When is alprostadil topical cream coming to America … if ever?

For men with mild to moderate erectile dysfunction after treatment for prostate cancer,  and especially for those who don’t respond well to the phosphodiesterase inhibitors like sidenafil (Viagra) and taldalafil (Cialis), simple treatment options are very limited. Indeed, it basically comes down to the use of vacuum erection devices (VEDs); penile injections of Bi-Mix (papaverine + phentolamine), Tri-Mix (papaverine + phentolamine + prostaglandin), or alprostadil; or a penile implant.

For many men, however, intracavernosal injections and VEDs are either painful or just emotionally unpalatable for one reason or another.

There are approved formulations of topical alprostadil creams available in some parts of the world. One is a product variously known as Befar or Vitaros (a formulation of alprostadil combined with the manufacturer’s patented “NexACT transdermal penetration enhancing technology”). This cream has now been approved in China, Canada, and the European Union.

Data are to be presented today (at an International Symposium on Prostate, Androgens and Men’s Sexual Health, in Berlin, Germany, by Dr. John P. Mulhall of the Male Sexual and Reproductive Medicine Program at Memorial Sloan-Kettering Cancer Center) from two Phase III clinical trials of this drug — used short-term and long-term — in the treatment of erectile dysfunction.

However, we should be clear that the original data demonstrating the efficacy and safety of this topical formulation of alprostadil were presented in December 2011, so it is not clear to us what the problem is about bringing this drug to market here in the USA.

According to a media release from Apricus Biosciences (issued earlier today), the new data being presented today show that:

  • In short-term use for 12 weeks in 1,727 patients
    • Men treated with Vitaros had a significant improvement in erectile function (EF) score of up to 51 percent compare to men treated with a placebo.
    • Men treated with placebo had a change in EF score of – 0.7.
    • Men treated with 100 μg of Vitaros had a change in EF score of + 1.6.
    • Men treated with 200 μg of Vitaros had a change in EF score of + 2.5.
    • Men treated with 300 μg of Vitaros had a change in EF score of + 2.4.
  • In longer-term use (involving 1,161 patients)
    • 100 percent of men treated with 100 μg of Vitaros reported improvement in their erections.
    • 100 percent of men treated with 200 μg of Vitaros reported improvement in their erections.
    • 88.2 percent of men treated with 300 μg of Vitaros reported improvement in their erections.
    • Compared to the end of the 12-week treatment, the mean IIEF score continued to improve for men choosing the 300 μg dose level.
    • There was no indication that the efficacy of Vitaros diminished with longer-term use.
  • The majority of adverse events were transient, and mild or moderate in intensity.
  • The incidence of reports of adverse events decreased with repeated exposure to the drug.

According to the company web site, an application to the U.S. Food and Drug Administration to market Vitaros in the USA is “pending”, so it is unclear when or if this drug will be approved for clinical use in the USA.

We should also note that we know of no data testing this drug specifically in men with erectile dysfunction directly related to their prostate cancer treatment. Having said that, there is little doubt that, for those men who do not benefit from the phosphodiesterase inhibitors, and for whom intracavernosal injections and VEDs are not acceptable options, a simple cream does potentially offer a whole new opportunity (always assuming that it is both effective and safe in men who have been treated for prostate cancer).

15 Responses

  1. Gee, I wonder if the makers of Viagra and Cialis might be blocking their application.

  2. Oh yeah, where can I get some now?

  3. It is not actually possible for other manufacturers to “block” an application in the manner you are suggesting … and I suppose it may be possible to get some if you go to Canada (if you live in the USA).

  4. If it’s not those profiting off the current situation in the US using political and financial pressure to continue blocking access to a superior drug, then what’s the problem?

    Seems pretty naive to think there’s a reason other than short-term greed keeping millions of men from safe, effective treatment.

  5. Who says it’s a “superior” drug? It’s just different. It is perfectly possible that the company just hasn’t filed the data with the FDA here in the USA.

  6. The last three bullets in your description suggest it’s a superior drug to what’s available to men in the US. And, as a topical, by definition is less invasive than currently available delivery mechanisms like needles in the penis, systemic therapy, major surgery, and/or mechanical devices.

  7. ◦ 100 percent of men treated with 100 μg of Vitaros reported improvement in their erections.
    ◦ 100 percent of men treated with 200 μg of Vitaros reported improvement in their erections.

    If it is 100% effective then it is definitely a superior drug!

    Somebody is in collusion with someone to stop this from getting to market and it stinks, pure and simple.

  8. Dear GW and Tracy:

    (1) These are data from a media release from an interested party for Heaven’s sake. Do you believe all the ads you see on the television too? I’ll believe the peer-reviewed, published data when I see it. How are they defining “an improvement” in the patients’ erections? That could mean anything.

    (2) There is still no evidence of any sort of conspiracy! It’s up to the manufacturer to submit appropriate data to the FDA if they want to get this drug approved. Companies fail to do this appropriately all the time!

  9. If this product has been approved by Health Canada then what is reason that it is not available in Canada?

  10. Dear Virendra:

    I am no expert on the availability of specific drugs in Canada. However, I do know that just because Health Canada approves a product for marketing and prescription does not necessarily mean that individual Canadian provinces are willing to cover the cost.

  11. Sterile compounding pharmacies have been making this for years. … I know because I have made it. Ask your urologist to write a prescription and train you.

  12. Since the Vitrose is approved by Health Canada, then approval from FDA is necessary for marketing in Canada? Why patients have to wait for FDA approval who are dragging their feet since level III testing is complete now.

  13. Dear Vijay:

    If Health Canada has approved this product for use in Canada, there is absolutely no requirement whatsoever for the product to be approved by the FDA in America before it is made available in Canada. However, it sounds to me as though the company that is making the product may be unwilling to bring the product to market in Canada before they are able to bring it to market in America. If that is the case, it is the company that you need to be complaining to.

  14. Stupid question: … Can I order this by mail if I’m living in the US?

  15. Dear Steve:

    I honestly don’t know. In theory at least there may be some Canadian mail order pharmacies that would be willing to supply it if you can get a prescription.

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