CUPERTINO, Calif., Feb. 7 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today that the company expects to complete enrollment of its 50 patient Phase II clinical trial for the company's lead product, DUROS sufentanil, ahead of the previously anticipated date for completion of enrollment. DUROS sufentanil is designed to deliver sufentanil on a continuous basis for 3 months for the treatment of chronic pain. Sufentanil is an off-patent, highly potent opioid that is currently used in hospitals as an anesthetic. Chronic pain, defined as pain lasting 6 months or longer, is a significant problem associated with chronic diseases, including cancer and various neurological and skeletal disorders. DUROS sufentanil is intended for patients whose chronic pain is stable, opioid responsive and results from a variety of malignant and non-malignant causes. Annual sales of opioids for the treatment of chronic pain are in excess of $1 billion.
"We are very pleased at the progress that we have made with our patient enrollment for our Phase II trial for DUROS sufentanil. The accelerated pace exceeds our expectations, and we expect this trial to complete 8-10 weeks ahead of the previously anticipated schedule," said James E. Brown, President and CEO of DURECT. "We believe that this reflects the potential benefits of this product to both patients and physicians. We believe DUROS sufentanil has the potential to be a more convenient, patient-friendly product that may provide an alternative to current therapies for the long term treatment of stable and opioid responsive chronic pain."
DURECT Corporation is pioneering the development and commercialization of pharmaceutical systems to deliver the right drug to the right site in the right amount at the right time. DURECT's pharmaceutical systems combine technology innovations from the medical device and drug delivery industries with proprietary pharmaceutical and biotechnology drug formulations. These capabilities can enable new drug therapies or optimize existing therapies based on a broad range of compounds, including small molecule pharmaceuticals as well as biotechnology molecules such as proteins, peptides and genes. DURECT's initial portfolio of products combine the DUROS technology, a proven and patented drug delivery platform licensed for specified fields of use from ALZA Corporation, with drugs for which medical data on efficacy and safety are available. Founded in 1998, the Company is headquartered in Cupertino, CA. The Company's World Wide Web site can be accessed at http://www.durect.com. To join DURECT's email alert service, please register by selecting "Email Alerts" on the main Investor Relations web page at http://www.durect.com.
DUROS is a registered trademark of ALZA Corporation.
The statements in this press release regarding DURECT's clinical trials, products in development, and expected product benefits are forward-looking statements involving risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, DURECT's ability to successfully complete clinical trials, obtain product approvals from regulatory agencies, develop, manufacture and commercialize its products, build a manufacturing facility, and marketplace acceptance of DURECT's products. Further information regarding these and other risks is included in the company's S-1 registration statement, filed with the SEC on September 22, 2000, its 424(b) prospectus filed with the SEC on September 28, 2000 and its Quarterly Report on Form 10Q for the quarter ended September 30, 2000 filed with the SEC on November 13, 2000.
For further information please contact:
Schond L. Greenway
Director, Investor Relations
Phone: (408) 777-1417
Schond.Greenway@durect.com SOURCE DURECT Corporation
CONTACT: Schond L. Greenway, Director, Investor Relations of DURECT Corporation, 408-777-1417, Schond.Greenway@durect.com/