Novel Buprenorphine Sublingual Spray NDA Submitted
Insys Therapeutics have announced the submission of a New Drug Application (NDA) for buprenorphine as a sublingual spray formulation for the treatment of moderate-to-severe acute pain.
Buprenorphine is a partial agonist of the mu-receptor and an antagonist of the kappa receptor, which contributes to its analgesic effects; however, the exact mechanism of action is unclear. Literature has shown that compared to full opioid agonists, buprenorphine causes less cognitive impairment and less constipation. This may position buprenorphine as a safe and effective alternative to traditional opioids especially in an outpatient setting.
Steve Sherman, SVP of Regulatory Affairs at Insys stated, “As a partial mu-opioid agonist, it is believed that buprenorphine has less abuse potential than other opioids frequently used in this indication and is thought to have a ceiling effect for respiratory depression.”
For more information visit InsysRx.com.