Otsuka Pharmaceutical announced results from the first phase 3 clinical trial TRIAD 1 & 2, for the treatment of Alzheimer's Agitation. The Otsuka press release from 3-25-19 is here AVP-786. The results from that phase 3 were deemed to be significant for one of the two doses using the Cohen-Mansfield Agitation Inventory with the SPCD design. The other phase three clinical trials will utilize the more standard parallel group, placebo controlled design. The safety profile was similar to other clinical trials which included falls, urinary tract infection, headache and diarrhea. There will be a peered-reviewed journal with a more complete look of the results to follow.
The reported significant results become a positive for Concert Pharmaceuticals who could benefit from a royalty agreement, should the drug achieve FDA approval. The patent for AVP-786 runs to 2030 in the U.S. Thank you for reading.
