By RTT News, February 26, 2013, 06:55:00 AM EDT
(RTTNews.com) - AstraZeneca Plc.(AZN, AZN.L) announced high-level results from KODIAC-08, an open-label, randomised, 52-week, long-term safety trial of naloxegol versus usual care or UC in patients with non-cancer related pain and opioid-induced constipation or OIC. UC was defined as the investigator's choice of an existing laxative treatment regimen for OIC.
The company said it was the fourth trial in the naloxegol Phase III development programme, and was designed to evaluate the long-term safety and adverse event or 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, the company noted.
The company stated that 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, the company said.
Naloxegol is part of the exclusive worldwide license agreement announced on 21 September 2009, between AstraZeneca and Nektar Therapeutics ( NKTR ).
Naloxegol is a peripherally-acting mu-opioid receptor antagonist being investigated for the treatment of constipation as a side effect of prescription opioid pain medicines.
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