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Phase 3 Trial of Bicifadine Launched
The clinical trial is a randomized, double-blind, placebo-controlled, outpatient, multi-center study that assesses the efficacy and safety of three dose levels of bicifadine for a five-day period incorporating tramadol as an active control. The primary efficacy endpoint is the Summed Pain Relief and Intensity Difference (SPRID) score, a widely recognized measurement of analgesia. Secondary endpoints include time-to-use of rescue medication, clinical global evaluations and other measures. 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. This clinical trial is expected to serve as one of the four pivotal studies required to support the NDA filing for the management of acute pain.
Dr. Warren Stern, DOV's Senior Vice President of Drug Development, stated, "With the initiation of this trial, our first pivotal Phase III study following the end of our Phase II meeting with the FDA, we begin an important new chapter in the life of the company. This study is the beginning of our large-scale, Phase III bicifadine program for the management of acute pain and chronic lower back pain. Two prior clinical trials with bicifadine demonstrated that it is an effective analgesic in a dental pain model with efficacy superior to placebo and comparable to, or better than, codeine and tramadol. We expect this new Phase III clinical trial to build upon the acute pain model efficacy database. We are selecting two additional acute pain models required to support an acute pain NDA application and plan to initiate those clinical trials in the first half of 2005. In addition, we plan to initiate, in the first quarter of 2005, the long-term safety clinical trials necessary to support both the acute pain and the chronic lower back pain NDA applications."
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 the 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.