Johnson & Johnson unit Janssen-Cilag is hoping to become the first company to get approval for a treatment that can tackle the problem of premature ejaculation.

The company has put in a marketing authorisation application in Europe for dapoxetine, a treatment for premature ejaculation in men aged 18-64. The submission has been made under the decentralised procedure, in which Sweden will act as the reference member state, while Austria, Finland, Germany, Italy, Portugal and Spain will act as the concerned member states for the application. Other filings around the world are expected to follow.

The filing is based on five Phase III clinical trials involving over 6,000 subjects from 30 countries. Janssen says the results of all randomised studies were consistent, and improvements included both increases in average intravaginal ejaculatory latency time and improved patient-reported outcomes of increased control over ejaculation, as well as reduced personal distress related to the condition. The most common side effects were headache, dizziness, nausea, diarrhoea, insomnia and fatigue.

Dapoxetine, a selective serotonin reuptake inhibitor which Janssen says is the first oral pharmacologic agent developed specifically for PE, is licensed from PPD and J&J will be hoping that the filing is more successful in Europe than it has been in the USA. Just over two years ago, the Food and Drug Administration issued a ‘not approvable’ letter and while no specific reason was given, observers believe that the agency’s opposition was based on some of the side effects SSRIs can come with, notably psychiatric problems.

The disorder affects up to 30% of men in Europe and the USA so the market for a PE product is considerable. Leading the firms challenging Janssen is the UK’s Plethora Solutions Holdings which has just moved its topical spray, PSD502, into late-stage trials.