"In our evaluation of 18 patients in this pilot Phase III study, we successfully converted patients from the Duragesic(R) product to the CHRONOGESIC product without observing clinically-relevant side effects or adverse events," stated Dr. Lowell Reynolds, the investigator for this study conducted at Loma Linda University Medical Center, Loma Linda, California. "The CHRONOGESIC product represents a significant advancement in pain therapy, and upon approval, will add a valuable tool to the treatment options for all pain clinicians."
DURECT has developed a clinical strategy to permit safe transition from a variety of different opioid medications to the CHRONOGESIC product, an osmotic implant that continuously delivers sufentanil for three months. This strategy requires that patients, who are presently using a variety of opioid medications be transitioned initially to a single opioid medication, the Duragesic(R) product, a 3-day transdermal fentanyl patch. After this brief transition period, patients then receive the CHRONOGESIC product.
As part of this transition strategy, DURECT will leverage the extensive experience already available on how to transition patients from a variety of opioids to the Duragesic product. To convert patients from the Duragesic product to the CHRONOGESIC product, DURECT had to determine the relative potency of sufentanil (the active agent in the CHRONOGESIC product) to fentanyl (the active agent in the Duragesic product). In September 2001, DURECT completed a Phase II trial that determined that sufentanil was 7.5 times more potent than fentanyl.
The objective of this pilot phase III study was to confirm the potency ratio of sufentanil to fentanyl, determined in the Phase II study, and that this transition strategy works to safely transition patients from the Duragesic product to DURECT's CHRONOGESIC product.
Overall Study Design and Plan
The study was a single center 6-week trial consisting of patients whose primary opioid medication was the Duragesic product. Eighteen patients with moderate to severe chronic pain associated with a variety of malignant and non-malignant causes participated in the study.
Each patient included in the study underwent the transition process and received the corresponding CHRONOGESIC therapy based on the potency ratio determined during the Phase II study. Patients remained on the CHRONOGESIC therapy for up to six weeks. The primary outcome measures for the pilot Phase III study were the patient's pain status and opioid consumption before and after implant of the CHRONOGESIC product.
In the recently completed pilot Phase III study, patients were safely transitioned from the Duragesic product to the CHRONOGESIC product. During the 6-week implant period, patients were evaluated for overdose and overall opioid consumption. There was no evidence of patient overdose at any point in time. The median reduction in opioid consumption other than from the CHRONOGESIC product (i.e., the fraction of opioid dosing that was replaced by the CHRONOGESIC product) was 72%.
Patients were also asked about the adequacy of their pain treatment. Seventy eight percent (78%) of patients reported either an improvement or no change in their pain scores. Additionally, there were no significant adverse events related to the CHRONOGESIC product.
Based on the absence of overdose and the substantial replacement of opioid medications by the CHRONOGESIC product, this pilot Phase III study confirms the accuracy of the potency ratio determined in the Phase II trial. The study also demonstrates that patients can be transitioned safely from the Duragesic product to the CHRONOGESIC product.
Pivotal Phase III Program
The primary objectives of DURECT's pivotal Phase III program are to demonstrate that patients can be safely transitioned from a variety of existing opioids, such as pills and patches, to the CHRONOGESIC product, as well as to demonstrate that the CHRONOGESIC product provides pain relief at least equivalent to the patient's existing pain therapy. The program will include placebo-controlled safety and efficacy studies in the U.S. Studies will also be conducted to compare the CHRONOGESIC product to an active control therapy to support European registration. The program will also include an open-label study to evaluate re-implant procedures and long-term safety and efficacy.
DURECT Corporation is pioneering the development and commercialization of pharmaceutical systems for the treatment of chronic debilitating diseases and enabling biotechnology-based pharmaceutical products. DURECT's goal is 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 focuses on the treatment of chronic diseases including pain, CNS disorders, cardiovascular disease and cancer. DURECT holds an exclusive license from ALZA Corporation to develop and commercialize products in selected fields based on the DUROS(R) implant technology. The CHRONOGESIC product, a 3-month continuous infusion subcutaneous implant for the treatment of chronic pain, is the first product in this series and completed phase II testing in June 2001. DURECT also owns three proprietary drug delivery platform technologies, including the SABER(TM) Delivery System (a patented and versatile depot injectable useful for protein delivery), the MICRODUR(TM) Biodegradable Microparticulates (microspheres injectable system) and the DURIN(TM) Biodegradable Implant (drug-loaded implant system). DURECT also commercializes ALZET(R) Osmotic Pumps for research animal use, IntraEAR(R) catheters which have been used by physicians to treat inner ear disorders and PLGA based biodegradable polymers.
Founded in 1998, DURECT 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.
NOTE: CHRONOGESIC(TM), IntraEAR(R) and ALZET(R) are trademarks of DURECT Corporation. SABER(TM), MICRODUR(TM) and DURIN(TM) are trademarks of Southern BioSystems, Inc., a wholly owned subsidiary of DURECT Corporation. DUROS(R) and is a trademark of ALZA Corporation. Other trademarks referred to belong to their respective owners.
The statements in this press release regarding DURECT's products in development, expected product benefits, product development plans, future clinical trials or potential product markets 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 research, develop, manufacture and commercialize its products, obtain product and manufacturing approvals from regulatory agencies, manage its growth and expenses, finance its activities and operations, as well as marketplace acceptance of DURECT's products. Further information regarding these and other risks is included in DURECT's Current Report on Form 8-K filed with the SEC on January 11, 2002, Quarterly Report on Form 10-Q for the quarter ended September 30, 2001 filed with the SEC on November 13, 2001, and Annual Report on Form 10-K for the fiscal year ended December 31, 2000 filed with the SEC on March 30, 2001, under the heading "Factors that may affect future results." CHRONOGESIC is under development by DURECT and has not been submitted or approved for commercialization by the US Food and Drug Administration or other health authorities.
SOURCE DURECT Corporation
Schond L. Greenway, Senior Director,
Investor Relations and Strategic Planning of DURECT Corporation,
+1-408-777-1417, or email@example.com
URL: http://www.durect.com http://www.prnewswire.com