Nektar Therapeutics submitted an application to the U.S. Food and Drug Administration for NKTR-181 to treat chronic low back pain in adult patients new to opioid therapy.
The San Francisco-based biopharmaceutical company said NKTR-181, a new molecular entity, is an opioid molecule that has reduced occurrences of central nervous system-related side effects, such as euphoria.
The new molecular entity designation indicates that a drug in development is not a version or derivative of an existing and previously investigated, trialed and approved substance.
Nektar said the medicine "separates analgesic efficacy from the high levels of euphoria that too often lead to the abuse and addiction of traditional opioids."
The new drug application includes data from 15 studies in 2,234 subjects.
In March 2017, the company said that the phase 3 trial of the drug met its main goal of improved chronic back pain relief without the high levels of euphoria which can lead to abuse and addiction with standard opioids.
