- OCR4554 is an approved drug used by countless patients world-wide (WW).
- Acetaminophen (APAP) sales
- Dozens of companies have OTC sales
- Tylenol’s 20.3% market share and $850M WW/yr
- Large percentage of population have vulnerable livers and would benefit from safer APAP (Figure 1).
- APAP overdose among most common WW
- FDA has long wrestled with safety vs. efficacy for APAP
- US: 56,000 ER visits/yr
- 100 unintentional deaths/yr
- 51% of all US liver poisonings in 2003
- Used in suicide attempts
- OCR4554 in combination with APAP reduces mortality in vivo (Figure 2).
Imaeda, A. B., Watanabe, A., Sohail, M. A., Mahmood, S., Mohamadnejad, M., Sutterwala, F. S., … & Mehal, W. Z. (2009). Acetaminophen-induced hepatotoxicity in mice is dependent on Tlr9 and the Nalp3 inflammasome. The Journal of clinical investigation, 119(2), 305. [Pub Med]