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Nektar Announces that FDA Grants Fast Track Designation to NKTR-181, a New Oral Opioid Analgesic Molecule, for the Treatment of Moderate to Severe Chronic Pain
Date:6/7/2012

SAN FRANCISCO, June 7, 2012 /PRNewswire/ -- Nektar Therapeutics (NASDAQ: NKTR) announced today that the U.S. Food and Drug Administration (FDA) has designated NKTR-181 as a Fast Track development program for the treatment of moderate to severe chronic pain.  NKTR-181 is a novel mu-opioid agonist molecule, which is designed to have a slow rate of entry into the brain to reduce the attractiveness of the molecule as a target of abuse and to reduce its CNS-mediated side effects. NKTR-181 was created using Nektar's proprietary polymer conjugate technology and its potential differentiating properties are inherent to the design of the new molecule.  NKTR-181 is an NCE and as a new molecular structure does not rely on a formulation approach to prevent its conversion into an abusable form of an opioid.

"We are very pleased that the NKTR-181 development program has been granted Fast Track designation and we look forward to working closely with the FDA on this program," said Robert Medve, MD, Chief Medical Officer of Nektar Therapeutics.  "NKTR-181 could have significant advantages over currently-available opioids, including reduced attractiveness for abuse and reduced CNS-mediated side effects, such as sedation and respiratory depression.  As a new chemical entity with these properties, we believe NKTR-181 has the potential to transform the treatment of chronic pain.  We are excited about advancing NKTR-181 into Phase 2 development in July of this year." 

Nektar requested Fast Track designation from the FDA for NKTR-181 based upon what is known about its safety and efficacy profile to-date from both preclinical and Phase 1 clinical studies, as well as NKTR-181's potential to treat chronic pain conditions with an improved safety profile over existing therapies. Given the properties and potential of NKTR-181 in the treatment of chronic pain, Nek
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