Publication date: Jan 17, 2020
The Food and Drug Administration (FDA)’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and Drug Safety and Risk Management Advisory Committee voted against the approval (0 ‘yes’, 27 ‘no’) of oxycodegol (formerly NKTR-181; Nektar Therapeutics) for the treatment of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Moreover, results from human abuse potential studies showed that the oral abuse potential of the investigational treatment was similar to that of oxycodone; data to assess the abuse potential of oxycodegol via intravenous or intranasal administration were found to be inadequate.
|disease||MESH||Low Back Pain|
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