Avanafil shows highly positive results in Phase 3 trial for ED

According to a company press release issued earlier today by VIVUS, Inc., avanafil, an investigational agent, was effective in the treatment of erectile dysfunction (ED) in some 77 percent of patients at a dose of 200 mg.

The data are based on the REVIVE (TA-301) clinical trial, a randomized, double-blind, placebo-controlled study that evaluated three doses of avanafil in 646 men with a history of general ED. However, it does have to be stated that this trial explicitly excluded any patient with ED as a consequence of radical prostatectomy, so it would be inappropriate to conclude that avanfil is necessarily going to work in patients with ED as a consequence of treatment for prostate cancer.

Men were randomized to receive one of the following four drug regimens: avanafil 50 mg, avanafil 100 mg, avanafil 200 mg, or a placebo (a sugar pill).

The following key study results were identified in the media release:

  • Nearly 80 percent of sexual attempts among patients on the 200 mg dose of avanafil had erections sufficient for intercourse (compared to 54 percent among patients receiving the placebo).
  • Full efficacy, as measured by successful intercourse, was reported by avanafil patients in 30 minutes or less.
  • Full efficacy was maintained for all doses across multiple time points from 30 minutes to > 6 hours.
  • Avanafil was well tolerated as demonstrated by a retention rate of 85 percent.
  • There were no serious drug-related serious adverse events reported by study participants.
  • Avanafil patients had low reports of common side effects of other PDE5 inhibitors.

The most commonly reported side effects in patients taking avanafil (all doses combined) included headache (7.0 vs. 1.2 percent among placebo patients), flushing (4.6 vs. 0 percent), and nasal congestion (2.3 vs. 1.2 percent). There were no reports of visual disturbances such as “blue vision.”

We are not aware of any trial currently in place to evaluate the potential of avanafil specifically in patients with ED as a consequence of treatment for prostate cancer. However, any expansion in the variety of potential treatments for men with ED holds potential for effectiveness in at least some patients with post-treatment ED, so — based on these data — The “New” Prostate Cancer InfoLink looks forward to the potential future approval of avanafil by the US Food and Drug Administration.

5 Responses

  1. The other ED meds out there seem to work pretty well already but what could be the big “in” for this medication is if it manages to live up to what the company reports about its speed in working and low side effects. I also am unaware of treatment with this medication for those who have had prostate cancer, but if it makes it to market one day, chances are there will be something out eventually on this as prostate cancer unfortunately has affected and continues to affect quite a few men.

  2. This is not really new to the market, no? Except the 15 minutes of difference in getting an erection.

  3. Dear Fran:

    Well avanafil is not a “revolutionary new product” if that is what you mean … but it is a new product, still in development for the treatment of ED. It may work better than currently marketed products for some men and not for others.

  4. Well there is and there will be monopoly of sildenafil citrate when comes to ED. Avanafil already failed. Any updates on this?

  5. I don’t think the manufacturers of Cialis would agree with your assesrtion that sildenafil has a monopoly on the ED marketplace. Also, a media release from Vivus, Inc. last December states that the company will be filing a new drug application for avanafil prior to July 1, 2011, so am not sure where you are getting the idea that avanafil “already failed.”

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