The libido enhancement drug flibanserin (Addyi trade name) took the stage last week after winning approval awaited from the US Food and Drug Administration (FDA ). Coverage of defenders and unbelievers has run the gamut advisory, caution, and critical likely to confuse undecided but-curious spectators. But exactly how Addyi battery until libido is still cloudy.
The drug has a long backstory. It was originally designed in 1995 by Franco Borsini pharmacologist and a team of researchers from Boehringer Ingelheim Italia in Milan as an antidepressant because of its ability to regulate chemical signaling molecules neurotransmitters-brain. In particular, the team suspects that the regulated drug three key neurotransmitters that can affect mood: serotonin, dopamine and norepinephrine. One clinical trial found that it did little to relieve depression, but a seem to have an effect on mood. It was not just the mood of researchers were expecting. These initial tests point to the greater role of clinicians flibanserin in sexual health, as female subjects had higher scores on the Arizona Sexual Experience Scale, a survey that asked participants to rate their satisfaction on a variety of sexual health topics, such as how often participants felt sexual desire and intensity of that desire was.
a separate group of researchers, also at Boehringer Ingelheim, completed their first clinical trials to explore flibanserin as libido enhancer in 08. They measured the levels of desire through a day- based assessment in which subjects recorded their levels of sexual desire on a daily basis. But the FDA concluded twice the resulting increases in libido are not statistically significant, and regulators are wary of potentially dangerous side effects such as dizziness, drowsiness, nausea and fainting.
So what became red green light from the FDA? For one: the test parameters. clinical investigator on the latest tests Addyi Sheryl Kingsberg explains that the evaluation of sexual desire in the brain are not a clear measure in particular. As the three clinical trials have increased in about 8 years, so have the techniques to determine the 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 Boehringer Ingelheim in 2011, and was in turn bought last week by Valeant Pharmaceuticals. The results of the last test, in 2014, focused on three parameters: sexual function index (where women responded to questions about the sexual experience and levels of sexual desire rated on a scale from one to five in the 28 days), satisfied sexual events, and distress felt from low libido. Overall, women have about a more positive sexual experience per month, and about 10% more of the patients who took Addyi reported significant improvements, according to a survey of these three categories, compared to a placebo group. By these measures, the FDA approved Addyi as the first drug for igniting desire.
Although it has been dubbed the "female Viagra," the two drugs work very differently, Viagra is designed to improve performance while Addyi aims to balance the chemicals in the brain that correlate with desire. Yet, researchers have only a rough idea of what drugs on the brain. Stephen Stahl, a psychologist at the University of California, San Diego, and Boehinger Ingelheim researchers wanted to clarify how it works on . chemical level in a 2011 document the Journal of sexual Medicine which examines previous studies its mechanisms, as they explain: Serotonin, which is thought to impede sexual interest, two types of receptors in the brain. 5-HT1A acts as brakes for the production of serotonin, 5-HT2A and speeds up production. Flibanserin works improving 5-HT1A (put on the brakes) and inhibition (stop acceleration) 5-HT2A . In between, serotonin production is strongly downregulated. Furthermore, downregulation of flibanserin serotonin decreases the firing of certain neurons thought to regulate the release of other neurotransmitters, namely dopamine and norepinephrine (both thought to improve sexual interest). The exact mechanism of these transient changes in neurotransmitter levels, however, is still largely unknown.
Stahl said that these same mechanisms likely to cause side effects that potential users-flibanserin concern effect on serotonin receptor called 5-HT1A probably causes dizziness and nausea, and its effects on the other, 5-HT2A, are probably related to drowsiness. Clinical trials have also shown that the combination of alcohol and flibanserin exacerbates these effects. Tests after the drug is on the market (scheduled for October) will look more closely at how alcohol actually interacts with the drug. For now, the FDA warned users against a black box warning.
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