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:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.

Study says statins not enough for diabetic hearts

Researchers using an experimental test have discovered that the 50% of surveyed diabetics may also have undetected heart muscle damage.