Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (the “Company”) today announced that it has submitted a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for its ghrelin agonist, macimorelin acetate (AEZS-130). Phase 3 data have demonstrated that the compound has the potential to become the first orally-approved product that induces growth hormone release to evaluate adult growth hormone deficiency (“AGHD”), with accuracy comparable to available intravenous and intramuscular testing procedures.
David Dodd, President and CEO of Aeterna Zentaris, commented, “The submission of the NDA to the FDA is another major milestone in our strategy to bring macimorelin acetate to market as the first approved oral product for AGHD evaluation. We are also looking at potential expansion into traumatic brain injury victims and pediatrics which would represent significant growth opportunities for the Company. Finally, I would like to congratulate and thank all those involved in our drug development and regulatory affairs departments for this exciting accomplishment.”
Aeterna Zentaris Inc.