September 10, 2010. Major updated news:
Flibanserin will not be approved by the FDA for prescription use in the United States. After failing to prove that it's 100mg dosage was significantly more effective at increasing arousal or eliminating FSD and HSDD Flibanserin lost. Phase III clinical trials were looking okay but there were side effects and the government organization that makes or breaks it for big pharma made the decision to deliver the veto on Boehringer Ingelheim's Flibanserin product. That means there is only one product potentially set to be the female Viagra. LibiGel by BioSante is in Phase III clinical trials now. Will they make the grade? We'll have to wait and see.
The wait may be over soon
FDA panelist will gather in June to make decisions about an approval for Flibanserin. Going under potential trade names Girosa or Ectris the drug that hopes to make it big as the first potential treatment for HSDD may well have it's way into the market. Watch out for intense marketing soon if the approvals go through. Recent trial studies show women increasing their sexual encounters from 2.7 to 4.5 which may not be overly impressive but if you're adding any sexual activity while fighting a sexual disorder this may be great news to you!
Another contender for the first female Viagra
Flibanserin, or Girosa is a drug being researched and developed by German pharmaceutical company Boehringer Ingelheim. It has been in development for a few year and currently is under investigation and study as a treatment for women diagnosed with female sexual dysfunction (FSD) and (or) hypo sexual desire disorder (HSDD) or any post-menopausal decreases in sexual desire.
Being comprised of dopamine D4 receptors and 5-HT serotonin receptor agonist and antagonist it was originally being developed as an anti-depressant targeted towards a treatment for depression and mental instability and from reports was found to have positive impacts on sexual desire and arousal abilities. Being that there is absolutely no FDA approved drug for this area currently there seems to be more motivation for big pharma to develop a Viagra for women. Essentially, Flibanserin pills or tablets have been found to stimulate certain parts of the human brain which hold responsibility of releasing positive emotions, pleasure, and areas that control female sexual desire and sexual arousal.
Ironically Boehringer Ingelheim is not completely sure how the positive impact on sexual health occurs from Flibanserin but they are seeing positive results during all of their 4 clinical trials that have included over 5,000 women located in over 220 clinics worldwide. Just like BioSante is aiming to get LibiGel approved by the FDA in the next 18 months Boehringer is hoping to have an FDA approval for US medical use in 2009. Aiming at the Viagra market but for women it is easy to see how a billion dollar industry for men can have a trickle effect into the women's market being that scientists and doctors currently estimate 40% of all women in the US suffer from some symptom of FSD or HSDD.
How does an anti-depressant help with FSD?
There have actually been several reports of anti-depressants like Flibanserin having impact on sexual drive whether positive or negative. As we have seen time and time again it really depends on the situation and the specific condition of a woman. Sometimes FSD is a result of emotional distress, fatigue, or emotional disorders. In those cases drugs such as Flibanserin will look to be pretty successful as a treatment. In other cases where there are a combination of physical and emotional causes or simply physical conditions preventing pleasurable sexual activity they may not have as adverse an effect on women. Time will tell how effective this drug is as an overall.
Flibanserin clinical study reports and side effects
The most recent reported clinical trials were a 24 and 48 week double blind trial on hundreds of women are pretty interesting. The goals were to see positive impact on sexual desire and arousal over placebo in a noticeable difference and have so far been pretty promising according to reports. Most results appear to be occurring after 40 weeks so it is obvious that this is a long term therapy that will take time and commitment to recognize results when and if released. There have been some side effects from use of Flibanserin noticed as well though including:
- Urinary Infections
So for women increasing their pleasant sexual activities from 1 to 2 and 2 to 4 in a month these may be sided effects women will accept in order to improve their intimate life.
Buy Flibanserin or alternatives
Currently, there are absolutely no FDA approved treatments or therapies available including Flibanserin for medical use in the United States. The battle is on to complete FDA trials and get approval but until that time and probably more so after that time women will continue to look at all natural female libido enhancer products that are currently available on the market today. We will continue to research and provide the most current and best information possible on Flibanserin as it progresses and passes or fails FDA trials. This could get interesting.