FDA Panel Votes Against Approval of High-Risk Menopause Drug, Noven

The U.S. Food and Drug Administration recommended that the drug, Noven, a treatment used to manage hot flashes associated with menopause, be taken off the market.  

The drug, made by subsidiary of Japan-based Hisamitsu Pharmaceutical Co., Inc.  a panel voted 10-4 against its approval, according to Reuters, with the majority suggesting that the drug's benefit was not sufficient to offset its risks. According to Reuters, the panel was even divided over overall effectiveness.

The panel also stated the following:

Based on pre-specified analyses, there is sufficient evidence to conclude that the drug may be effective in treating moderate to severe VMS associated with menopause; and 10 to 4 that the overall risk/benefit profile of low-dose mesylate salt of paroxetine (LDMP; 7.5 mg/day) is not acceptable to support approval. Additionally, the committee voted 7 to 7 that, based on pre-specified analyses, there is sufficient evidence to conclude that LDMP is effective in treating moderate to severe VMS associated with menopause; and 10 to 4 that, based on pre-specified analyses, there is not sufficient evidence to conclude that the change from baseline in VMS frequency is clinically meaningful to women. The FDA is not bound by the recommendations of its advisory committees, but will consider their guidance during the ongoing review of NDA that was submitted for LDMP in August 2012. 

"As conveyed during Noven's presentation, we believe our clinical trial data support LDMP as a safe, effective nonhormonal treatment option offering clinical benefit to menopausal women," said Joel S. Lippman, M.D., Noven's Executive Vice President - Product Development and Chief Medical Officer. "While we are disappointed in today's outcome, we appreciate the discussion and will work closely with the FDA as it completes its ongoing evaluation."

*This story has been updated to note a correction.