www.fdanews.com/articles/187916-insys-buprenorphine-spray-draws-complete-response-letter
Insys Buprenorphine Spray Draws Complete Response Letter
August 7, 2018
The FDA issued Insys a complete response letter citing safety concerns over the company’s NDA for a buprenorphine sublingual spray indicated for moderate-to-severe acute pain.
The CRL followed an FDA advisory committee meeting in May that found the company demonstrated statistically significant efficacy data but noted concerns about the safety data.
Insys said it continues to believe that the drug-device combination could provide effective pain management and said it will “assess the next steps in the context of the company’s overall mission.”