Endoceutics should have a U.S. distribution partner for Intrarosa, a newly FDA-approved treatment for vulvovaginal atrophy in postmenopausal women, before the end of the year, says founder and CEO Fernand Labrie.
In an interview with FiercePharmaMarketing, Labrie said his company is in discussions with a “few” pharma companies to sell Intrarosa in the U.S. and expects a deal to close soon. He is hopeful that the treatment will get to market in the U.S. during the first part of 2017. Endoceutics, based in Quebec, Canada, is also in discussions with partners to distribute Intrarosa in Europe and in its home country.
Intrarosa is a nonestrogen solution, and the first FDA-approved product containing prasterone, also known as DHEA. It is a daily vaginal insert that the FDA approved two weeks ago to treat moderate to severe pain during sexual intercourse, caused by vulvovaginal atrophy. Painful sex is the one of the most frequent complaints of postmenopausal women suffering from VVA, which also can cause vaginal dryness and itching.
Estrogen replacement therapies had been the most common treatment, but those hormone therapy solutions have come under scrutiny with increased evidence of potential significant side effects for some women. That means that “long-term systemic hormone therapy for the prevention of postmenopausal conditions is no longer routinely recommended,” according to the Mayo Clinic.
“Today in the U.S. 32 million women have vaginal atrophy, but only about one million are treated—about 3%. Mostly because of the fear of (the side effects of) estrogen,” Labrie said.
Local estrogen treatments like Pfizer’s Estring have sprung up in the wake of the slowdown in systemic hormone therapy recommendations, while Shionigi’s Osphena works as an estrogen antagonist also meant to treat painful sex after menopause caused by VVA. Both drugs have launched marketing and advertising campaigns to talk about the sensitive subject.
While Endoceutics will likely leave the advertising to its new partner, Labrie said he wants to continue to be involved with Intrarosa.
“We want to remain involved as possible and provide as much support as possible,” he said, adding, “It’s a new paradigm of menopause.”