O2P Oral Overdose Protection

In developing our SMART™ opioids with O2P™ Technology, we have achieved human proof-of-concept, demonstrating an unprecedented product profile with features to reduce the risk of abuse, misuse, diversion and fatal overdose, while providing the unmatched efficacy of opioids.

The Problem

In their current state, opioids are easy to abuse and overdose. The primary route of abuse is simply swallowing too many pills. Euphoria increases with the number of tablets consumed. This creates incentive to take more, which can lead to abuse, opioid use disorder, and overdose. Additionally, the pain management effects of these opioids are short-acting, requiring more pills to be prescribed, resulting in ample opportunity for diversion, abuse and overdose.

 

Our SMART™ Solution

We have demonstrated human proof-of-concept (hPOC) that O2P delivers therapeutic hydrocodone at prescribed doses for unmatched opioid efficacy, and reduces exposure when supratherapeutic doses are swallowed. This safeguards against abuse and overdose. Further,  O2P provides a longer duration of action, reducing the number of tablets prescribed and, in turn, the risk of abuse, diversion, and overdose. Our O2P technology is broadly applicable to other medications with supratherapeutic dose risks that could lead to abuse, overdose or other adverse, life-threatening events.

 

Human Data Demonstrates Unprecedented Safety and Efficacy Profiles

  • Self-limiting exposure protects against abuse and fatal overdose

    O2P’s self-limiting exposure provides efficient delivery of hydrocodone within the prescribed dose range, while reducing exposures when supratherapeutic doses are ingested (~50% in an 8- and 16-tablet overdose).

  • O2P Hydrocodone human proof-of-concept supports acute pain indication

    Steady-state exposure of hydrocodone for O2P hydrocodone provides known effective levels of hydrocodone with twice-daily dosing compared to generic hydrocodone taken every 4 to 6 hours, dramatically reducing the number of prescribed tablets.

  • O2P human data supports chronic pain indication

    The hydrocodone exposure from O2P Hydrocodone is very similar to a previously approved chronic pain reliever, Zohydro® (ER hydrocodone).