DOV Pharmaceutical Inc. has initiated dosing in a phase II clinical trial of bicifadine, its novel analgesic, in patients with painful diabetic peripheral neuropathy.
This is the first study of bicifadine in patients with neuropathic pain. The trial is a randomised, multiple-dose, open-label, two-phase overlap trial designed to assess the efficacy and safety of bicifadine and potential interactions of bicifadine and oxycodone used concurrently. DOV expects to complete dosing in the third quarter of this year, states the company release.
The clinical trial will randomise 50 patients with painful diabetic neuropathy into two parallel four-week treatment groups. In this trial, patients will receive either bicifadine or oxycodone alone for two weeks and then both drugs in combination for the remaining two weeks. Analgesic efficacy will be determined at the end of each two-week period using patient scores on the Visual Analog Scale for pain - the trial's primary endpoint. Secondary efficacy endpoints include patient ratings of global improvement and use of rescue medication.
"Preclinical studies of bicifadine show the drug has substantial analgesic effects in models of neuropathic pain in both diabetic animals and in animals with sensory neuron damage near the spinal cord," said Dr. Warren Stern, senior vice president of drug development, DOV.
"Given the efficacy in preclinical neuropathic pain models and the encouraging efficacy data already collected in our open label phase III clinical trial in chronic low back pain, we believe bicifadine could address the need for improved pain control in diabetic patients with painful neuropathy," added Dr. Stern.
Bicifadine is currently being evaluated in four phase III clinical trials: three in chronic low back pain (CLBP) patients and one in patients suffering pain after vaginal hysterectomy. DOV intends to file its first NDA for bicifadine in CLBP in the first half of 2007. Phase III clinical trials have already demonstrated that bicifadine is effective in treating severe to moderate pain following dental surgery and bunionectomy.
DOV is a biopharmaceutical company focused on the discovery, acquisition, development and commercialisation of novel drug candidates for central nervous system and other disorders, including cardiovascular, which involve alterations in neuronal processing.