New Drug Application to the U.S. FDA

Nektar Therapeutics Announces Submission of a New Drug Application to the U.S. FDA for NKTR-181, a First-in-Class Investigational Opioid to Treat Chronic Low Back Pain in Adult Patients New to Opioid Therapy

https://finance.yahoo.com/news/nektar-therapeutics-announces…

Nektar Therapeutics (NKTR) today announced submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for NKTR-181, a new molecular entity (NME) and the first analgesic opioid molecule to exhibit a reduced incidence of specific CNS-mediated side effects, such as euphoria, through the targeted alteration of brain-entry kinetics.

“The submission of the NDA for NKTR-181 is an important milestone for Nektar, and we would like to thank our employees, investigators, clinical trial sites and most importantly the patients and families of those living with chronic pain for all of their help in the development of this medicine,” said Steve Doberstein, Ph.D., Senior Vice President of Research and Development and Chief Development Officer at Nektar Therapeutics. “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.”

Continued…

Dominic
Long NKTR

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