Opiant Pharmaceuticals (NASDAQ:OPNT), a specialty pharmaceutical company developing pharmacological treatments for addictions, today announced positive data from a Phase I clinical study of its product candidate OPNT003 and provided an update on a meeting held February 8, 2018 with the U.S. Food and Drug Administration (FDA) regarding its planned development program.
As quoted in the press release:
“We are pleased with the positive outcome of this meeting and the beneficial guidance received from the FDA,” said Roger Crystal, M.D., Chief Executive Officer of Opiant. “We now have a well-defined development and regulatory pathway to pursue approval of OPNT003 in the U.S. for the treatment of opioid overdose. Following the feedback received from the FDA, we are focused on leveraging the 505(b)(2) development pathway that allows certain information required for NDA approval to be derived from studies not conducted by Opiant. We anticipate submitting an NDA for OPNT003 in 2020. Based on its profile and the Phase I trial results, we believe OPNT003 has the potential to be a transformative treatment for opioid overdose, a growing U.S. health epidemic.”