I attended the recent annual meeting of the North American Menopause Society (NAMS) in Orlando, Florida and interviewed the author of a new study intended to gain approval for a new variant of an antidepressant drug, paroxetine. The purpose of the study was to identify a new non-hormonal treatment for hot flashes with lower dosages and less side effects than the existing paroxetine.
The new drug differs from the original one in that it has a slightly different chemical structure that allows it to be used in a lower dosage. It is technically called a low-dose mesylate salt of paroxetine, or LDMP. The intent was to prevent the frequently found side effects of the full dosage for which nausea, weight gain and reduced sexual function are common.
The study evaluated LDMP in approximately 500 women who had at least seven hot flashes daily and were very affected by their symptoms. Half of the women received LDMP and the other half received a placebo. The women were followed for 12 weeks for efficacy and for a total of 24 weeks for safety.
Paroxetine comes in dosages of 10mg, 20mg, 30mg and 40mg. In this study, a low-dose of 7.5 mg of the mesylate salt of paroxetine was able to statistically reduce hot flash both in frequency and severity compared to women who received a placebo.
The drug's impact began at one week and became statistically significant shortly after that. The benefits remained statistically significant at 4, 8, 12 and 24 weeks, which was the duration of the study.
There was a low frequency of side effects, and the most common was nausea, which occurred in 4% of the treatment group compared to 1% of the placebo group.
Hot flashes affect approximately 75% of women as they enter and pass through perimenopause and menopause. As millions of women know, hot flashes are very disruptive and affect the way they feel and sleep and the quality of their lives.
So naturally, women in menopause are looking for a safe and effective treatment for hot flashes. For now, the one approved and effective treatment is estrogen. Unfortunately, estrogen, also called estrogen therapy (ET), hormone therapy (HT) or in the past, hormone replacement therapy (HRT), comes with side effects and risks that make it an unacceptable or undesirable choice for many women.
LDMP is currently being evaluated at the FDA and hopefully will become an FDA approved non-hormonal alternative to treat hot flashes some time near the end of 2013. See my interview below with the lead investigator, Dr. Jim Simon.
WATCH: Dr. Jim Simon on LDMP and Hot Flashes