DARA BioSciences Announces New Analysis of Patient Self-Reported Diary Results in a Phase 2a Clinical Trial of KRN5500 in Patients With Cancer and Neuropathic Pain - Drugs.com

http://tinyurl.com/7tmt942

DARA BioSciences Announces New Analysis of Patient Self-Reported Diary Results in a Phase 2a Clinical Trial of KRN5500 in Patients With Cancer and Neuropathic Pain

"....Previous analyses of the study data were based predominantly on patient-reported Numeric Rating Scale (NRS) pain scores collected by healthcare professionals in a clinic setting during weekly visits, whereas this new analysis focused specifically on self-reported daily pain scores from patients' diaries. Responders in this analysis were defined as patients attaining a clinically-meaningful (at least 20%) improvement in mean NRS scores from baseline within any given week. Of the 12 patients who received KRN5500 in this 19-patient trial, 7 (58%) were classified as responders. Further, 5 of the 7 (71%) showed sustained pain relief over several weeks. Of the 7 patients who received placebo, none were responders. Therefore, the new analysis showed a temporal consistency of pain relief in a larger fraction of patients than had been noted in the earlier analysis of weekly clinic-reported pain. These findings are impressive since patients enrolled in this proof-of-concept trial had unrelenting pain at baseline despite the concomitant use of other approved analgesic agents........

 

abstract - Journal of Pain and Symptom Management - A Spicamycin Derivative (KRN5500) Provides Neuropathic Pain Relief in Patients With Advanced Cancer: A Placebo-Controlled, Proof-of-Concept Trial

ScienceDirect.com - Journal of Pain and Symptom Management - A Spicamycin Derivative (KRN5500) Provides Neuropathic Pain Relief in Patients With Advanced Cancer: A Placebo-Controlled, Proof-of-Concept Trial

Conclusion

This proof-of-concept study for KRN5500 in patients with advanced cancer and any type of neuropathic pain found gastrointestinal adverse events to be the predominant safety concern. The results also provided the first indication of clinical and statistical efficacy in reducing pain intensity.