Insys Buprenorphine Spray Draws Complete Response Letter

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 drugmaker demonstrated statistically significant efficacy data but noted concerns about the safety data.

The company said it continues to “believe that this drug-device combination could bring value to the management of pain and will assess the next steps in the context of the company’s overall mission.”