"The FDA's input into the development plan for LevoCap ER was thorough and constructive, and will help ensure that the NDA meets current approval standards for opioid analgesics," said Richard Mangano, Ph.D., chief scientific officer of Relmada Therapeutics. "This will benefit both patients and physicians by providing information about the safe and effective use of LevoCap ER."
In recent weeks, Relmada exchanged correspondence and held a meeting with the FDA Division of Anesthesia, Analgesia, and Addiction Products. The interaction was constructive, with the FDA indicating interest in reviewing clinical protocols supporting an NDA filing for LevoCap ER in the U S
"Although details of the final development plan and phase III protocol have not yet been established, the required steps are realistic and the project is economically feasible," said Mangano. "This development is a significant achievement that will help in the search for the optimal partner to bring LevoCap ER to market and make it a commercial success."
Relmada Therapeutics is a clinical-stage, publicly traded biotechnology company developing novel versions of proven drug products together with new chemical entities that potentially address areas of high unmet medical need in the treatment of central nervous system (CNS) diseases.
