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Nektar Commences Phase 2 Trial of NKTR-118 (oral PEG-naloxol) Evaluating Efficacy and Safety as Treatment for Opioid-Induced Bowel Dysfunction
Date:1/8/2008

tment period. The primary efficacy endpoint of the trial will be the increase from baseline in spontaneous bowel movements per week (SBMs per week). Additional endpoints include monitoring of other symptoms of OBD, which will include the Patient Assessment of Constipation Symptoms (PAC-SYM) outcomes tool, and other quality of life measures. Maintenance of opioid analgesic effect will be assessed by measuring changes from baseline in mean daily opioid requirements and daily pain scores. Safety and tolerability will be assessed and pharmacokinetics of the drug will be evaluated. The trial will be conducted in approximately 50 centers in North America and Europe.

About NKTR-118

NKTR-118 is an oral drug that combines Nektar's advanced small molecule PEGylation technology platform with naloxol, a derivative of the opioid-antagonist drug, naloxone. In preclinical studies, Nektar's PEGylation technology has been shown to reduce penetration of drugs across the blood-brain barrier, an important potential advance for NKTR-118 and possibly many other small molecule therapies.

The peripheral opioid antagonist NKTR-118 targets opioid receptors within the enteric nervous system, which mediate OBD, a symptom complex resulting from opioid use that encompasses constipation, bloating, abdominal cramping, and gastroesophageal reflux. Constipation is the hallmark of this syndrome, and is generally its most prominent component. Currently, there are no specific drugs approved or specifically indicated to treat OBD or OIC. NKTR-118 has been studied in two Phase 1 trials evaluating the safety, tolerability and pharmacokinetics of single and repeated dose administration of the drug.

In a proof-of-principle Phase 1 trial, single oral doses of NKTR-118 antagonized morphine-induced delay in gastrointestinal transit time demonstrating the potential of the drug to relieve constipation caused by opioid treatment. This effect was seen to increase in a dose-dependent fas
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SOURCE Nektar Therapeutics
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