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

Novartis apologizes for slow reporting

Novartis is apologizing to Japan after the Ministry of Health, Labor and Welfare said the company had dragged its feet reporting adverse events for two of its cancer drugs.

J&J pulls morcellator from market

The company is calling the move a withdrawal, as opposed to a recall.

Pfizer buys two Baxter vaccines

The meningitis and encephalitis medications earned a combined $300 million last year.