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Phase 3 Long Term Clinical Trial Launched for Bicifadine
This clinical trial will enroll approximately 1,550 patients with chronic lower back pain, 1,050 of whom will be entered directly into this study and randomized to receive either 400 mg of bicifadine b.i.d. or any appropriate pharmacological analgesic treatment selected by the investigator. In addition, the clinical trial will enroll approximately 500 patients who will have completed 12 weeks of treatment in either the ongoing Phase III chronic lower back pain clinical trial or the confirmatory Phase III chronic lower back pain clinical trial currently planned for the second half of 2005. Such patients will receive 400 mg of bicifadine b.i.d. The primary objective of this clinical trial is to evaluate the safety of bicifadine for up to one year in patients with chronic lower back pain. This trial is expected to be conducted in approximately 150 centers in the U.S.
In March 2004, DOV and the FDA reached agreement on a plan for the balance of the Phase III bicifadine program necessary to submit an NDA for both acute pain and chronic lower back pain. As part of the NDA package for one or the other indication, the plan requires DOV to conduct a long-term safety clinical trial. The Phase III trial announced today is designed to meet this portion of the overall NDA plan.
Dr. Warren Stern, DOV's senior vice president of drug development, stated, "This study of up to 12 months of dosing with bicifadine is significant in that it is intended to provide evidence regarding the safety of bicifadine required by the FDA as part of the clinical information required in an NDA. From the patient's perspective, this study provides the opportunity to receive long term therapy for his or her chronic lower back pain with a new medication. From a commercial perspective, this trial will provide information related to the pharmacoeconomic impact of bicifadine, information that plays a key role in the acceptance of new treatments by the formulary committees of health management organizations."
Bicifadine is a chemically distinct molecule with a unique profile of pharmacological activity. It is not a narcotic and, in preclinical studies, has been shown not to act at any opiate receptor. In animal models, bicifadine does not demonstrate abuse, addiction or dependence potential.
Drugs for the treatment of pain, or analgesics, have historically been placed into one of two general categories:
-- narcotics, e.g., morphine, codeine, Demerol and Percodan; and
-- non-narcotic prostaglandin inhibitors, e.g., aspirin, acetaminophen, ibuprofen and COX-2 inhibitors.
While drugs in both of these categories are regularly used in the treatment of pain, their use has been limited because of various side effect profiles. In addition, administering these drugs for extended durations has been problematic. Although prostaglandin inhibitors have been used for the treatment of pain, particularly pain associated with inflammation, their efficacy is often limited to milder types of pain and they may display undesirable side effects relating to the gastrointestinal tract and liver. Narcotics are also used to treat pain, but tolerance develops rapidly and higher doses eventually lead to physical dependence and additional side effects, including constipation and respiratory depression. Therefore, we believe patients with moderate to severe pain will benefit from the use of bicifadine. Based on clinical data to date patients are expected to experience pain relief comparable to that associated with a narcotic without the side effects normally associated with this class of drugs. According to IMS, a market research organization, U. S. sales in 2002 of narcotic and non- narcotic analgesics exceeded $5.7 billion.
Source: DOV Pharmaceutical, Inc.