Expert Interview with Lead Investigator for Dapoxetine ( Priligy ™ )by PEhomepage.com Editorial Team
Premature ejaculation ( PE ) is a condition that affects approximately 30% of men. Despite this high impact rate, there are no medications specifically designed to treat PE, although one medication is in the research phase. Researchers working with Johnson & Johnson to develop dapoxetine ( Priligy TM ), hope to gain approval, despite receiving a non-approvable letter in October 2005. The Food and Drug Administration indicated that additional research was needed to address questions with the medication before it could be approved.
John L. Pryor, MD, Professor and Chair, Department of Urologic Surgery, University of Minnesota Medical School in
Minneapolis,
Minnesota, has been working as a lead researcher on the team investigating dapoxetine’s efficacy in treating PE. He indicates that most men fail to seek treatment because of embarrassment. “They think that it is a sign of weakness. People don’t want to be underperformers in bed and oftentimes that’s how sufferers of premature ejaculation think of themselves, which is very sad. And so they do suffer in silence.”
The experimental dapoxetine ( Priligy ™ ), is a serotonin reuptake inhibitor ( SSRI ) with a short half-life, explained Pryor. “This is a very short half-life of 1.2 hours; you get peak plasma levels within 1 hour…So the bottom line is, it gets in quickly and gets out quickly.” The short half-life means that men could potentially take the medication on demand, rather than building up a specific level in the body as is the case with traditional SSRIs (such as Prozac®, Paxil® and Zoloft®). Dapoxetine ( Priligy ™ ), because of the short half-life, does not accumulate in the system and cause other side effects such as loss of libido.
One concern in the trial was the relatively high percentage of patients reporting nausea as an adverse side effect. According to the studies, approximately 20% of men complained of nausea as a side effect of the medication. Pryor commented that, “very, very few people had serious nausea.”
Other treatments for PE include topical ointments like lidocaine and the Korean product SS Cream. Pryor does not see that topical ointments will continue to be an option for treatment if dapoxetine ( Priligy ™ ), can be approved. “I think that when dapoxetine ( Priligy ™ ), comes out, it’s going to be like when sildenafil came out – all of those magical things that we had by and large disappeared. So no, I guess I don’t see a role for topical agents, which causes numbness in both the partner and the man.”
Behavioral interventions have dominated treatment of PE, primarily because most physicians view the condition as having a psychological etiology. Pryor, however, does not believe that the only cause of PE is psychological. He stated, “…for some people it may be a psychological issue and for many others clearly there’s a lot of evidence that it’s biological. We don’t have any great diagnostic criteria to say that this is what’s causing it with you vs. this is what’s causing it with another patient.” More study is needed in order to fully understand PE’s etiology. Behavioral interventions do not work with all individuals, and those who rely on it for treatment find that it is time intensive and expensive. It is also difficult to sustain any gains over long periods of time. Pryor also does not believe that for long-term change in PE patients that behavioral interventions are the treatment of choice.
There are additional lines of study for dapoxetine ( Priligy ™ ), that could include studying different dosages of the medication for varying degrees of ejaculatory latency time. For example, Pryor added, “Probably they should look more carefully at people who had premature ejaculation of less than a minute.” Pryor feels dapoxetine ( Priligy ™ ), has good potential to provide treatment options for men with premature ejaculation. “I think this is going to be a great thing for men with premature ejaculation.”
more: (
wikipedia.org/wiki/Dapoxetine
).
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