Novel Buprenorphine Sublingual Spray NDA Submitted

Compared to full opioid agonists, buprenorphine causes less cognitive impairment and less constipation
Compared to full opioid agonists, buprenorphine causes less cognitive impairment and less constipation

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. 

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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.