FDA Advisory Committee Fails To Agree On Approval Of Non-opioid Painkillers

- Jan 23, 2020-


Recently, the U.S. FDA Advisory Committee discussed the marketing application of the non-opioid postoperative pain reliever Posimir developed by Durect, with a voting result of 6: 6. The FDA advisory committee has not yet reached consensus on the approval of this non-opioid painkiller.

Posimir is a non-opioid analgesic containing bupivacaine anesthetic developed by Durect, which is suitable for pain management after surgery. It can be used topically in a surgical incision to relieve pain in the first three days after surgery. Based on data from Posimir in two key studies, Durect submitted a listing application for Posimir in 2014. However, the FDA has not approved Posimir's marketing application due to its safety and tolerability, especially neurological adverse events such as drowsiness, dizziness, and taste disorders. Subsequently, Durect undertook another PERSIS study and resubmitted Posimir's listing application. This time, some members of the advisory board expressed concern about nausea, vomiting, and bruising in patients treated with Posimir, and expressed doubts about the duration of its analgesic effect. In addition, they expressed concern about the way Posimir was administered directly into the surgical incision, and members of the committee called for further research into the effects of intravenous administration.

The US FDA has stepped up regulation of opioid use, prohibiting abuse and overuse of opioids. Just a few days ago, the FDA advisory committee opposed the marketing application of Nektar's mu-opioid receptor agonist NKTR-181 (loxicodegol) with a full vote of 27: 0. Although it has significantly reduced pain scores in patients who have not used opioid receptor drugs in back pain in trials, it is not an anti-abuse dosage form and is hepatotoxic. Although opioids face survival difficulties, painkillers remain a huge unmet medical need. Unfortunately, new painkillers have also faced various problems in the past 10 years, which has led the FDA to hope to provide patients with a new non-opioid analgesic to help patients alleviate pain. Hold reservations. (from Bioon.com,compile hsppharma.com)