Sentences with phrase «of flibanserin»

Jaspers said their findings suggest the FDA should reconsider its approval of flibanserin but cautioned that the agency may have taken other factors into account to make its decision.

The findings «suggest that the benefits of flibanserin are marginal,» given that «one in three women experience side effects, of which the most common ones include dizziness, sleepiness, nausea, and tiredness,» said lead author Dr. Loes Jaspers, of Erasmus University Medical Center in Rotterdam, the Netherlands.

Not exact matches

Sprout resubmitted flibanserin to the FDA in early 2013, filing roughly 700,000 pages of data.

Addyi, known to scientists as flibanserin, is thought to work by changing the balance of certain brain neurotransmitters like dopamine and serotonin.

Flibanserin was approved by the FDA on its third attempt, but the agency's clinical reviewers recommended that it be rejected, wrote Drs. Steven Woloshin and Lisa Schwartz, of The Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, New Hampshire, in an editorial.

A separate group of researchers, also at Boehringer Ingelheim, completed their first clinical trials to explore flibanserin as a libido - enhancer in 2008.

As the three clinical trials progressed over the course of about 8 years, so did techniques in determining desire, says Kingsberg, a reproductive biology and psychology researcher at University Hospitals Case Medical Center in Cleveland, Ohio, and consultant to Sprout Pharmaceuticals, which bought flibanserin from Boehringer Ingelheim in 2011, and was in turn purchased last week by Valeant Pharmaceuticals.

These early trials tipped clinicians to flibanserin's more prominent role in sexual health, as female subjects had higher scores on the Arizona Sexual Experience Scale, a survey that asks participants to rate their satisfaction on a variety of sexual health topics, like how often participants felt sexual desire and how intense that desire was.

«I believe if flibanserin is going to play a role in sexual dysfunction for women, it's going to be part of a complex approach to addressing the women's sexual health issues,» Jayne says.

The studies (though conducted almost entirely in men) showed that there's a definite interaction between flibanserin and alcohol, with an increased number of side effects such as dizziness and fainting at moderate and high alcohol doses.

In August, the Food and Drug Administration approved Addyi (flibanserin) for the treatment of low sexual desire in women.

says John Thorp, an obstetrician and gynecologist at the University of North Carolina, Chapel Hill, who led the DAISY clinical trial for flibanserin, published in 2012 in the Journal of Sexual Medicine.

Many of these patients are naturally curious about flibanserin, or Addyi — the little pink pill that received FDA approval last year.

The drug will also contain a «boxed warning» that highlights the risk of severe low blood pressure and loss of continuousness among patients who drink alcohol and take flibanserin and other at - risk patients.