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Nektar Presents Positive Proof-of-Concept Clinical Data for Its New Opioid Molecule, NKTR-181, at American Academy of Pain Medicine's 28th Annual Meeting
Date:2/27/2012

ly-mediated and peripherally-mediated analgesic effects.  A pupillometry test was used as an indicator of the onset of opioid effect.  Statistical analyses are based on a repeated-measure mixed model analysis of variance.

NKTR-181 was generally well-tolerated at all dose levels in the study: most adverse events were mild and no serious adverse events were reported.  Most frequent adverse events (AEs) observed at the highest doses tested were mild and consistent with AEs characteristic of an opioid agonist, such as constipation, headache and nausea.  There was no observed respiratory depression with NKTR-181 at doses up to 400 mg twice-daily.

The multiple ascending dose study is the second study in the Phase 1 clinical program for NKTR-181.  Positive results from the first Phase 1 study, which was a single ascending dose trial in 110 healthy subjects, were presented at the American Academy of Pain Management (AAPM) Annual Meeting in September 2011. 

NKTR-181 is currently being prepared for Phase 2 development in chronic pain patients in mid-2012.

Data Presentations at 2012 AAPM Meeting

Clinical data from the Phase 1 multiple ascending dose study for NKTR-181 is available on Nektar's website at http://www.nektar.com/product_pipeline/cns_pain_nktr-181.html:

  • Poster #282B, Presentation Title: "Multiple Dose Pharmacokinetics and Pharmacodynamics of the New Oral Opioid Analgesic NKTR-181"
  • Authors:  Webster, et al.
  • Program Track: Poster Session 2: Epidemiology/Health Policy/Education, Pharmacological, Translational
  • Date and Time: Friday, February 24 starting at 5:45pm-7:15pm Pacific time through Saturday, February 25 at 11:15am Pacific

Preclinical data from multiple preclinical studies for NKTR-181 is available on Nektar's website
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SOURCE Nektar Therapeutics
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2. Positive Data for Nektars New Mu-Opioid Analgesic Molecule to Treat Acute Pain Highlighted at Neuroscience 2011
3. Nektar Therapeutics Reports Third Quarter 2011 Financial Results
4. Nektar to Announce Financial Results for the Third Quarter of 2011 on Wednesday, November 2, 2011, After Close of U.S.-Based Financial Markets
5. Nektar Therapeutics President and CEO, Howard W. Robin, to Present at the UBS 2011 Global Life Sciences Conference in New York City
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7. Nektar Therapeutics Reports Second Quarter 2011 Financial Results
8. Nektar to Announce Financial Results for the Second Quarter of 2011 on Thursday, August 4, 2011, After Close of U.S.-Based Financial Markets
9. Nektar Therapeutics President and CEO Howard W. Robin to Present at the Jefferies 2011 Global Healthcare Conference in New York
10. Nektar Announces New Phase 2 Data for NKTR-102 to Be Presented at 2011 ASCO Annual Meeting
11. FDA Grants Orphan Drug Designation for Nektars Investigational Drug, NKTR-102, for Treatment of Women with Ovarian Cancer
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