Emplicure today reported dosing in the first pharmacokinetic study with EMPLI03, intended for the treatment of moderate to severe pain. 12 healthy subjects were given a single dose of an oral buccal tablet and blood samples were collected for analysis of Buprenorphine. Safety and tolerability were followed, and the subjects could leave the clinic after completion of the study as planned. Top line data will be available in the beginning of 2023.
The Emplicure group is developing innovative consumer and pharmaceutical products based on its proprietary bioceramic technology platform, Emplior.
EMPLI03 is being developed as an oral buccal tablet with extended release properties intended for the treatment of moderate to severe pain. The formulation is also designed to limit the potential for manipulation of the tablet for abuse. Supported by its Translational Pharmaceutics® platform Quotient Sciences has established the GMP manufacturing process of EMPLI03 and performed this first pharmacokinetic study for Emplicure.
"We have achieved one of our milestones in the development of a Buprenorphine product for the treatment of moderate to severe pain. With properties that limit abuse, EMPLI03 may contribute to a safer medical treatment", said Håkan Engqvist, CEO of Emplicure.
Pain is a major health issue globally and, in the US, as many as 20% of the population is estimated to suffer from chronic pain and in need of long-term pain relief. Widespread moderate to severe pain is a problem that is associated with high costs for society and individual patients. Opioids are, and will continue to be, an important part of pain treatment.