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

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 at http://www.nektar.com/product_pipeline/cns_pain_nktr-181.html:

• Poster #258B, "NKTR-181: An Orally Available Mu-Opioid Agonist with Slow Rate of Uptake into the CNS, Exhibits Comparable Analgesic Efficacy with Reduced Abuse Liability and CNS Mediated Side Effects Compared to Oxycodone"
• Authors: Gogas, 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

About NKTR-181

NKTR-181 is a novel mu-opioid analgesic investigational drug candidate created using Nektar's advanced small molecule polymer conjugate technology.  The unique molecular design of the polymer conjugate is designed to prevent conversion of NKTR-181 into a more abusable form of an opioid.  With slower entry into the CNS when compared to published oxycodone data, NKTR-181 has the potential to greatly reduce the euphoria that underlies opioid abuse liability and dependence.  In addition, NKTR-181 is intended to reduce the other serious CNS-related side effects such as respiratory depression and sedation which are associated with current opioid therapies. 

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