Primary endpoint was response rate, defined as1,2:
Back pain: 56%
Joint pain: 3%
Back pain: 57%
Joint pain: 5%
Study Design: The KODIAC-04 and KODIAC-05 studies were identical 12-week, phase 3, replicate, randomized, double-blind, parallel group, placebo-controlled studies in 1352 adult patients with chronic non-cancer pain and OIC who received an opioid morphine-equivalent daily dose of between 30 mg and 1000 mg for at least 4 weeks before enrollment. OIC was confirmed during a 2-week run-in period. A total of 652 patients in KODIAC-04 and 700 patients in KODIAC-05, aged 18 to 84 years (mean age 52 years), were randomized to receive MOVANTIK 12.5 mg, MOVANTIK 25 mg, or placebo once daily for 12 weeks. Throughout the studies, patients were prohibited from using laxatives other than bisacodyl rescue laxative and one-time use of an enema. Prior to enrollment, patients had been using their current opioid for an average of 3.6 and 3.7 years, respectively. The patients who participated in KODIAC-04 and KODIAC-05 were taking a wide range of opioids. The mean baseline opioid morphine-equivalent daily doses were 140 mg and 136 mg per day, respectively.1,2
MOVANTIK® (naloxegol) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (eg, weekly) opioid dosage escalation.
You are encouraged to report Adverse Reactions to RedHill Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
RedHill Biopharma Inc. supports the responsible use of medications, including those containing opioids, as treatment options for patients with chronic non-cancer pain.
This site is intended for US health care professionals only.
RedHill Biopharma Inc. (U.S. Office)
8045 Arco Corporate Drive, Suite 200
Raleigh, NC 27617