AstraZeneca announces U.S. enrollment opportunities for KODIAC study to investigate an experimental drug for constipation from opioids

Monday, 1 August 2011

AstraZeneca (NYSE:AZN) today announced that study centers across the U.S. are recruiting patients for a clinical study to examine whether an investigational drug is safe and effective in treating opioid-induced constipation (OIC). The study, known as KODIAC, is a Phase III clinical trial examining an investigational drug in patients experiencing constipation as a result of opioid use, which is a potential side effect of prescription opioid pain medications.

Opioids, such as morphine, are commonly prescribed to patients experiencing chronic pain, which can provide relief from serious medical conditions including osteoarthritis, cancer, and chronic back pain.1 In fact, opioids are considered the mainstay for cancer pain management, with up to 70 percent of advanced cancer patients experiencing chronic pain.1 However, pain medicines often may result in debilitating side effects such as constipation.1 There are a variety of strategies used to treat opioid-induced constipation; however, many patients fail to find effective relief.1,2

“Up to 50 percent of patients on opioids can suffer from constipation,”said Jaakko Lappalainen, M.D., Senior Director, Clinical Research, AstraZeneca. “Patients taking opioids and experiencing constipation are encouraged to consider speaking with their physicians about their condition and ask about participation in a clinical trial. The KODIAC study is a clinical trial being conducted to help determine whether AstraZeneca’s investigational drug may be helpful in treating this medical problem.”

Potential participants can learn more about the KODIAC study by watching this short video or visiting painandconstipation.com. Information about the KODIAC study, including patient eligibility, enrollment requirements, and study location sites can be obtained on the Web site or by calling the patient hotline at 866-320-6956.

“AstraZeneca supports clinical trial research examining new treatment approaches,” said Chris Fleischmann, R.N., Study Leader, AstraZeneca. “We encourage sharing knowledge about clinical trials, like the KODIAC study, with interested and eligible participants, as a means of furthering the research community’s efforts to find treatments for conditions like opioid-induced constipation.”

About Opioid-Induced Constipation

Patients taking opioids to treat chronic pain commonly experience a side effect known as opioid-induced constipation, which may include infrequent bowel movements and difficulty passing stools or emptying bowels.1,2 Some studies have shown that up to 50 percent of patients on opioids suffer from constipation.Current treatment options may include laxatives, stool softeners, enemas, or diet alterations, but these remedies are not always helpful and may leave patients seeking additional relief methods.1,2

About the KODIAC Program

The KODIAC Program consists of two randomized, placebo controlled Phase III efficacy studies and an open-label, randomized, placebo-controlled long term safety study. The two efficacy studies are identical with 12-week treatment periods. These studies are intended to evaluate the efficacy, safety and tolerability of an AstraZeneca investigational drug in patients with OIC. KODIAC is part of the KODIAC program of studies looking to determine whether this investigational drug is safe and effective for the treatment of constipation seen as a side effect in people taking prescription opioid pain medications. To learn more about the KODIAC study, please visit painandconstipation.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

For more information about AstraZeneca in the U.S. or our AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).

References
1. Reimer, K et al. Meeting the challenges of opioid-induced constipation in chronic pain management - a novel approach. Pharmacology. 2009; 83:10-17.
2. Johanson, JF and Kraltein, J. Chronic constipation: a survey of the patient perspective. Aliment Pharmacol Ther. 2007; 25:599-608.

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