At least that's what Shionogi Pharma is hoping. The Japanese drugmaker just released new data about its propellant spray and the findings suggest men will get a needed boost - those who sprayed the tip of their penis five minutes before having sex lasted 3-plus minutes compared with 34 seconds before the study began, and 56 seconds among the guys who were given a placebo. The results may not be huge, but every second counts.
The data actually combine two studies involving 1,092 men who were asked to have at least three sexual encounters and suffered premature ejaculation at least twice prior to the Shionogi experiment (see the press release). The International Society for Sexual Medicine defines PE as the inability to delay ejaculation for more than 1 minute after vaginal penetration and, supposedly, up to one-third of US men suffer.
Shionogi measured success two ways - the Intravaginal Ejaculatory Latency Time, as discussed above, and a patient survey that asked about distress, control and satisfaction. The men responded that PSD502 yielded improvement across the board, although so did the men on placebo, just not to the same extent. Side effects included 3.1 percent reporting loss of erection and 5 percent of the partners complaining of a burning sensation. Why that burning feeling? Ira Sharlip, a Shionogi consultant and clinical professor of urology at the University of California, San Francisco, posits that women "were having more intercourse than they usually have."
The spray, by the way, combines lidocaine and prilocaine, two local anesthetics, along with the propellant, atlhough Shionogi has no idea how it works. Nonetheless, Shionogi hopes to capitalize on a market that, like erectile dysfunction, is sure to generate substantial publicity and interest, especially since there is nothing currently available in the US for PE. Shionogi, in fact, worked overtime this past weekend at the American Urological Association to garner coverage of its data.
Nonetheless, the drugmaker can still expect some skepticism, despite the ISSM definition. "It would seem to be an entirely subjective measure, so that one man may say that it’s within 2 minutes and another may say that it’s within 10 minutes. How much is culturally determined?" says Joel Lexchin, a professor at York University's School of Health Policy & Management. "This strikes me as a bonanza for any company that can get a drug approved for this condition, since the company will try and set a standard time and any man that doesn’t meet that time is a potential user of the product."
11 Comments
*facepalm*
especially since there is nothing currently available in the US for PE
perhaps "no drug currently available" would be more accurate. I believe we covered non-drug options on a previous thread.
SSRI's work well for PE. Generic Paxil will be much cheaper than this product.
not to mention stuff some folks used to inhale.
It does not seem "mysterious" to me why spraying lidocaine on the front end might both extend its efficacy and sting its recipient.
As mentioned by pharmavet, one of the side effects of SSRIs (the likes of Paxil, Zoloft, Prozac etc) is delay or absence of ejaculation. Dapoxetine (Priligy) is one such (short acting) SSRI. It was owned and rejected for the depression indication by Eli Lilly, acquired by PPD tested for proof of concept and later on developed by J&J for PE. It was first approved in Feb 2009 in Sweden & Finland, then in Austria, Portugal and recently in Germany, Italy and Spain and submitted in other European countries, Canada, Australia, Mexico, Turkey and others countries. FDA has given a “non approvable” letter for the original submission, and do far no decision on it even after the extensive data from more trials. The European approvals seem to have triggered a lot of on line selling of the drug though. Even if the drugs (oral, spray which ever way) from J&J or Shionogi and others are approved, possibility of payments by the insurance for these lifestyle drugs would be worse than remote these days where the healthcare benefits trimmed even for the real diseases. They may be good if the people are willing to pay for them themselves.
Dr. Talluri, do you know what was the basis for FDA's rejection of dapoxetine? Seems to work ok in Europe.
SSRI's are more likely to cause sexual dysfunction in men. Not a very good recomendation folks, and lets not forget the increased risk for violence and suicide...
Increased risk of violence and suicide from antidepressants or from being male....?
FDA non approvable letter in 2005 was based on insufficient data on safety and efficacy. J&J later conducted 2 more trials and submitted the data to FDA. Though the PDUFA (Prescription Drug User Fee Act) date was second quarter of 2009, no word yet.
Thanks, Dr. Talluri. The resubmit should have triggered a 180 clock that should have expeired 4Q09 or 1Q10. J&J should have received word by now.
This is definitely a good news for men with the concern. Just wondering when they can make it available to the market. Thanks for your information!
Ed, the fact that this blog is almost one year old shows that the topic has "staying power".