NDA for First-of-Its-Kind Opioid Analgesic Submitted to FDA
The NDA is based on data from 15 clinical studies.
A New Drug Application (NDA) has been submitted for NKTR-181 (Nektar Therapeutics), an opioid analgesic molecule designed to provide pain relief with fewer CNS-mediated side effects such as euphoria.
NKTR-181 is a long-acting selective full mu-opioid agonist; it is not a prodrug or a reformulation of an existing opioid. This investigational agent has low permeability across the blood-brain barrier, which slows its rate of entry into the brain and reduces dopamine release.
Given its 14-hour elimination half-life, the treatment is being evaluated as a twice-daily regimen for pain control.
The NDA is based on data from 15 clinical studies (N=2234). 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.
Steve Doberstein, PhD, Chief Development Officer at Nektar Therapeutics said "This innovative investigational medicine separates analgesic efficacy from the high levels of euphoria that too often lead to the abuse and addiction of traditional opioids."
For more information visit Nektar.com.