Our goal is to develop a non-opiate, pen-injectable product that harnesses the proven activity of glucocorticoids to treat chronic pain, but improves the safety profile of these agents.
Hypothesis. Glucocorticoids act on several molecular targets in pain act at the nuclear level to modulate key genes involved in inflammatory processes. Our hypothesis is that by localizing dose to the intraneuronal environment, we minimize dose to the site of action in the neuronal cell body, limit systemic administration and thus limit systemic side effects. In other words, improve therapeutic index of glucocorticoids by localizing or “targeting” dose to the affected dermatome.
Inadequate treatment of pain is the single largest cost problem in the Veterans Administration and in the civilian population. Cost in the system to treat pain is driven largely by ineffective drugs, so that patients return to the physician repeatedly for re-evaluation and new combinations of various classes of drugs. In the civilian population pain is the most frequent reason that patients seek medical care, accounting for about 1.5% of all healthcare visits. (Taylor 2006) This is estimated to cost America about $100 billion in direct and $100 billion in indirect costs (Clark 2007).
The total cost of all treatment for Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF, in Afghanistan) returnees was estimated at $350 - $650 billion in 2007 (Clark 2007). Assuming 47% of OEF/OIF returnees seek treatment for pain, this suggests that the cost of treating their pain is $150 - $300 billion.
“... [I]t is expected that about 50% of all OIF/OEF servicemembers will eventually access VA healthcare”... of these, about half of OEF/OIF returnees (47%) will seek treatment for pain, and half of these will receive opiate therapy along with other, often CNS-active pain drugs. (Clark 2007)
Need to reduce opiates in pain care. There are many types of drugs prescribed to treat pain. Most of these agents including the anti-convulsants gabapentin (Neurontin®) and carbemazepine (Dilantin®, antidepressants, NMDA antagonists, opiates like Oxycontin®, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) like Celebrex® and capsaicin act on extracellular, usually single, molecular targets. However, the most effective but provide relief only to about 30%-50% of patients with chronic pain (Sindrup and Jensen 2000; Sindrup and Jensen 1999; Woolf and Mannion 1999; Baron 2000).
Of those being treated for pai
