Pfizer, Ligand get FDA nod for hot flash drug Duavee

Pfizer and partner ($PFE) Ligand Pharmaceuticals ($LGND) have gotten a new drug approved to treat hot flashes in some women with menopause. It's a potentially receptive market but one that has been made skittish by a decade of concerns over the ties between older hormone treatments and breast cancer.

The FDA Thursday gave the OK to Duavee for moderate-to-severe hot flashes related to menopause in women who haven't had a hysterectomy. It also was approved for prevention of postmenopausal osteoporosis. The FDA pointed out it is the first product that combines estrogen with estrogen agonist/antagonist bazedoxifene, which reduces the risk of endometrial hyperplasia.

"We know that many women currently experiencing menopausal symptoms are not receiving treatment and have not talked to their doctor about hormone therapy," said Dr. Gail Cawkwell, vice president of Pfizer medical affairs. "It is clear that the menopause dialogue needs to improve."

That dialogue fell off for obvious reasons. Hormonal treatments used to be commonplace, but their popularity dwindled more than a decade ago after a large study tied them to an increased risk of breast cancer. Pfizer and other drugmakers have spent years defending or settling litigation over potential risks from earlier drugs, like its Prempro and Premarin. According to Bloomberg, Premarin still generated $1 billion in sales last year. Evista from Eli Lilly & Co. ($LLY), which was approved in 1997 for prevention of post-menopausal osteoporosis, generated $1 billion in sales last year as well, Bloomberg said.

Duavee comes into the market four months after the FDA approved the first non-hormonal treatment for hot flashes. The drug is Brisdelle from Noven Therapeutics, a unit of Hisamitsu Pharmaceutical. While Brisdelle does not contain hormones, it does contain, paroxetine, the same ingredient found in the popular antidepressant and anti-anxiety drug Paxil. Paroxetine carries a boxed warning about the risk of suicide associated with its use in children and young adults.

- here's the FDA release
- see Pfizer's announcement

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