Alzamend Neuro submits AL001-PTSD01 IND application to FDA

Alzamend Neuro announced that it has submitted an investigational new drug, or IND, application to the FDA for the initiation of study AL001-PTSD01, a Phase IIA plasma/brain pharmacokinetics clinical study of AL001 for treatment of patients with PTSD. After receipt of a “study may proceed” communication from FDA, Alzamend plans to initiate a Phase IIA study to characterize AL001 improvements of lithium levels in the brain compared to a marketed lithium salt in PTSD patients. Alzamend anticipates that the new drug application, or NDA, development program for PTSD may, for safety, qualify for a 505 NDA pathway to FDA approval, which can be available to new formulations of an approved drug.