Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
News, developments and strategies related to eClinical, data management, data collection, ePRO, and more information technology used in the drug development chain. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
|
See our 2012 Buyers Guide Digital Edition.
 
|
AstraZeneca Announces Results From Long-Term Safety Trial Of Naloxegol In Patients With Opioid-Induced Constipation
Publish date: Feb 26, 2013
PR Newswire SAN FRANCISCO, Feb. 26, 2013
SAN FRANCISCO, Feb. 26, 2013 /PRNewswire/ -- AstraZeneca today
announced high-level results from KODIAC-08, an open-label, randomised, 52-week, long-term safety trial of naloxegol versus
usual care (UC) in patients with non-cancer related pain and opioid-induced constipation (OIC). UC was defined as the investigator's
choice of an existing laxative treatment regimen for OIC. This is the fourth trial in the naloxegol Phase III development
programme, and was designed to evaluate the long-term safety and adverse event (AE) profile of naloxegol in patients taking
25 mg once daily, as compared to UC. In the trial, a total of 534 patients received naloxegol once daily for up to 52 weeks, while 270 patients received UC
for OIC during the same treatment period. The most commonly reported AEs occurring more frequently on naloxegol than on usual
care included abdominal pain, diarrhoea, nausea and headache. The trial reported no imbalances in serious adverse events (SAEs).
In addition, there were a low number of major adverse cardiovascular events (MACE), as adjudicated by an independent external
committee, and there was no imbalance of these events across naloxegol and UC arms. There were no increases from baseline levels in mean daily pain scores or mean total daily opioid dose in either the naloxegol
or the UC arm. Additionally, there were no reports of opioid withdrawal AEs which could be attributed to naloxegol. A full
assessment of the safety and tolerability findings is ongoing. "These high-level results are similar to the safety results seen in the Phase III studies previously reported and provide
further confidence in the data we've seen to date for naloxegol," said Briggs Morrison, M.D.,
Executive Vice President, Global Medicines Development, AstraZeneca. "We have now completed our core Phase III programme and
we are pleased to advance naloxegol toward a regulatory submission later this year." A New Drug Application (NDA) filing in
the US and a Marketing Authorisation Application (MAA) filing in the EU are planned for the third quarter of 2013, pending
AstraZeneca's final preparation of the registration package and a pre-NDA meeting with the FDA. The core Phase III KODIAC programme for naloxegol is comprised of four clinical trials, designed to investigate the safety
and efficacy of naloxegol for the treatment of OIC in patients with non-cancer related pain. Three trials reported high level
results in November 2012, including KODIAC-04, -05 and -07. KODIAC-04 and -05 were pivotal 12-week
efficacy and safety trials, while KODIAC-07 was a 12-week safety extension of KODIAC-04. Full results from KODIAC-04 and -05 will be presented at Digestive Disease Week (DDW), 18-21 May,
2013. Full results from KODIAC-07, along with KODIAC-08, will be presented at a scientific meeting later in 2013. Naloxegol is part of the exclusive worldwide license agreement announced on 21 September 2009,
between AstraZeneca and Nektar Therapeutics (NASDAQ: NKTR). Naloxegol is currently considered a Schedule II controlled substance by the US Drug Enforcement Administration (DEA) based
on structural relatedness to noroxymorphone. AstraZeneca has conducted the studies necessary to evaluate the abuse potential
and dependence-producing properties of naloxegol in support of obtaining decontrol. A petition for the decontrol of naloxegol
was submitted to the DEA in March 2012 and subsequently accepted for review. Commercialisation
and launch in the US will be subject to both FDA approval and DEA schedule determination.
About Naloxegol Top-line results of the Phase II study of naloxegol (formerly NKTR-118) were previously presented at the American College
of Gastroenterology Annual Clinical Meeting and the American Academy of Pain Management Annual Meeting. Naloxegol was developed
using Nektar's oral small molecule polymer conjugate technology.
About Opioid-Induced Constipation Globally, approximately 40–50% (28-35 million) of patients taking opioids for long-term pain develop constipation.
About 40–50% (11-18 million) of those OIC sufferers achieve the desired treatment outcomes with current options that
include over-the-counter and prescription laxatives.
About Nektar
About AstraZeneca SOURCE Nektar Therapeutics
|
|
|
|
|
Facebook
Quizzes
