J&J Hasn't Given Up On Sex Pill for Men

(July 6, 2007) -- In the hunt for a new sex pill for men, Johnson & Johnson is trying again.

The health-products giant hasn't given up on what it hopes will become the first drug approved for premature ejaculation, even though the U.S. Food and Drug Administration rejected it in 2005. Regulators questioned whether helping men last longer during sex was a clear medical benefit, and may have had concerns about side effects of the drug, dapoxetine. Other companies -- including Pfizer Inc., the maker of Viagra -- have scrapped experimental drugs for the condition since the FDA's thumbs down for J&J's.

Now, J&J will test its luck with dapoxetine outside the U.S. The New Brunswick, N.J., company plans to file for regulatory approval of the drug in Europe and Canada later this year, having completed additional patient studies since 2005 that J&J says demonstrate dapoxetine's safety and effectiveness. J&J hasn't ruled out a second try for FDA approval to sell the drug to American men.

Doctors say demand for such a drug would be strong because about 20% to 30% of men lack control over ejaculation and reach climax sooner than they would like. While hardly a life-threatening disease, premature ejaculation can cause emotional distress for men and their partners.

"If it's bothering a patient and I can give him a way to improve his quality of life, I'm all for it," says Christopher Saigal, assistant professor of urology at UCLA's medical school, who has no financial ties to J&J.

If J&J is successful, dapoxetine could generate world-wide sales of $600 million by 2011, according to Morgan Stanley, assuming the drug goes on sale outside the U.S. in 2008 and in the U.S. in 2009. Market watchers expect J&J to price dapoxetine in the range of Pfizer's anti-impotence drug Viagra, which sells for more than $10 per pill on online pharmacy drugstore.com. J&J hasn't said what it plans to charge for dapoxetine if it reaches the market.

J&J wouldn't be the only drug maker to benefit if dapoxetine makes it to pharmacy shelves. It licensed the compound from Pharmaceutical Product Development Inc., which had previously licensed it from Eli Lilly & Co. Both companies would stand to collect royalties from any sales of the drug.

But hurdles remain, including the concerns that led the FDA to reject the drug in the first place. The FDA has a policy of not commenting publicly on its reasons for rejecting proposed drugs. But a J&J research executive, Paul Stoffels, told reporters last month the agency may not have viewed premature ejaculation as a "real indication," and questioned whether dapoxetine's effect of delaying ejaculation was "a clinical relevant benefit to the patient."

Analysts have suggested the FDA had concerns about side effects and safety. Studies have shown dapoxetine to be associated with nausea and momentary loss of consciousness. Such side effects might continue to be an obstacle for regulatory approval.

But J&J continues to pursue the drug because it views premature ejaculation as a huge, untapped market. Currently, the condition is sometimes treated with a type of antidepressant known as a selective serotonin reuptake inhibitor, or SSRI, such as GlaxoSmithKline PLC's Paxil and Pfizer's Zoloft, although they aren't approved by the FDA for this use. Urologists also recommend certain behavioral techniques and topical ointments to help delay ejaculation.

J&J's dapoxetine is also an SSRI. But unlike those approved to treat depression, dapoxetine is short-acting and designed to be taken "on demand," perhaps an hour or two before a man expects to have sex. For depression, SSRIs are usually taken once a day and stay in the body longer.

Dapoxetine was tested in men who, on average, had been ejaculating about one minute after the start of intercourse, as measured by their partners with stopwatches. Some doctors say a normal range is between three and seven minutes.

In studies, after 12 weeks of treatment, the time until ejaculation increased to about three to four minutes among men taking two different doses of dapoxetine, compared with less than two minutes for those on a fake pill. J&J also said studies showed dapoxetine improved control and satisfaction with sex.

Will a delay of two to three minutes be enough to satisfy men and their partners? Maybe not. In a survey of 102 men with premature ejaculation conducted by research firm Decision Resources in 2005, more than 80% of men said the optimum increase in time to ejaculation would be at least six minutes -- out of range of dapoxetine's average benefit. However, some 47% indicated they would consider using a treatment if it provided a minimum increase of two to five minutes, suggesting some might consider dapoxetine.

One 34-year-old man with premature ejaculation said he would welcome a drug like dapoxetine. The Decatur, Ill., man said in an interview his premature ejaculation has been a "major downfall" for him and his wife during their 12-year marriage. The father of two has tried an antidepressant but it hasn't helped much. "If the drug does what it's supposed to do and helps me, which in turn helps my marriage, then sure," said the man, whose identity is being withheld to spare him and his family potential embarrassment.

J&J conducted two trials of dapoxetine in the U.S., which were included in the FDA application that was rejected in 2005. Since then it has completed additional trials in Europe and Asia, bringing the total number of men tested to about 5,000. Stoffels, the J&J research executive, said the new studies "confirmed the safety and efficacy profile" of dapoxetine. He said the drug was well-tolerated and side effects were mild to moderate.

Another potential concern for dapoxetine, however, is that existing SSRIs have been linked to a higher risk of suicidal thinking and behavior in children and adolescents with depression. J&J hasn't reported any signs of a similar effect with dapoxetine, and the drug was studied in men older than 18 years.

Even if J&J can convince regulators to approve dapoxetine, it won't be simple to market or to convince insurance plans to pay for it. To be sure, the trail for a drug like dapoxetine was blazed by Viagra nearly a decade ago. Viagra's success proved that a drug maker, helped by heavy consumer advertising, could convince people to view an embarrassing, once-taboo condition as a disease in need of treatment.

But Viagra also sparked a backlash against consumer marketing for sexual-dysfunction treatments. Critics have said TV spots for Viagra and its rival drugs have promoted irresponsible use and were inappropriately shown during family entertainment.

J&J may have to take a gentler approach to marketing dapoxetine even in the U.S., which permits TV drug ads unlike most other countries. For one thing, it might be difficult to convey the condition and the treatment in a 30-second TV spot, said Mark Bard, head of Manhattan Research, a health-care market research firm. The 2005 Decision Resources survey showed that most men preferred to receive information about treatments from their doctors, and TV ads were "low on the scale," said Dancella Fernandes, a Decision analyst.

National health plans in Europe might resist paying for a lifestyle drug like dapoxetine, at least initially, Ms. Fernandes said. If the drug makes it to the U.S., it could take time to convince private insurers to cover it. A 2005 Decision Resources survey of U.S. private drug-plan directors found a majority said they wouldn't add dapoxetine to their list of preferred drugs, for which out-of-pocket costs to members are lower. However, Ms. Fernandes suggested insurers might gradually cover such a drug over time.

By: Peter Loftus
Source: Wall Street Journal

Last updated: 07/07

Related Information:

• Preventing Premature Ejaculation
• How Premature Ejaculation Affects Couples and Partners and Your Quality of Life
• What Makes For Good Sex
• Current Safe Sex Education is Not Changing Sexual Risk Behaviour
• Early Adolescent Sexuality: What is Your Child Going Through
• Sex and the Early Teen: What is Going On?
• Getting Your Kids to Say "No" When You Said "Yes"
• Opening the Channels for 'The Sex Talk' With Your Teenager
• Study on American Lad Magazines - Where Boys Learn About Sex
• Can You Be Too Open With Your Kids When It Comes To Sex?
• Talking With Your Kids About HIV and AIDS
• Introduction to HIV
• HIV Prevention

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