SAN FRANCISCO, Dec. 13, 2011 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced positive data from a Phase 1 clinical study of NKTR-181 evaluating multiple ascending oral doses of NKTR-181 over an 8-day treatment period in healthy subjects. NKTR-181 is Nektar's new oral opioid analgesic candidate designed to address the abuse liability and serious central nervous system (CNS) side effects associated with current opioid therapies. In this multiple dose Phase 1 study, NKTR-181 exhibited a sustained analgesic response, supporting its development as a twice-daily oral tablet for the treatment of chronic pain conditions. Pupillometry data from the study demonstrated that NKTR-181's centrally-mediated opioid effects are dose-dependent and that the molecule enters the brain slowly, which could reduce the euphoria and other CNS side effects that are associated with current opioids. NKTR-181 was also well-tolerated over the entire 8-day dosing period in the study at all doses evaluated.
NKTR-181 is a novel mu-opioid agonist molecule created using Nektar's proprietary polymer conjugate technology and its differentiating properties are inherent to the design of the new molecule. As a new molecular structure, NKTR-181 is unique in that it does not rely on a formulation approach to prevent its conversion into a more abusable form of an opioid.
"NKTR-181 is emerging as an exciting new development in the treatment of chronic pain," said Lynn R. Webster, MD, Medical Director of Lifetree Clinical Research. "The positive findings from both of the Phase 1 studies for NKTR-181 demonstrate that NKTR-181 has a unique and highly attractive therapeutic profile that is inherent to its new molecular structure. As a novel opioid that could provide sustained analgesia with less CNS side effects and euphoria than existing opioids, NKTR-181 provides great promise for pain practitioners and for patients."
In the Phase 1 multiple ascending dose study, NKTR-181 produced a dose-dependent and sustained analgesic response in a model of pain used in healthy subjects to measure central analgesic activity. NKTR-181 exhibited predictable dose-linear pharmacokinetics across all dose levels with an average half-life of approximately 12 hours and no evidence of pharmacological tolerance over the 8 days of twice-daily dosing. The sustained central response, analgesic effect and safety profile over a 12-hour period supports a twice-daily (BID) dosing schedule.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV