The New Drug Application for a new sublingual spray formulation of buprenorphine to treat moderate to severe acute pain has been rejected by the FDA.
Insys Therapeutics confirmed in a press release that it received a Complete Response Letter from the agency regarding its application.
“Given the attributes of our proprietary buprenorphine formulation for sublingual delivery, we continue to believe that this drug–device combination could bring value to the management of pain and will