Ensysce Biosciences receives FDA feedback on PF614 manufacturing

Ensysce Biosciences (ENSC) announced that the Food and Drug Administration provided Written Responses to a meeting request. Ensysce had requested guidance on its approach to the manufacture of PF614, wanting to understand the appropriateness of regulatory starting materials (RSMs) and specifications for PF614 drug substance and the RSMs. In its written responses, the Agency agreed with all of Ensysce’s proposed plans. These responses provide Ensysce with a direct path to commercial production of PF614, which is currently being initiated with its manufacturing partner, Purisys, a subsidiary of Noramco. Dr. Jeff Millard, Chief Operating Officer of Ensysce who lead the CMC effort stated “We are extremely pleased with the FDA’s feedback, which validates our approach and enables us to accelerate PF614’s path to market. This milestone brings us closer to providing safer pain relief options for patients in need.”