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Cambridge, England (ots/PRNewswire) - New research demonstrates oxycodone/naloxone prolonged-release tablets superiority compared with oxycodone prolonged-release tablets
Treatment with Targin(R)(oxycodone/naloxone) prolonged-release tablets provides superior bowel function without compromising analgesic efficacy or safety when compared with oxycodone prolonged-release tablets alone in adult patients with moderate to severe cancer pain, according to new data published online today in Palliative Medicine.
This was a 4-week, randomised, double-blind, active-controlled, double-dummy, parallel-group study designed to evaluate the safety and efficacy of oxycodone/naloxone prolonged-release tabletsin 185 adult patients with moderate to severe chronic cancer pain.
Improvement in bowel function
The study shows an improvement in bowel function, as measured by the validated Bowel Function Index (BFI), after 4-weeks of treatment in those patients taking oxycodone/naloxone, with a statistically significant difference in the change from baseline in BFI score (incrementBFI) between groups (incrementBFI = -11.14; 95% confidence interval [CI]: -19.03, -3.24; p?0.01). At the same time, the mean total laxative (bisacodyl) intake was 20% lower in the oxycodone/naloxone group (26.10 [27.60] versus 32.69 [31.26] mg respectively; p=0.17).
Over 4 weeks of treatment, Patient Assessment of Constipation Symptoms (PAC-SYM) scores improved in both groups, and the degree of improvement after four weeks was significantly greater for those taking oxycodone/naloxone than for those on oxycodone in terms of total symptom score (p=0.014) and frequency of symptoms (p<0.01).
Analgesic efficacy and tolerability preserved
The mean level of pain control, as determined by the Brief Pain Inventory-Short Form (BPI-SF) scores, was similar for both treatments (3.50 [1.88] and 3.52 [1.80]) after 4 weeks, and the average rate of analgesic rescue medication use was low and comparable. QoL assessments were stable and comparable with greater improvements in constipation-specific QoL assessments with oxycodone/naloxone than oxycodone, and rates of adverse drug reactions were similar in both treatment groups (38.0% versus 34.8%, respectively).
"Many patients with cancer pain need to take strong analgesics, and oxycodone is now one of the established choices we have available," commented Professor Sam H Ahmedzai, University of Sheffield, UK. "However, like other opioids, it can cause constipation. Previous research has shown that the combination of oxycodone with the antagonist naloxone to counteract constipation, worked in patients with severe chronic, non-cancer pain. This new study has shown for the first time that not only is oxycodone/naloxone a reliable analgesic in cancer patients, but it also significantly improves their bowel function. Targin(R) is therefore a major step forward in patient-friendly pain control."
Notes to Editors:
About the study
This was a randomised, double-blind, active-controlled, double-dummy, parallel-group, Phase II study in which 185 patients were randomised to receive up to 120/60 mg/day of oxycodone/naloxone prolonged-release tablets or up to 120 mg/day oxycodone prolonged-release tablets over 4 weeks, designed to evaluate the safety and efficacy of oxycodone/naloxone prolonged-release tablets in adult patients with moderate to severe chronic cancer pain. Please note that Targin(R) is licensed for a maximum daily dose of 80/40mg. Efficacy assessments included the Bowel Function Index (BFI), Brief Pain Inventory short form (BPI-SF), laxative and rescue medication use. Quality of life and safety assessments were conducted.
Bowel Function Index (BFI) is a validated clinician administered, patient reported, three-item questionnaire to assess patient-reported constipation-related symptoms ("ease of defecation", "feeling of incomplete bowel evacuation" and "patient judgment of constipation") rated on a numerical analogue scale between 0-100.
The Brief Pain Inventory Short Form (BPI-SF) is a validated, widely used, self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions.
Targin(R) is a combination of the opioid analgesic oxycodone and the opioid receptor antagonist naloxone in a prolonged-release tablet formulation providing twice-daily dosing.
Targin(R) is licensed for the treatment of severe pain and to counteract opioid-induced constipation, and is marketed across Europe under the brand names Targin(R), Black Triangle DrugTarginact(R)andTarginiq(R).
About Mundipharma International Limited
The Mundipharma/Napp/Norpharma independent associated companies are privately owned companies and joint ventures covering the world's pharmaceutical markets. The companies worldwide are dedicated to bringing to patients with severe and debilitating diseases the benefits of novel treatment options in fields such as severe pain, haemato-oncology and respiratory disease. Prolonged release oxycodone / naloxone was developed by Mundipharma Research. For more information: http://www.mundipharma.co.uk
1. Ahmedzai, S. H., Nauck, F., Bar-Sela, G, et al. A randomized, double-blind, active-controlled, double-dummy, parallel-group study to determine the safety and efficacy of oxycodone/naloxone prolonged-release tablets in patients with moderate/severe chronic cancer pain. Palliative Medicine, September 2011.
2. Targin SmPc. Available at: http://www.medicines.ie/medicine/14 383/SPC/Targin+5+2.5mg%2c+10mg+5mg%2c+20m g+10mg+and+40+20mg+prolonged+release+tablets/ [http://www.medicines. ie/medicine/14383/SPC/Targin+5+2.5mg%2c+10mg+5mg%2c+20mg+10mg+and+40+ 20mg+prolonged+release+tablets ]
3. Rentz AM, van Hanswijck de Jonge P, Leyendecker P, et al. Observational, Noninterventional, Multicentre Study for Validation of the Bowel Function Index for Constipation in European Countries. CMRO 2011;27(1):35-44.
4. Mendoza T, Mayne T, Rublee D, et al. Reliability and validity of a modified Brief Pain Inventory short form in patients with osteoarthritis. Eur J Pain 2006; 10: 353-61
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