Demonstrating that a novel analgesic provides pain relief but does not cause respiratory depression can be a significant challenge. Our Chief Scientific Officer, Dr. Neil Singla, has extensive expertise in clinical trials focusing on the evaluation of respiratory endpoints in analgesic studies.
In a Phase 2b study in acute pain, Dr. Singla and Lotus Clinical Research demonstrated the superiority of a novel opioid analgesic vs. morphine in a key respiratory safety endpoint. “”In this trial, respiratory safety was measured as hypoventilation events, defined as clinically apparent and persistently decreased respiratory rate, respiratory effort or oxygen saturation. In practice, such events can result in interruption of opioid analgesic administration or, if unrecognized and if additional opioids are administered, to more serious consequences.” To read more: http://www.trevena.com/news-details.php?id=11.