"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
Nektar requested Fast Track designation from the
NKTR-181 has completed a Phase 1 clinical development program, which evaluated its pharmacokinetics, pharmacodynamics and safety in more than 180 healthy subjects. The Phase 2 development program for NKTR-181 will use a standard, randomized, placebo-controlled withdrawal design to evaluate the efficacy and safety of this new opioid molecule in up to 200 patients with chronic pain from osteoarthritis of the knee. A human abuse liability study is also planned as part of NKTR-181's Phase 2 development.
Under the FDA Modernization Act of 1997, the Fast Track program facilitates interactions with the
About Opioids and Pain Management
Pain is the most common symptom for which patients seek medical attention.(1) According to the
About Nektar
Nektar's technology has enabled seven approved products in the U.S. or
Nektar is headquartered in
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," "could," "potential," "may" and similar references to future periods. Examples of forward-looking statements include our current views as to the potential of NKTR-181 as a new approach to opioid analgesia and pain therapy; the potential of NKTR-181 to be less attractive as a target of user abuse than standard opioid therapies; the potential of NKTR-181 to exhibit reduced CNS-related side effects associated with standard opioid therapies; our plans to initiate a Phase 2 clinical study for NKTR-181 in
Nektar Investor Inquiries: |
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(415) 482-5585 |
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(212) 966-3650 |
Nektar Media Inquiries: |
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(650) 575-1509 |
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(415) 794-8662 |
(1) 2011
(2) IMS, NSP,
(3) Melnikova, I, Pain Market, Nature Reviews Drug Discovery, Volume 9, 589-90 (
(4) Joint Meeting of the
(5) Morbidity and Mortality Weekly Report (MMWR), Emergency Department Visits Involving Nonmedical Use of Selected Prescription Drugs ---
SOURCE
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