on vaginal tissues and helps make them less fragile. Once that happens, the treatment reduces pain during sexual intercourse. It is taken orally once daily.
In addition to providing a new treatment, Shionogi also sees an opportunity to boost sales by destigmatizing a condition that affects millions of women. To that end, the company launched a consumer website--findingthewords.com--to promote Osphena. Narrated by actress Virginia Madsen, the website uses a number of articles and information links to encourage women to "break the silence" and find help.
A Jefferies analyst told Bloomberg at the time of approval that the drug stands to grow substantially and generate as much as $495 million in sales by 2017. Shionogi licensed Osphena from QuatRx Pharmaceuticals in 2010 for $25 million upfront and $100 million in milestone payments, so the potential return on investment is noteworthy.
In the FDA's approval, regulators noted that Shionogi proved the drug's safety and effectiveness in three clinical studies involving 1,889 postmenopausal women. According to regulators, the first two trials showed a major improvement in women treated with Osphena versus a placebo. A third study pointed well toward the drug's long-term safety risks.
As the population ages, Osphena stands to gain tremendously in the coming years, but that same expected jump in older patients over time means that competition is coming. In October, Pfizer ($PFE) and Ligand ($LGND) snagged FDA approval for Duavee, formerly known as Aprela, which combines estrogen conjugates with the antagonist bazedoxifene to treat moderate-to-severe hot flashes in menopausal women who haven't had a hysterectomy.
Still, obstacles might crop up with long-term use. Estrogen treatments can boost the risk of endometrial cancer, and Osphena acts like estrogen on vaginal tissues. The FDA mandated a boxed warning alerting that the drug carried a risk of endometrial cancer or conditions leading to it. As a result, regulators warned that Osphena should be used for "the shortest duration consistent with treatment goals and risks for the individual woman." -- Mark Hollmer (email | Twitter)
Pfizer, Ligand snag FDA approval for hot flash drug
Shionogi wins FDA approval on Osphena for painful sex