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

Loading...
Loading...
External Data Analysis Confirms Earlier Published Drug Efficacy Signal in Patients With Treatment-Refractory Neuropathic Pain DARA to Continue Phase 2 Development Program After Formulation Refinement DARA BioSciences, Inc.
DARA
announced today that it will advance development of its novel Phase 2 drug candidate for the treatment of neuropathic pain in patients with cancer. DARA's decision to proceed was based on an additional in-depth analysis of Phase 2a data from a study previously reported in the October 2011 on-line edition of Journal of Pain and Symptom Management. The new analysis was conducted by an external biostatistician with extensive FDA experience. 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. "There are very few effective treatment options for patients with cancer and neuropathic pain, making this an area of significant unmet medical need," stated David J. Drutz, M.D., CEO of DARA. "We are further encouraged by this additional analysis that has shown persistence of KRN5500 pain relief in many patients despite only once-weekly intravenous administration."
Loading...
Loading...
Posted In: NewsFDA
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...