Johnson & Johnson suffered a blow yesterday when the US Food and Drug Administration turned down its application for what would have been the first pharmaceutical product to treat premature ejaculation.
More common than erectile dysfunction, this condition can affect men at any point in their lives, and one in four men experience poor control over ejaculation on a frequent basis. This suggests that there is a market to rival the multibillion dollar ED drug sector, so the FDA’s action is a major setback for J&J.
In a letter, the FDA said the application dossier for dapoxetine hydrochloride was ‘not approvable’, although J&J said it plans to continue developing the drug in this indication. It has not revealed why the FDA blocked approval.
Data released earlier this year showed that dapoxetine, designed to be taken a few hours before sex, tripled the duration of intercourse in men who had been with the same partner for at least six months and persistently suffered from PE [[25/05/05c]]. If it reaches the market, dapoxetine would be the first treatment option for patients developed specifically for PE, which at present is managed using behavioural therapy or older, ‘off-label’ drugs.
Dapoxetine is being developed by J&J’s drug delivery subsidiary Alza and Pharmaceutical Product Development. If approved by the FDA, it will be marketed in the USA by J&J’s Ortho-McNeil Pharmaceutical unit.
Dapoxetine has not been submitted for approval in Europe, as J&J has been mindful of the difficulties experienced by Pfizer in persuading European health systems to reimburse its ED drug Viagra (sildenafil) [[16/10/01g]].