Ortho-McNeil seeks NDA for premature ejaculation drugJohnson & Johnson's Ortho-McNeil is betting that premature ejaculation, or PE, is the next ED, a mass-market sexual dysfunction with big potential sales.
In December, Ortho-McNeil's Alza filed an NDA for dapoxetine, which would be the first to treat the condition should it win FDA approval.
Mountain View, Calif.-based Alza licensed dapoxetine from PPD GenuPro prior to its acquisition by Johnson & Johnson in 2001.
Alza, which specializes in drug delivery systems, had intended to add the compound to its urology and primary care products portfolio, which included Ditropan XL for overactive bladder, Elmiron for interstitial cystitis and Concerta for ADHD.
Alza, which named Medical Broadcasting Company to handle interactive work for dapoxetine, will present data from Phase III trials in the first half of 2005.