MedicalResearch.com Interview with:
John Douglas Markman, M.D.
Director, Translational Pain Research Program
Department of Neurosurgery
University of Rochester School of Medicine and Dentistry
MedicalResearch.com: What is the background for this study?
Response: Peripheral nerve injury after trauma and surgery is a leading cause of chronic pain and disability. These pain syndromes are often considered to have an underlying neuropathic mechanism because there is altered sensory processing (e.g., numbness, allodynia) at the site of trauma or surgical incision that localizes to the anatomic distribution of a peripheral nerve. A previous eight-week randomized clinical trial demonstrated efficacy for pregabalin in patients with chronic post-traumatic or -surgical pain.(10) The longer duration of treatment of this study was designed to meet the regulatory standard for a chronic pain indication in the US, 12 weeks of treatment at maintenance or fixed dosing.
MedicalResearch.com: What are the main findings?
Response: This randomized, double-blind, parallel group study of subjects with c (PTNP) did not demonstrate a statistically significant treatment effect with pregabalin compared to placebo on mean pain intensity scores at the pre-specified primary efficacy endpoint of the study, week 15. Patients treated with pregabalin did show improvement on many secondary measures including: their overall impression of treatment benefit, improved sleep, and measures of function. The efficacy of pregabalin for post traumatic neuropathic pain should be studied further. The best population to focus on might be patients with a history of chronic nerve pain after surgery like joint replacement or hernia repair.
MedicalResearch.com: What should readers take away from your report?
Response: The unmet need for better treatments for chronic nerve pain after trauma is a serious problem. This was the largest and longest placebo-controlled clinical trial of pregabalin or any other drug for chronic nerve pain after trauma ever conducted.
There is no drug specifically indicated for these chronic pain syndromes in the United States, and it may not be possible to predict who will experience pain relief for the long term for trauma-related nerve pain based on studies in other painful syndromes like post herpetic neuralgia or diabetic peripheral neuropathy.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: The efficacy of pregabalin for post traumatic neuropathic pain should be studied further. The best population to focus on might be patients with a history of chronic nerve pain after surgery like joint replacement or hernia repair.
Dr. Markman has participated in advisory boards (Pfizer, Editas Medicine, Flexion Therapeutics, Teva, Quark, Pacira, Inspirion Delivery Sciences, Quartet, Pacira Egalet, Biogen, Nektar, Endo, Immune Pharma, Chromocell, Collegium, Purdue, Novartis, Sanofi, Convergence, Aptinyx, Daiichi Sankyo, Allergan, Plasmasurgical, and Grunenthal), received research funding (Depomed, Pfizer), and served on Data Safety Monitoring Boards (Allergan, Novartis).
John Markman, Malca Resnick, Scott Greenberg, Nathaniel Katz, Ruoyong Yang, Joseph Scavone, Ed Whalen, Gabriela Gregorian, Bruce Parsons, Lloyd Knapp.Efficacy of pregabalin in post-traumatic peripheral neuropathic pain: a randomized, double-blind, placebo-controlled phase 3 trial.Journal of Neurology, 2018; DOI: 10.1007/s00415-018-9063-9
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