by PEhomepage.com Editorial Team
American men who eagerly await an FDA approved premature ejaculation pill will find no relief from the overseas approval of Priligy (dapoxetine). Priligy was rejected by the FDA years ago. It is estimated that the reasons behind the rejection of the file was related to the outrages belief that premature ejaculation is a lifestyle condition and not a disease, and therefore, a drug to treat it should be completely safe, something that cannot be reached.
An estimated
30 million adult men in the United States suffer from premature ejaculation, a condition thought to affect up to 15-30% of the male population worldwide. Health experts attribute lack of climax control to low levels of naturally produced brain chemical, serotonin. This important neurotransmitter is responsible for regulating mood and mental behaviors, promoting proper nervous system function and also helps prolong orgasm.
Priligy (dapoxetine) is among a class of selective serotonin reuptake inhibitor ( SSRI ) antidepressants drugs that are widely used to stimulate production of serotonin to last longer in bed. Side effects including nausea, headaches, diarrhea and dizziness are associated with SSRIs use leaving many men hesitant about using them to treat premature ejaculation. Priligy is the solution for these patients. With a short half life, and quick absorption, this drug could be used on an “as needed” basis, reducing the level of side effects and enabling patients to increase their latency time in bed. Based on the recent approval in Europe, it is expected that men all around the world (in China, India, Japan, Spain, France Italy, Germany, UK, Australia, Russia, Poland, Hong Kong, South Africa and Canada) will be able to use Priligy but not American men. This outcome is unreasonable and will necessitate a new discussion within the FDA to re-evaluate the approval of this important drug for a true unmet medical need.
Alternative treatments for PE are available and will have to remain the treatment of choice for American men until and if Priligy is approved. Available alternative treatments include, acupuncture, herbal creams, SS cream, spray, Chinese medicines, homeopathy and other multiple behavioral techniques. All are effective but cannot replace the need for a drug, heavily researched like Priligy to medically treat this disease.
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