The study will assess the efficacy of Neurodex in relieving pain in adult patients with distal symmetrical diabetic neuropathy with daily pain in the lower extremities. The clinical trial will be conducted at 40 sites in the US and will include assessment scales completed in the clinic and diary records to assess pain. Patients will be randomized to receive placebo or one of two dose levels of Neurodex.
The clinical trial protocol was reviewed by the FDA through a special protocol assessment (SPA) process. An SPA is a binding agreement between the FDA and the sponsor of a clinical trial documenting that if the study endpoints are met, the results should be sufficient to support approval of an application to market the drug. Avanir expects that this will be the first of two phase III clinical trials needed to submit an application for Neurodex for this indication.
The results of a four-week phase II dose escalation safety study of Neurodex in patients with diabetic neuropathic pain showed that the drug was well tolerated up to the highest target dose. Patients also reported a significant decrease in pain intensity from that reported at baseline. The degree of pain relief increased with the duration of the open label study.
James Berg, vice president of clinical and regulatory affairs at Avanir said: “The results of our previous open-label study of Neurodex in patients with diabetic neuropathic pain were encouraging, and we are eager to explore the potential of Neurodex as a treatment for diabetic neuropathic pain in a larger placebo-controlled study. The goal is to be able to offer a new treatment option for diabetic patients with painful neuropathies.”