DOV Pharmaceutical begins phase 2 trial of bicifadine for neuropathic pain

By Angela McDaniels

Seattle, Feb. 6 - DOV Pharmaceutical Inc. said it has begun dosing in a phase 2 clinical trial of bicifadine, its novel analgesic, in patients with painful diabetic peripheral neuropathy.

The randomized, multiple-dose, open-label, two-phase overlap trial - the first study of bicifadine in patients with neuropathic pain - is a 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.

The clinical trial will randomize 50 patients into two parallel four-week treatment groups. 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, the company said.

"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," Warren Stern, senior vice president of drug development, said in a company news release.

"Given the efficacy in preclinical neuropathic pain models and the encouraging efficacy data already collected in our open-label phase 3 clinical trial in chronic low back pain, we believe bicifadine could address the need for improved pain control in diabetic patients with painful neuropathy."

The neuropathic pain market was estimated to be $2.5 billion in the United States and European Union in 2005 and is projected to reach more that $4.1 billion by 2007, according to the release.

Bicifadine is being evaluated in four phase 3 clinical trials: three in chronic lower-back pain patients and one in patients suffering pain after vaginal hysterectomy. DOV said it plans to file its first New Drug Application for bicifadine in chronic lower-back pain in the first half of 2007.

DOV is a biopharmaceutical company based in Hackensack, N.J., that discovers, acquires, develops and commercializes novel drug candidates for disorders that involve alterations in neuronal processing.

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