Emplicure AB, announced top-line results from an exploratory pharmacokinetic study with Empli03 in healthy volunteers Empli03 is an oral buccal tablet containing the opioid buprenorphine for the treatment of moderate to severe chronic pain. Empli03 was well tolerated with no local irritation. However, the desired plasma concentrations did not reach the target profile for a controlled-release oral buccal tablet.

The objectives of this exploratory study were to examine the safety and tolerability of Empli03, and to analyze the plasma concentrations of buprenorphine. Twelve healthy volunteers were dosed with a single oral buccal tablet placed under the upper lip for six hours and blood samples were collected throughout the study. All healthy volunteers completed the study, and no local irritation was observed in the oral mucosa.

The tablet was easy to keep in place and was well accepted by the volunteers. Buprenorphine is approved to treat opioid use disorder and pain in major markets, including the US and EU. It is a partial agonist at the mu receptor, which results in a lower risk of respiratory depression compared with full agonists, such as oxycodone and fentanyl.

The US Department of Health and Human Services recommends buprenorphine over full agonists for patients who suffer from pain and need treatment with opioids. The safety profile of buprenorphine together with properties that limit abuse are important features that can contribute to a safer medical treatment of pain.