Source : http://www.neurex.com
Neurex Corporation (NASDAQ/NM: NXCO) today announced that it has completed an interim analysis of data from patients enrolled in its Phase III neuropathic pain trial of ziconotide
which included 105 patients, revealed that the difference in pain reduction between the two groups was substantial with a reduction in pain scores of approximately 40% in one group compared to no change in the placebo griup.
"We were blown away by the difference between the two groups in the neuropathic pain trial. This appears to confirm that the drug
works in these difficult to treat patients. Obviously, we need to complete the analysis on all treated patients before we confirm the
outcome," commented Dr. Goddard. "We have also learned something about the patient population we are treating. Even with a 10-day stay in hospital, one of the groups failed to show any decrease in their pain symptoms. This suggests that the placebo
response in these severely disabled patients is low.
If, as expected, the drug-treated group is the group with marked improvement in
pain symptoms, then this indicates an even stronger treatment effect than we had predicted. Experience to date indicates that
ziconotide has a favorable safety profile and side effects, when present, resolved with dose reduction or discontinuation."
Enrollment for the neuropathic pain study has been completed with over 200 patients enrolled. Final data collection and detailed
analyses have been initiated for an NDA submission.
To support the filing of an NDA, the Company is performing two pivotal trials:
---- 1/ the chronic neuropathic pain trial,
---- 2/ a study is being conducted in chronic malignant (cancer) pain. The malignant pain trial is at its interim goal of 100 patients.
In addition to the short-term studies, a long-term study is also ongoing, which focuses on
the safety of ziconotide when used over an extended time period.
A patient is only eligible for the long-term study if he/she has
responded to ziconotide in the short-term study. Approximately 50% of the total number of trial patients are enrolled in the long-term study.
Pour en savoir plus http://www.neurex.com/clinical/ziconotide.html