Bloomberg the Company & Products

Bloomberg Anywhere Login

Bloomberg

Connecting decision makers to a dynamic network of information, people and ideas, Bloomberg quickly and accurately delivers business and financial information, news and insight around the world.

Company

Financial Products

Enterprise Products

Media

Customer Support

  • Americas

    +1 212 318 2000

  • Europe, Middle East, & Africa

    +44 20 7330 7500

  • Asia Pacific

    +65 6212 1000

Communications

Industry Products

Media Services

Follow Us

Hisamitsu Hot Flash Drug Fails to Win FDA Adviser Nod

March 4 (Bloomberg) -- 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.

To contact the reporters on this story: Meg Tirrell in New York at mtirrell@bloomberg.net; Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

Please upgrade your Browser

Your browser is out-of-date. Please download one of these excellent browsers:

Chrome, Firefox, Safari, Opera or Internet Explorer.