Hisamitsu Hot Flash Drug Fails to Win FDA Adviser NodMeg Tirrell and Anna Edney
Hisamitsu Pharmaceutical Co.’s experimental drug for hot flashes associated with menopause failed to win the support of U.S. regulatory advisers as an alternative to hormonal therapy.
The benefits of the medicine, paroxetine mesylate, in helping women avoid sudden sweating and feverish feelings linked to menopause don’t outweigh its risks of side effects such as suicidal thoughts, advisers to the Food and Drug Administration voted today. Earlier they voted against approval of another medicine for hot flashes, Depomed Inc.’s gabapentin.
Paroxetine mesylate is currently sold in the U.S. by Hisamitsu’s Noven Pharmaceuticals unit as Pexeva for depression, panic disorder and other conditions. Saga, Japan-based Hisamitsu bought Noven in 2009.
The FDA doesn’t have to follow its advisers’ recommendations. The agency is scheduled to decide on Newark, California-based Depomed’s drug by May 31 and Hisamitsu’s product by June 28.