The label includes a Boxed Warning describing the risk of hepatotoxicity associated with APAP. Most cases of liver injury were associated with APAP doses >4000mg daily and often involved >1 APAP-containing product.
Several clinical trials have demonstrated the SPRINT PNS System to be effective in reducing pain and improving quality of life.
Lucemyra is not indicated as a treatment for opioid use disorder.
In June 2018, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee met and voted against (14-3) the approval of Remoxy upon data review.
Pending approval, CAM2038 may be the first long-acting treatment for OUD in both weekly and monthly formulations.
The recall affects approximately 470,000 units that include drugs packaged with 3 to 10 tablets per blister card. The blister packs were developed for use in hospitals, however some were sent to retail pharmacies and were likely dispensed for in-home use.
Remoxy ER contains oxycodone, a full opioid agonist, and utilizes the Company’s ORADUR technology which is designed to deter abuse via non-oral routes.
Mirtazapine is a central alpha-2 antagonist currently FDA-approved for the treatment of major depressive disorder.
Consensi combines amlodipine besylate, a calcium-channel blocker (CCB), and celecoxib, a nonsteroidal anti-inflammatory drug (NSAID).
Lucemyra, a selective alpha 2-adrenergic receptor agonist, works by reducing the release of norepinephrine and decreasing sympathetic tone.
