FDA Nixes Approval of Buprenorphine Spray for Pain


Today the US Food and Drug Administration (FDA) turned down approval of Buvaya, a buprenorphine sublingual spray (INSYS Therapeutics) for moderate to severe pain resulting from reported safety concerns.

Consistent with the outcome of an FDA Advisory Committee meeting in May, and reported by Medscape Medical News at that time, an FDA advisory committee voted 18 to 1 against approval of the drug.

At that time, the committee commended the company for what they said was an innovative formulation that, at least on the surface, seemed to provide a lower abuse potential than other opioids, as well as some other potential advantages. But they noted both that the efficacy data were not impressive and that a higher incidence of hypoxia, nausea, and vomiting than seen with other opioids was concerning.

The company announced it received a Complete Response Letter from the FDA regarding the company’s New Drug Application for a buprenorphine sublingual spray as a treatment for moderate to severe acute pain.

“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 assess the next steps in the context of the company’s overall mission,” said Steve Sherman, senior vice president of regulatory affairs for INSYS Therapeutics.


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