Sentences with phrase «flibanserin in»

Not exact matches

The first trial was supposed to have been completed this month, but the FDA website lists it as pending, which means the study has not been initiated (type in «flibanserin» in the product box here).

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

Boehringer Ingelheim stepped away from flibanserin after the FDA rejected the drug due to concerns about its efficacy and safety; Goldstein persuaded the Whiteheads to step in.

Addyi (also known as flibanserin), developed by Sprout Pharmaceuticals, which was acquired by Valeant Pharmaceuticals (VRX) in August, hasn't been around all that long — the treatment debuted only last month — but still, its preliminary numbers don't bode well.

The drug, flibanserin or «Addyi», treats a condition called hypoactive sexual desire disorder (HSDD), which can cause chronic low desires to have sex in women.

Valeant Pharmaceuticals International Inc. said on Thursday it would buy Sprout Pharmaceuticals, whose drug flibanserin (Addyi) became the first approved treatment for low sexual desire in women, for about $ 1 billion with milestone payments.

Flibanserin targets two neurotransmitters in the brain that can help inspire sexual desire.

The FDA has twice rejected flibanserin, sometimes touted as a «female Viagra,» first when Boehringer Ingelheim pitched it in 2010 and then again in 2013 after tiny Sprout landed rights to the drug and then mounted its own campaign for an approval for hypoactive sexual desire disorder in premenopausal women.

In fact, flibanserin is a failed antidepressant: Patients who took it were no less depressed but noticed that their thoughts had turned lightly to love.

On August 18, the day arrived: Flibanserin — a failed antidepressant — received approval from the Food and Drug Administration to boost sexual desire in women.

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.

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.

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.

A drug called flibanserin, which was only approved by the US FDA (Federal Drug Administration) at the third attempt and is being marketed in the US in October 2015 under the name «Addyi,» produced similar results in clinical trials.

Although more trials are needed before flibanserin could become available commercially, it shows promise as the first drug demonstrated to treat low libido in women — the most common sexual problem in females — by targeting the brain.

«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.

Debates about the condition aside, Boehringer Ingelheim, the company that originally developed flibanserin, and Sprout, which acquired the drug in 2012, tested the drug in clinical trials in which 1,227 women diagnosed with HSDD received the now - approved 100 - milligram dose at bedtime.

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

Flibanserin, also known as pink Viagra, was approved by the FDA in late August.