The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) was split (6 to 6) on its decision as to whether Posimir (bupivacaine extended-release solution; Durect) should be approved for post-surgical analgesia.
The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted against (2 “yes”, 24 “no”) the approval of Aximris XR
As a result of the vote, Nektar has decided to withdraw the New Drug Application for oxycodegol and to cease further development of the product.
A ready-to-use formulation of Caldolor (ibuprofen injection) has been made available by Cumberland Pharmaceuticals.
In an effort to further address the current opioid crisis, the FDA contracted the NASEM to examine existing opioid prescribing guidelines and to help outline the type of research needed to fill the gaps in evidence.
The FDA is requiring new warnings be added to the prescribing information for gabapentinoids about the risk of respiratory depression. This class of drugs includes gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR).
While claims about the benefits of Vivitrol were clearly presented in the ad, serious risks, such as vulnerability to opioid overdose, were not communicated.
If approved, the Company expects that the drug would be classified as a Schedule II controlled substance.
HTX-011 is a dual-acting, fixed-dose combination of bupivacaine and meloxicam.
The FDA has approved Reyvow for the acute treatment of migraine with or without aura in adults.
