The FDA has accepted for review the New Drug Application (NDA) for a first-in-class investigational opioid, NKTR-181 (Nektar Therapeutics), for the treatment of chronic low back pain in adult patients new to opioid therapy.
NKTR-181 is a long-acting selective full mu-opioid agonist; it is not a prodrug or a reformulation of an existing opioid. This novel agent has low permeability across the blood-brain barrier, which slows its rate of entry into the brain and reduces dopamine release.
The NDA is supported by 15 studies involving 2,234 participants. These trials included opioid-naive patients with chronic low back pain (N=600), patients with noncancer pain (N=630), pharmacokinetic/pharmacodynamic studies (N=450), and human abuse potential studies vs oxycodone control.
The FDA has set the Prescription Drug User Fee Act target action date for May 28, 2019.
For more information visit Nektar.com.