Hot Flash? Do Menopausal Women Really Need The Noven Drug?

Talk about hot flashes. Late last week, the FDA approved the first treatment for hot flashes associated with menopause that does not contain a hormone (see this and this). But the drug does contain paroxetine, which is the chemical name for the Paxil antidepressant. And this raises a question - can Noven Pharmaceutical successfully capture the attention of physicians and insurers? For one thing, the approval was a surprise. Last March, an FDA advisory panel voted 10-to-4 against recommending approval because the benefits of the drug, which is called Brisdelle, did not seem to sufficiently outweigh the risks. Of course, the agency can ignore recommendations from its committees, but such decisions are not made all that often. The FDA panel, though, was concerned because Paxil is one of several antidepressants that have a so-called Black Box warning about suicidal thoughts. The panelists were also unconvinced that a reduction in the frequency of hot flashes that were demonstrated in two studies, while statistically significant, would not be clinically meaningful (read here). Not surprisingly, the approval bolstered shares in Hisamitsu Pharmaceutical, which rose some 6 percent on the news; Hisamitsu is the parent of Noven Pharmaceuticals. The investor reaction reflected a few simple facts - hot flashes associated with menopause occur in up to 75 percent of women and can last up to five years. Moreover, many women do not seek treatment. This is because hormone-based therapy fell o...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs