Cyberonics' (CYBX) VNS Therapy Effective at Reduce Depressive Symptoms
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Cyberonics, Inc. (Nasdaq: CYBX) today announced the results of a multicenter, double-blind, randomized dosing study conducted as a condition of the FDA approval for VNS Therapy for patients with chronic and recurrent treatment-resistant depression in July 2005. This dosing study showed a consistent, sustained and clinically meaningful decrease in depression symptoms across all treatment groups as measured by multiple validated depression assessment scales. Four physician-rated depression scales and one patient-rated depression scale used in this study showed that adjunctive VNS Therapy provided efficacy that improved over time at all dosing levels. After long-term (50 weeks) treatment with VNS Therapy, overall depression symptom improvement ranged from 32.4% to 42.0%; response rates ranged from 26.7% to 53.3%; and remission rates ranged from 14.6% to 22.5% as measured by the five depression assessment scales.
D-21 compared the safety and effectiveness of adjunctive VNS Therapy administered at different stimulation levels to 331 adult patients enrolled at 29 U.S. study centers. Patients were randomized to receive one of three stimulation levels (low, medium or high) during the acute phase (22 weeks). The study design allowed patients in the low and medium stimulation groups to receive increased levels of stimulation after 22 weeks. Patients were followed in the study for a total of 54 weeks.
Patients participating in this dosing study were experiencing very severe levels of chronic and recurrent treatment-resistant depression that had been unresponsive to multiple antidepressant treatments. Key characteristics and demographics of study participants include:
Patients receiving high stimulation did not show significantly greater improvement than those receiving medium or low stimulation at the end of the 22-week acute phase (the primary outcome measure). However, there was a statistically significant decrease in depression symptoms across all five depression scales over time, a secondary efficacy endpoint.
The overall trend and magnitude of depression symptom decrease is consistent with prior long-term VNS Therapy studies in similar patient populations experiencing chronic and recurrent treatment-resistant depression. Likewise, treatment-emergent side effects were similar to those previously reported for VNS Therapy in other studies.
"Chronic and recurrent treatment-resistant depression is a very debilitating illness—many of these people suffer for years without any improvement despite numerous treatment trials. Additionally, these patients are rarely included in clinical studies and very few effective treatment options exist for them," stated Charles R. Conway, M.D., Associate Professor of Psychiatry at Washington University School of Medicine and research faculty at St. Louis University School of Medicine. "In my 10 years of research and clinical use of VNS Therapy, I have seen unparalleled efficacy in a patient population for whom multiple standard-of-care treatments have failed. The long-term sustained efficacy seen with this treatment is particularly compelling and unique."
"The results of this post-market dosing study add to the growing body of evidence for adjunctive VNS Therapy in a severely ill patient population where multiple prior treatments have failed," said Dan Moore, President and CEO. "Efficacy that improves over time and lasts long-term in this patient population has been demonstrated in multiple studies involving approximately 1,000 patients. With these results in hand, we are continuing to evaluate our alternatives for addressing payer coverage and reimbursement and developing a business around the depression indication, while maintaining focus on our core epilepsy business."
D-21 compared the safety and effectiveness of adjunctive VNS Therapy administered at different stimulation levels to 331 adult patients enrolled at 29 U.S. study centers. Patients were randomized to receive one of three stimulation levels (low, medium or high) during the acute phase (22 weeks). The study design allowed patients in the low and medium stimulation groups to receive increased levels of stimulation after 22 weeks. Patients were followed in the study for a total of 54 weeks.
Patients participating in this dosing study were experiencing very severe levels of chronic and recurrent treatment-resistant depression that had been unresponsive to multiple antidepressant treatments. Key characteristics and demographics of study participants include:
- Mean length of illness (years): 27.6
- Mean age (years): 48.0
- Mean length of current depressive episode (years): 9.0
- Mean number of unsuccessful drug treatments (lifetime): 14.5
- Percent previously attempting suicide (lifetime): 47.0
- Percent treated with electroconvulsive therapy (ECT) (lifetime): 57.4
- Mean number of lifetime hospitalizations for mood disorder: 3.5
Patients receiving high stimulation did not show significantly greater improvement than those receiving medium or low stimulation at the end of the 22-week acute phase (the primary outcome measure). However, there was a statistically significant decrease in depression symptoms across all five depression scales over time, a secondary efficacy endpoint.
The overall trend and magnitude of depression symptom decrease is consistent with prior long-term VNS Therapy studies in similar patient populations experiencing chronic and recurrent treatment-resistant depression. Likewise, treatment-emergent side effects were similar to those previously reported for VNS Therapy in other studies.
"Chronic and recurrent treatment-resistant depression is a very debilitating illness—many of these people suffer for years without any improvement despite numerous treatment trials. Additionally, these patients are rarely included in clinical studies and very few effective treatment options exist for them," stated Charles R. Conway, M.D., Associate Professor of Psychiatry at Washington University School of Medicine and research faculty at St. Louis University School of Medicine. "In my 10 years of research and clinical use of VNS Therapy, I have seen unparalleled efficacy in a patient population for whom multiple standard-of-care treatments have failed. The long-term sustained efficacy seen with this treatment is particularly compelling and unique."
"The results of this post-market dosing study add to the growing body of evidence for adjunctive VNS Therapy in a severely ill patient population where multiple prior treatments have failed," said Dan Moore, President and CEO. "Efficacy that improves over time and lasts long-term in this patient population has been demonstrated in multiple studies involving approximately 1,000 patients. With these results in hand, we are continuing to evaluate our alternatives for addressing payer coverage and reimbursement and developing a business around the depression indication, while maintaining focus on our core epilepsy business."
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