INSYS Therapeutics announced that the U.S. FDA declined to approve its opioid painkiller, citing potential safety concerns.
The Arizona-based drugmaker received a Complete Response Letter for its New Drug Application (NDA) for a buprenorphine sublingual spray as a treatment for moderate-to-severe acute pain.
In the letter, the FDA noted that although the clinical development program demonstrated that the proposed doses of the product candidate were statistically significantly different than placebo in providing pain relief, some of the data suggested potential safety concerns.
INSYS is not officially giving up on the drug-device combination, but says it will “assess the next steps in the context of the company’s overall mission.”
Read the press release