Naloxegol (NKTR-118) Scientific and Clinical Data Presentations
Naloxegol (NKTR-118) is a novel peripherally-acting opioid antagonist created using Nektar's advanced polymer conjugate technology. Naloxegol targets mu-opioid receptors within the enteric nervous system, which mediate opioid bowel dysfunction (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. Naloxegol (NKTR-118) is currently in Phase 3 studies to evaluate the safety, tolerability and efficacy of naloxegol in patients with opioid induced constipation.
According to IMS Health, more than 250 million prescriptions were written for opioids in 2010 in the United States, alone. Many studies indicate that a high percentage of patients receiving opioids are likely to experience significant constipation and other symptoms of OBD. Currently, there are no specific drugs approved that are indicated to treat OIC. Stool softeners or laxatives may be ineffective for many patients with OIC and they are often associated with side effects like diarrhea and stomach cramps.
- Poster: 20th AAPM Annual Clinical Meeting October 10, 2009 "NKTR-118 Significantly Reverses Opioid-Induced Constipation"
- Poster #140: ACCP 38th Annual Meeting September 13, 2008 "Comparative Bioavailability of NKTR-118 Tablets and Solution: A Case of Bioequivalence Between Dosage Forms for a Rapidly Absorbed Drug"
- Poster #141: ACCP 38th Annual Meeting September 13, 2008 "NKTR-118, An Oral Peripheral Opioid Antagonist, Has Low Potential for Drug-Drug Interactions"
- Press Release: Nektar Announces Positive Results from Phase 2 Study of Oral NKTR-118 in Patients with Opioid-Induced Constipation (OIC); Highly Statistically Significant Results Achieved at Two Dose Levels with No Reversal of Analgesia March 2, 2009
- Press Release: Oral NKTR-118 Shows Substantial Oral Bioavailability and Extended Half-Life In Phase 1 Clinical Data Presented at American Pain Society Meeting May 7, 2008
- Poster #210: Results from a Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study Evaluating the Safety, Tolerability and Pharmacokinetics of Oral Doses of Oral NKTR-118 (PEG-Naloxol) May 7, 2008
- Press Release: Positive Results for Oral NKTR-118 (oral PEG-naloxol) Presented At American Academy of Pain Management Meeting September 26, 2007
- Poster #27: Clinical Investigation of Oral NKTR-118 as a Selective Oral Peripheral Opioid Antagonist Presented at the American Academy of Pain Management Meeting in Las Vegas, Nevada September 28, 2007
- Poster #28: Oral NKTR-118 (oral PEG-naloxol), a PEGylated Derivative of Naloxone; Demonstration of Selective Peripheral Opioid Antagonism After Oral Administration in Preclinical Models Presented at the American Academy of Pain Management Meeting in Las Vegas, Nevada September 28, 2007
- Press Release: Nektar Presents Positive Results from Phase 1 Clinical Trial of Oral NKTR-118 (oral PEG-naloxol) at American College of Clinical Pharmacology Meeting September 10, 2007
- Poster #36: Evaluation of PEG-naloxol NKTR-118 as an Oral Peripheral Opioid Antagonist in Healthy Male Subjects: A Double-Blind, Placebo-Controlled, Dose Escalation Crossover Study - Presented at the American College of Clinical Pharmacology 36th Annual Meeting in San Francisco, CA September 10, 2007 Poster Session II