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Significant Area of Unmet Medical Need
The pain therapeutic category is predominantly made up of two classes: NSAIDs and opioids

NSAIDs are generally used for mild to moderate pain and are associated with serious unwanted side effects:
GI bleeding, CV events, and Hepatotoxicity

Opioids are used for moderate to severe pain due to their strong analgesic effect. However, opioid analgesics also present significant challenges:
  • Dizziness, sedation, nausea & vomiting, respiratory depression (potentially fatal)
  • GI motility issues (result in delay in hospital discharge)
  • Abuse, tolerance, dependence, and addiction

4.3 million Americans aged 12 or older reported non-medical use of prescription pain relievers in 2014. This non-medical use of prescription opioids costs insurance companies up to $72.5 billion annually in health-care costs.

The United States is currently going through an opioid abuse epidemic as 52 people died each day during 2014 from an overdose of prescription painkillers.
 
With limited innovation in many years, there is a real need for pain medications which offer opioid level efficacy without the associated side effects.

Decision Resources Group 2014 study identified four areas of significant unmet need in the acute pain market:
  1. safer and better tolerated analgesics
  2. effective analgesics for opioid-refractory severe pain and/or acute neuropathic pain
  3. effective analgesics able to prevent progression to chronic pain
  4. more-potent, opioid-sparing analgesics for post-operative pain
  
We believe MAX-001 has the potential to address all four key areas of need