FDA rejects INSYS painkiller

Jul 28, 2018

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

Show Comments
Hide Comments

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.


No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments