J&J completes three late-phase studies of Priligy

WILMINGTON, N.C. Drug maker Johnson & Johnson’s research division finished three phase 3 studies of a drug for treating premature ejaculation, contract research firm PPD confirmed Wednesday.

The studies, by J&J Pharmaceutical Research & Development, increased the number of patients in the clinical data set for the drug Priligy (dapoxetine) to more than 6,000. The company announced its intention to review the new dataset with the Food and Drug Administration.

PPD collaborated with ALZA Corp., an affiliate of J&J division Janssen-Cilag, to develop Priligy, which is approved in Finland, Sweden, Portugal, Austria, Germany, Italy and Spain, but was rejected by the FDA in 2005.

“Our hope is that these data will provide additional safety and efficacy information in support of the Priligy new drug application,” PPD CEO Fred Eshelman said. “We are pleased that our partner Janssen-Cilag continues to obtain clinical data for Priligy in pursuit of additional marketing approvals.”