Tags: FDA | Depomed | Menopause | Drug

FDA Advisers Vote Against Depomed Menopause Drug

Monday, 04 Mar 2013 03:39 PM

Advisers to the U.S. Food and Drug Administration on Monday recommended the agency reject a drug made by Depomed Inc to reduce the frequency and severity of hot flashes associated with menopause.

The vote sent shares of Depomed down 10 percent to $5.85 in afternoon trading Mondayon the Nasdaq. They fell as low as $5.12 immediately after the shares resumed trading following a halt pending the results of the panel.

The panel of advisers voted 13-1 that the company had failed to prove convincingly that the drug worked. They voted 12-2 that its efficacy, when balanced against risk, did not warrant approval.

The drug, Sefelsa, is a long-acting version of the epilepsy drug gabapentin. A short-acting version of gabapentin made by Pfizer Inc and marketed as Neurontin was approved in 1993.

Clinical trials of Depomed's drug showed it only partially reduced the frequency and severity of hot flashes, while side effects included dizziness, sleepiness, headache and nausea. Gabapentin has also been shown to increase the risk of suicide.

The FDA does not have to follow the recommendations of its advisory panels but it generally does.

Depomed said it would cease spending on Sefelsa.

"We recognize and appreciate the concerns that were raised by the members of the Advisory Committee," Jim Schoeneck, Depomed's chief executive officer, said in a statement. "Based on today's meeting we believe the hurdles for approval of a non-hormonal treatment for hot flashes remain high."

Depomed's drug was approved in the United States in 2011 to treat shingles-related pain and is marketed under the brand Gralise.

Sefelsa is one of two non-hormonal drugs designed to reduce hot flashes being considered on Monday. The second is a drug from Noven Pharmaceuticals Inc, a unit of Hisamitsu Pharmaceutical Co Inc, that comprises a low-dose version of the antidepressant paroxetine mesylate.

Noven sells a higher dose of the drug under the brand Pexeva for, among other things, depression, obsessive compulsive disorder and generalized anxiety. A similar drug, Paxil, is made by GlaxoSmithKline Plc.

Hot flashes affect some 75 percent of the estimated 32 million women in the United States experiencing menopause each year, Depomed said. Hot flashes, characterized by warmth, flushing and sweating, can be disruptive and can last anywhere from a few years to more than a decade.

Diana Zuckerman, president of the National Research Center for Women & Families, a nonprofit organization that promotes health and safety of children and adults, said the FDA should reject Noven's drug also.

"Although it has a little more evidence of effectiveness than gabapentin, the very small benefit is outweighed by the very substantial, well-known risks," she said.

"People are willing to take those risks for an effective anti-depressant, because depression is so debilitating. However, those risks are much too high for a drug that is not very effective at reducing hot flashes."

Risks associated with paroxetine include an increase in suicidal thinking.

© 2017 Thomson/Reuters. All rights reserved.

   
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Advisers to the U.S. Food and Drug Administration on Monday recommended the agency reject a drug made by Depomed Inc. to reduce the frequency and severity of hot flashes associated with menopause.
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2013-39-04
Monday, 04 Mar 2013 03:39 PM
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