Challenges in Analgesic Drug Development

As many as 50 million people in the United States suffer from chronic pain. 1 Our most effective analgesics—including opioids, nonsteroidal anti‐inflammatory drugs, anticonvulsants, and antidepressants—are based on mechanisms of action that have been recognized for some time, and in many cases, they provide only 50% pain relief to about 30% of patients. 2 Consequently, there is a need for more effective analgesics.

[1]  M. Rowbotham,et al.  A multicenter, double-blind, randomized, placebo-controlled crossover evaluation of a short course of 4030W92 in patients with chronic neuropathic pain. , 2002, The journal of pain : official journal of the American Pain Society.

[2]  R. Portenoy,et al.  Population-based survey of pain in the United States: differences among white, African American, and Hispanic subjects. , 2004, The journal of pain : official journal of the American Pain Society.

[3]  Abdulmajeed Al Abdukareem Randomized, placebo-controlled trial , 2004, Annals of Saudi medicine.

[4]  S. Daniels,et al.  A randomized controlled study comparing rofecoxib, diclofenac sodium, and placebo in post-bunionectomy pain , 2004, Current medical research and opinion.

[5]  J. Farrar,et al.  Core outcome measures for chronic pain clinical trials: IMMPACT recommendations , 2003, Pain.

[6]  N. B. Finnerupa,et al.  Algorithm for neuropathic pain treatment: An evidence based proposal , 2005 .

[7]  Nathaniel Katz Methodological issues in clinical trials of opioids for chronic pain , 2005, Neurology.

[8]  D. Hewitt,et al.  Fentanyl Iontophoretic Transdermal System for Acute-Pain Management After Orthopedic Surgery: A Comparative Study With Morphine Intravenous Patient-Controlled Analgesia , 2006, Regional Anesthesia & Pain Medicine.

[9]  D. Stanski,et al.  Enriched analgesic efficacy studies: an assessment by clinical trial simulation. , 2006, Contemporary clinical trials.

[10]  David Borsook,et al.  A role for fMRI in optimizing CNS drug development , 2006, Nature Reviews Drug Discovery.

[11]  D. Hewitt,et al.  Fentanyl Iontophoretic Transdermal System for Acute‐Pain Management After Orthopedic Surgery: A Comparative Study With Morphine Intravenous Patient‐Controlled Analgesia , 2006, Regional anesthesia and pain medicine.

[12]  K. Todd,et al.  Tramadol/acetaminophen or hydrocodone/acetaminophen for the treatment of ankle sprain: a randomized, placebo-controlled trial. , 2007, Annals of emergency medicine.

[13]  C. Grady,et al.  Clinical Trials and Medical Care: Defining the Therapeutic Misconception , 2007, PLoS medicine.

[14]  David Weller,et al.  Are electronic diaries useful for symptoms research? A systematic review. , 2007, Journal of psychosomatic research.

[15]  L. Arendt-Nielsen,et al.  Human experimental pain models in drug development: translational pain research. , 2007, Current opinion in investigational drugs.

[16]  Nathaniel Katz,et al.  A 12-week, randomized, placebo-controlled trial assessing the safety and efficacy of oxymorphone extended release for opioid-naive patients with chronic low back pain* , 2007, Current medical research and opinion.

[17]  M. Hyland,et al.  Consistency of the placebo effect. , 2008, Journal of psychosomatic research.

[18]  David Borsook,et al.  A ‘BOLD’ experiment in defining the utility of fMRI in drug development , 2008, NeuroImage.

[19]  L. Leventhal,et al.  Predictive validity of animal pain models? A comparison of the pharmacokinetic–pharmacodynamic relationship for pain drugs in rats and humans , 2008, Neuropharmacology.

[20]  R. Dworkin,et al.  Clinical trial outcome in neuropathic pain , 2008, Neurology.

[21]  A. Light,et al.  Translational pain research , 2018, European Journal of Anaesthesiology.