It’s very important when you see news headlines that you read between the lines.
This came across my mailbox earlier in the week:
Noven Receives FDA Approval for Brisdelle™ (Paroxetine) Capsules, the First Nonhormonal Therapy for Vasomotor Symptoms Associated with Menopause
So, let me explain.
Brisdelle is the first non-hormonal treatment for menopause to receive FDA approval. But, it’s not the first nor the only nonhormonal treatment for vasomotor symptoms; heck, one glance at the tag cloud or the archives and you will see that there are lots.
Claim aside, it’s important to break down the news for you.
Brisdelle is a low-dose form of Paxil, an SSRI antidepressant. Because of its dosage, it is only indicated for treatment of hot flashes and night sweats, and not for depression, obsessive compulsive disorder and anxiety.
This is what I wrote late last year when Noven first presented study findings to the North American Menopause Society:
Paroxetine is not the first antidepressant to be studied in menopausal women and you may recall that I wrote about the use of Lexapro for hot flashes about two years ago. You can find that post here. However, paroxetine is the antidepressant that’s all the buzz right now, since Noven Pharmaceuticals presented two studies last week at the North American Menopause Society annual meeting. Note that it’s been reframed as ‘low-dose non-hormonal therapy for menopausal vasomotor symptoms,’ but ya still gotta call a spade a spade and what it is is an antidepressant.
In one of two studies, 568 women (40+ years of age) who experienced 7 to 8 moderate or severe hot flashes on a daily basis of 50 to 60 on a weekly basis took either 7.5 mg of LDMP or placebo daily over six months. By the end of the first month (and in contrast to the study’s start), women who were taking LDMP experienced 28.9 fewer hot flashes per week (compared to 19 fewer per week for women taking placebo pills). By the third month, this increased by roughly 10 fewer per week in both groups. The severity of the hot flashes also significantly decreased. Safety wise, women taking LDMP reported nausea and bronchitis.
In the complementary study, which lasted for three months, 606 women in the same demographic took the same dose of LDMP or placebo. Decreases in mean number of flashes per week were pretty much on par with the first study (33 compared to 23.5 for placebo) and similarly, a trend towards maintaining and growing benefits were observed. Severity of hot flashes also declined but by the study’s end, were not significantly different than placebo. This time, women who took LDMP most frequently reported dizziness and fatigue.
Dr. James Simon, one of the studies’ investigators and a professor of ob/gyn at GWU School of Medicine claims that symptoms of menopause often go untreated when women are unable or unwilling to take hormone therapy, which is not entirely true. Another investigator — Dr. Andrew Kaunitz from the University of Florida College of Medicine in Jacksonville notes that if LDMP is approved by the FDA, “it could be the first nonhormonal option available for women.” Again, this statement is not entirely true. LDMP has the potential to become the first nonhormonal treatment APPROVED by FDA for vasomotor symptoms in menopausal women. There are other options out there but on the most part, they are not embraced by Western practitioners. Take note: while many Western practitioners will argue until they are blue in the face that alternative strategies have no role, are no better than placebo, and do not have evidenced-based trial data to support their use, they are simply incorrect. An unequivocal statement about every alternative strategy available to wo-man is bad medicine at best and at worst? Sheer ignorance.
Back to LDMP…LDMP appears to effectively diminish hot flashes and sweats but it is not without side effects. And while the dosage is considerably lower than full-strength antidepressants, we don’t have enough information to know if it will ultimately mimic its higher dose partner; the most common side effects reported in these trials are the very same that have been reported with Paxil. Another common side effect of Paxil is the effects on libido and it is a well known fact that as many women go through menopause, they experience declines in sex drive, lubrication and the ability to reach orgasm. In the pivotal studies used to gain approval, about half of the women appeared to have sexual dysfunction; what’s unclear is whether or not the cause was the drug or menopause itself. Another important point that is missing from this story is that back in March, the FDA’s advisory committee on reproductive drugs voted against approval, stating that paroxetine’s effectiveness in reducing hot flashes was underwhelming and not unlike that seen among women taking placebo in clinical studies.
I applaud Noven for its efforts to offer an alternative to HRT, one that has been approved by the FDA. However, the way that communications about this agent are being framed, it appears that the spin masters are working overtime. It’s essential to understand that this treatment is non-hormonal but still a pharmaceutical agent. And while I am a huge proponent of antidepressants for depression, I remain skeptical that they are the best agents for addressing menopausal symptoms. Cost may be an issue – no word on the price point as of yet.
I guess that time will tell.