Insys Therapeutics gets CRL from FDA for buprenorphine application

Insys Therapeutics announced that it received a Complete Response Letter, or CRL, from the U.S. Food and Drug Administration regarding the company’s New Drug Application for a buprenorphine sublingual spray as a treatment for moderate-to-severe acute pain. “Consistent with the outcome of an FDA Advisory Committee meeting in May, the CRL indicates that, although the clinical development program demonstrated all three proposed doses of the product candidate were statistically significantly different than placebo in providing pain relief, some of the data suggested potential safety concerns. 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 Insys.
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