FDA Panel Nixes 2 Nonhormonal Meds for Hot Flashes
Later in the day, the panel voted 10-4 against low-dose Pexeva, saying the drug's minimal benefit did not outweigh its risks.
A few concerns also were raised about the drug's safety profile, and in particular its association with suicidal thoughts and osteoporosis.
Julia V. Johnson, MD, from the University of Massachusetts Medical School in Worcester, who was chairperson of the day's committee meeting, says she felt those risks were small and did not appear to be different from the risks seen with more standard doses of paroxetine. "Still, we have very little information about this lower dose. We did see some effect on suicidal ideation, and I was somewhat concerned that there may be a greater effect than seen."
A bigger stumbling block for the panel was the relatively small benefit seen with Pexeva compared with a placebo. "I voted against recommending approval when I looked at the magnitude of the treatment effect relative to the magnitude of the placebo effect, where there is no risk involved," says Daniel L. Gillen, PhD, from the University of California, Irvine.
However, some panel members believe they saw some evidence of benefit with the drug.
"I'm not worried about the safety profile, because it's already an FDA-approved drug. If we are worried, the way to address that is to help women access a lower-dose version," says Eleanor Bimla Schwarz, MD, from the University of Pittsburgh School of Medicine in Pennsylvania.
Richard Bockman, MD, PhD, from the Hospital for Special Surgery in New York City, says it is time to approve this drug because it is already being commonly used off-label to treat hot flashes.
"I think there is a very small beneficial effect from this drug," he says, explaining his yes vote. "It is widely used and there is wide experience with this drug. This very small dose is probably safe. I think it's time to legitimize its use."
Clifford J. Rosen, MD, from Maine Medical Center Research Institute in Scarborough, voted against recommending approval but says he empathizes with the yes voters.
"In some ways, having an indication might allow us to have better surveillance over who is getting this drug and how it is being utilized. Right now, we have very strong difficulty figuring this out," he says.