Depomed abandons Sefelsa plans on FDA letter

Depomed stops investment in Sefelsa after FDA says it cannot approve menopause drug

Associated Press

NEWARK, Calif. (AP) -- Depomed Inc. said Friday that it will not invest further in its drug Sefelsa after the U.S. Food and Drug Administration said that it cannot approve its application in the current form.

The drug was designed to treat hot flashes and other symptoms of menopause. It hit a major road block in March when a panel of advisers to the FDA voted against the drug, saying the risks outweighed its benefits when used by menopausal women.

Depomed and other drugmakers have been experimenting with non-hormonal treatments for menopause, following studies showing that estrogen therapy could increase the risk of heart disease, stroke and breast cancer.

Known generically as gabapentin, Depomed's drug has long been used to treat pain and seizures. Doctors also prescribe the drug off-label, or without an FDA indication, to treat menopause symptoms. Newark, Calif.-based Depomed had asked the FDA to approve its version of the drug for that use, which would allow the company to explicitly market it directly to menopausal women.

However, panelists overwhelmingly recommended the FDA reject the use, pointing out that three company studies failed to show a significant reduction in hot flashes over 12 weeks. Patients also experienced side effects including dizziness, fatigue and balance problems. Gabapentin already carries a warning label that it can increase the frequency of suicidal thoughts.

The company said Friday that it got a complete response letter from the FDA to its new drug application that states that the FDA cannot approve the application in its present form. Based on the letter, Depomed said it does not currently intend to further invest in Sefelsa.

CEO Jim Schoeneck said the letter was expected after the panel report. He said the company is now focused on its two marketed drugs, Gralise and Zipsor, a strong balance sheet and the potential to turn cash flow positive in the second half of this year.

Depomed shares fell 3 cents to regular trading at $5.76 and slipped a penny in after-hours trading on the news.

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