Most pharmaceutical companies understand how the FDA operates and are willing to wait for approval even though the process is a long one. FDA approval takes years, and even when a drug is approved for medical use it may only be approved to treat specific medical issues.
The German pharmaceutical company Boehringer Ingelheim began the process of Flibanserin FDA approval several years ago based on clinical tests conducted on over five thousand women around the world.
Flibanserin was originally developed to treat depression, but the first clinical tests showed that Flibanserin had the ability to increase sexual desires in women with hypoactive sexual desire disorder and sexual desire disorder, so Boehringer changed its marketing strategy and began clinical tests on women with different types of female sexual dysfunction (FSD).
Boehringer decided to seek Flibanserin FDA approval based on the results of four clinical tests on women who were experiencing a low libido or the inability to reach an orgasm during sexual activity. Women in the study were given 100mg of Flibanserin once a day for forty-eight weeks and the positive results of using Flibanserin are well documented.
Women in the study went from three sexual satisfying experiences per month to five a month. Flibanserin FDA approval is almost assured thanks to the successful results of the study, but Boehringer is still not sure when the Flibanserin will be available for sale.
Side Effects May Slow Down Flibanserin FDA Approval
The FDA is always concerned about the short term as well as the long term side effects of prescription drug use. The news is filled with stories about prescription drugs that are considered safe thanks to FDA approval, but are later banned for sale due to some side effect that didn’t show up in initial clinical tests.
Flibanserin FDA approval is imminent even though several short term side effects have been documented during the clinical studies.Headaches, insomnia, anxiety, dizziness, nausea, and fatigue are some of the prominent symptoms of Flibanserin use in clinical tests, but long term side effects are still an unknown.
Flibanserin contains dopamine D4 receptors and serotonin 5-HT receptors, so the company believes all the side effects have been identified.
Even though the side effects and the results of Flibanserin use are well documented no one is really sure how Flibanserin increases sexual desires. That fact may have an impact on Flibanserin FDA approval, but most people believe that will not be a factor in the agency’s decision.