Ortho-McNeil seeks NDA for premature ejaculation drug

Share this article:
Johnson & 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.
Share this article:

Email Newsletters

More in Business Briefs

Penn and Teller give take on vaccines

The Las Vegas twosome give the anti-vaccination movement their signature treatment.

GSK allegations build in Jordan and Lebanon

GlaxoSmithKline says it is investigating allegations of employee misconduct. The company said in a statement that the allegations have numbers "very similar to those reported by other companies in our sector."

Generic Celebrex is coming

Pfizer and Teva's settlement puts generic Celebrex on the market by December.