Topline Results from Phase 2 Clinical Trial of Oral (Naskaq: NKTR) Present at Pain Management Meeting
Boca Raton, FL 10/13/2009 01:05 AM GMT (TransWorldNews)
Nektar Therapeutics (Nasdaq:NKTR) presented topline data from its Phase 2 clinical trial of oral NKTR-118 at the American Academy of Pain Management's (AAPM) 20th Annual Clinical Meeting in Phoenix, Arizona. NKTR-118, an oral peripherally-acting opioid antagonist, is a late stage investigational product candidate in clinical development for the treatment of opioid-induced constipation. NKTR-118 was developed by Nektar, utilizing its proprietary small molecule advanced polymer conjugate technology platform.
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The recent presentation at AAPM includes topline data previously announced by the company in March 2009. In a Phase 2 double-blind, randomized, placebo-controlled study of 208 patients with opioid-induced constipation, NKTR-118 met the primary endpoint of increase in spontaneous bowel movements over the baseline period. There was no reversal or reduction of opioid-mediated analgesia in any dose groups. NKTR-118 was also well tolerated with the most commonly reported side effects being dose-dependent gastrointestinal-related effects. Oral NKTR-118 is a peripheral opioid antagonist in development for the treatment of opioid-induced constipation (OIC) and other manifestations of opioid bowel dysfunction (OBD). Depending on the population studied and the definitions used, constipation has been shown to occur in up to 90% of patients taking opioids. Over 200 million opioid prescriptions are filled in the U.S. annually with worldwide sales of opioids reaching $7.5 billion in 2007. There is a significant need for an oral therapy to address the debilitating side effects of chronic opioid use. Oral NKTR-118 applies Nektar's advanced polymer conjugate technology platform with naloxol, a derivative of the opioid-antagonist drug, naloxone. The drug is under development for the treatment of opioid-induced constipation (OIC). Oral NKTR-118 is designed to target peripheral opioid receptors to alleviate constipation associated with opioid therapy, while limiting naloxol's penetration across the blood-brain barrier to preserve the analgesic effects of opioids,
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