Europe may approve J&J's new selective serotonin reuptake inhibitor (SSRI) for premature ejaculation—but don't expect it in the U.S. any time soon. When used to treat PE, the SSRIs cause other problems. The problems are the negative side effects, such as psychiatric problems, skin reactions, weight gain and loss of libido.
On June 7, Johnson & Johnson laid out its plans for new drugs soon to be on the market, and for other drugs still going through the approval process, including a drug for PE.
PE is the most common male sexual problem, even more common than erectile dysfunction, affecting 21 percent to 33 percent of American men.
J&J's new drug, a short-acting SSRI called dapoxetine, has been specifically developed for PE. J&J said it will apply for European Union approval for the drug this year, and is exploring whether to resubmit it to the U.S. Food and Drug Administration (FDA).
Dapoxetine was presented to the FDA in 2005, but was rejected. The FDA advisory panel had concerns the condition (PE) was not an established disease category, and that the drug carried with it serious side effects such as nausea, headache, upset stomach and weakness.
The new drug was studied in two large clinical trials, which were reported in The Lancet in September, 2006. At that time, the lead researcher in the study, Dr. Jon L. Pryor, said dapoxetine worked both in lengthening ejaculation time and in patients feeling they had control over ejaculation.
The trials included 2,614 men who had moderate to severe PE. They were randomly assigned to take a placebo or different doses of dapoxetine.
At the start of the trial, the men ejaculated, on average, in less than a minute after penetration. However, after 12 weeks, the men taking dapoxetine increased their time to ejaculation to 2.78 minutes (for those on a 30-milligram dose), and to 3.32 minutes (for those receiving a 60-milligram dose. For men taking a placebo, at the end of the 12 week trial, the time to ejaculation averaged 1.75 minutes.
So one would think this drug could be helpful.
But the SSRIs have been associated with various other negative side-effects—not just those mentioned above. Pregnant women taking SSRIs have been found to have a higher risk of giving birth to a child with birth defects. Zoloft and the other SSRIs have been linked to an increased risk of child and teen suicide.
The problem with leaving SSRIs in off-label mode as the only treatment for PE is that they have not been clinically tested for this use, and therefore the treatment for these men is something of an experiment.
Who knows what new side effects may appear during, or after, this experiment? It's still too early to tell.