has announced that study sites are being recruited for two new Phase IV epilepsy studies and that three epilepsy educational symposia have been scheduled.
Both of the new epilepsy studies are Phase IV, post-approval, multi-center, open-label, parallel-group, active treatment control trials comparing patients with pharmaco-resistant epilepsy treated with adjunctive VNS Therapy™ plus standard of care treatment as usual to patients treated with only standard of care treatment as usual (no VNS). The first study will enroll up to 360 patients over the age of 12 at 40 study sites and compare outcomes over 12 months of treatment in patients who have partial seizures refractory to at least two, but not more than five, anticonvulsant medications. The second study will enroll up to 360 patients over the age of 12 at 40 study sites and compare outcomes over 12 months of treatment in patients who have medically refractory partial seizures and have been determined by video EEG surgical evaluation not to be appropriate epilepsy surgery candidates.
Three national epilepsy educational symposia have been scheduled to occur in July and August 2004. The symposia will provide epilepsy and VNS Therapy education to (1) community patient advocacy groups including Epilepsy Foundation affiliates, (2) epilepsy nurse clinicians and (3) pediatric neurologists who treat patients over the age of 12 with pharmaco-resistant partial onset seizures.
“Cyberonics is firmly committed to its mission to improve the lives of people touched by epilepsy,” commented Robert P. (“Skip”) Cummins, Cyberonics’ Chairman of the Board and Chief Executive Officer. “Considering that VNS Therapy is the only FDA-approved anti-convulsant that is either being studied or is approved as a treatment for major depression, the Panel vote recommending depression approval was a major step forward toward approval of an important, revolutionary new therapy not only for the millions of patients and families living with treatment-resistant depression (TRD), but also for the hundreds of thousands of patients with pharmaco-resistant epilepsy, over 50% of whom suffer from comorbid depression. The combination of a renewed focus on community-based epilepsy patient education, new Phase IV epilepsy studies, new national epilepsy educational symposia and continued progress toward approval of the proposed depression indication as recommended yesterday by FDA’s Neurological Devices Advisory Panel will facilitate growth in the number of new epilepsy patients treated with VNS Therapy and enable Cyberonics to accomplish more of its epilepsy mission. Each of the epilepsy initiatives mentioned here is already included in our Fiscal 2005 guidance.”