Durect Plunges on FDA Ruling

Shares of Durect (NASDAQ: [[ticker:DRRX]]), a Cupertino-based developer of drug-delivery technologies, fell 30 percent in morning trading to $2.21 after the FDA handed a complete-response letter to licensing partner Pfizer (NYSE: [[ticker:PFE]]) on an extended-release version of the pain drug oxycodone. The product, called Remoxy, is being developed by New York-based Pfizer and Pain Therapeutics (NASDAQ: [[ticker:PTIE]]) of Austin, and it includes anti-tampering technology licensed from Durect. The project has suffered some regulatory hurdles, including a previous complete-response letter issued in December 2008. Pfizer said in a statement that it would work with the FDA to address the issues raised in the current letter. Shares of the New York-based drug giant dipped about 1 percent to $20.28.

Author: Arlene Weintraub

Arlene is an award-winning journalist specializing in life sciences and technology. She was previously a senior health writer based out of the New York City headquarters of BusinessWeek, where she wrote hundreds of articles that explored both the science and business of health. Her freelance pieces have been published in USA Today, US News & World Report, Technology Review, and other media outlets. Arlene has won awards from the New York Press Club, the Association of Health Care Journalists, the Foundation for Biomedical Research, and the American Society of Business Publication Editors. Her book about the anti-aging industry, Selling the Fountain of Youth, was published by Basic Books in September 2010. View all posts by Arlene Weintraub