Pharmacological management of spinal cord injury: current status of drugs designed to augment functional recovery of the injured human spinal cord.
Spinal cord injury often results in devastating physical, psychological, and economic disabilities. Research efforts are directed toward providing prognostic outcome data and animal models that parallel the human disorder, thereby elucidating the mechanisms responsible for its dismal clinical prognosis. Investigators continue to search for pharmacological agents that halt the cascade of events that lead to loss of function after cord injury. The scientific and federal regulatory processes by which new drugs are discovered and implemented clinically permit clinicians to evaluate the potential benefits of any new agent, and provide an estimate of the duration required for promising new agents to be made clinically available. Understanding these processes makes the task of classifying the availability status of new drugs much simpler, allowing rational dissemination of realistic information to patients and their families frequently made desperate for viable alternatives to the prospect of permanent paralysis. In this review, we describe the scientific and regulatory processes necessary for the clinical introduction of new drugs using spinal cord injury as an example. A classification scheme based on current Food and Drug Administration regulations is presented that provides drug availability status at a glance. It is hoped that such an organizational scheme will be of practical benefit to clinicians involved in the management of spinal cord-injured patients.
Greene
K A
KA
Division of Neurological Surgery, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA.
Marciano
F F
FF
Sonntag
V K
VK
D000818:Animals; D002121:Calcium Channel Blockers / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004353:Drug Evaluation, Preclinical; D018691:Excitatory Amino Acid Antagonists / Q000627:therapeutic use; D016166:Free Radical Scavengers / Q000627:therapeutic use; D005938:Glucocorticoids / Q000627:therapeutic use; D006805:Human Experimentation; D006801:Humans; D018696:Neuroprotective Agents / Q000145:classification / Q000627:therapeutic use*; D026902:Potassium Channel Blockers; D011379:Prognosis; D013119:Spinal Cord Injuries / Q000188:drug therapy*; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration
D002121:Calcium Channel Blockers; D018691:Excitatory Amino Acid Antagonists; D016166:Free Radical Scavengers; D005938:Glucocorticoids; D018696:Neuroprotective Agents; D026902:Potassium Channel Blockers