The U.S. Food and Drug Administration has approved a new, non-hormonal medication for treating hot flashes and night sweats in women that was developed by Miami-based Noven Pharmaceuticals.
The medication, called Brisdelle, is the first non-hormonal treatment option for hot flashes and night sweats associated with menopause, the company said.
“Noven is proud to have developed Brisdelle, the first and only FDA-approved non-hormonal for the treatment of moderate to severe VMS [vasomotor symptoms], and to be the first company to offer both non-hormonal and hormonal treatment options for women,” said Jeffery F. Eisenberg, Noven’s president and CEO. The new medication should be available at U.S. pharmacies by November 2013, he added.
Many women are unable or unwilling to use hormone therapy to treat these symptoms, the company said, and now they will have a non-hormonal option. The new drug was clinically proven to reduce the frequency and severity of hot flashes and night sweats in trials that included 1,276 women, according to Noven. Brisdelle, which is paroxetine as a mesylate salt, will be available in 7.5 mg capsules.
Noven has been working on the new drug since 2007, when it took over another pharmaceutical firm where Brisdelle was in early stages of development.
The company, which is a relatively small player in the U.S. pharmaceutical sector, was competing with pharmaceutical giants in developing this non-hormonal treatment option and is the first to obtain FDA approval and bring the medication to market.
Noven is a specialty pharmaceutical company that does research and develops, manufactures and markets a range of products. It specializes in producing transdermal patches that release medicine after being applied to the skin. Noven is a unit of Japan-based Hisamitsu Pharmaceuticals and serves as the Japanese company’s growth platform for prescription pharmaceuticals in the U.S.