FDA Committees Vote on Novel Opioid for Chronic Low Back Pain

FDA Committees Vote on Novel Opioid for Chronic Low Back Pain

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.

Concepts Keywords
Abuse Potential Drugs
Analgesic Psychoactive drugs
Blood Brain Barrier Opioids
Brain RTT
FDA Euphoriants
Hepatic Morphinans
Inadequate Pain
Intranasal Administration Oxycodone
Intravenous Analgesic
Nektar Heroin
Opioid Ketamine
Opioid Receptor Agonist Low back pain
Oxycodone Investigational treatment
Pain Hepatic injury
Indication limits product


Type Source Name
disease MESH development
drug DRUGBANK Oxycodone
disease MESH Low Back Pain


Original Article

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