A 52-Week Study of Bicifadine in Patients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

An Open-Label 52-Week Safety Study of Bicifadine SR in Adult Outpatients With Chronic Peripheral Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

This study is to evaluate the long-term efficacy and safety of two dosages of bicifadine SR (600 mg/day and 1200 mg/day) for up to 52 weeks in reducing chronic peripheral neuropathy pain due to diabetes in adult outpatients.

Inclusion Criteria:

• Male or female
• 18 years or older
• Diagnosis of type 1 or type 2 non-insulin dependent diabetes mellitus
• Chronic bilateral pain due to diabetic neuropathy, pain for at least six months.
• Primary pain is located in the feet.
• Subject participated in and completed the XTL 07-001 clinical trial.

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Exclusion Criteria:

• Symptoms of other painful conditions
• Presence of amputations other than toes
• Clinically significant psychiatric or other neuropsychological disorder
• Use of certain medications
• Clinically important other diseases
• Pregnancy
• History of alcohol or narcotic abuse within two years.

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