Johnson and Johnson ‘to continue work on PE drug’

Despite regulatory setbacks in recent years, Johnson & Johnson is continuing its efforts to gain approval for a drug to treat premature ejaculation (PE), it has been claimed.

The Wall Street Journal reports that, while there continued to be regulatory concern regarding adverse affects and debate on the medical benefit of such a drug, the company will continue its efforts to gain approval in some markets for selective serotonin reuptake inhibitor (SSRI) dapoxetine.

Dapoxetine was rejected for use as a treatment for PE by the US Food and Drug Administration in 2005, but Johnson & Johnson is reportedly looking to seek regulatory approval for the compound for this purpose in Europe later this year following additional patient studies.

“If it’s bothering a patient and I can give him a way to improve his quality of life, I’m all for it,” Christopher Saigal, assistant professor of urology at the medical school of UCLA told the newspaper.

Lawyersandsettlements.com speculates that though the compound may be approved in Europe as a treatment for PE, it is unlikely to gain US approval in the short term, with its listed side effects including skin reactions, potential weight gain, loss of libido and psychiatric problems.

In September 2006, the results of a phase III clinical study published in the Lancet revealed that administration with dapoxetine can extend time before ejaculation by 2.78 minutes for a 30 mg dose and 3.32 minutes for a 60 mg dose.