Purdue Pharma

About: Purdue Pharma is a company organization based out in Pickering, Ontario, Canada. It is known for research contribution in the topics: Buprenorphine & Chronic pain. The organization has 622 authors who have published 691 publications receiving 31545 citations. The organization is also known as: Purdue Pharmaceuticals L.P..

Long-term safety and clinical effectiveness of controlled-release metoclopramide in cancer-associated dyspepsia syndrome: a multicentre evaluation.

Abstract: Patients with cancer frequently report gastrointestinal symptoms such as anorexia, early satiety, nausea, vomiting, and bloating. A reduction of the severity of some of these symptoms would benefit the patient by enhancing quality of life and improving their treatment. Forty-eight patients (25 female and 23 male; mean age 63 +/- 11 years) with a minimum two-week history of cancer-associated gastrointestinal symptoms were assigned to a single, open-label treatment group and received controlled-release metoclopramide 20 mg-80 mg q12h for a maximum period of 12 weeks (mean 46 +/- 35 days). There was a 40%-60% decrease in the severity of nausea over the first two weeks of treatment, and an approximate 50% reduction in severity of vomiting over the first four weeks of treatment. Appetite and bloating also improved, although smaller and less consistent changes were observed. Patient ratings of overall clinical effectiveness with respect to relief from symptoms and tolerability of side effects indicated that controlled-release metoclopramide was highly and moderately effective in 36% and 30% of the patients, respectively. Controlled-release metoclopramide is a useful treatment for the management of gastrointestinal symptoms associated with the cancer-associated dyspepsia syndrome including nausea, vomiting, loss of appetite, and bloating.

System Dynamics Modeling as a Potentially Useful Tool in Analyzing Mitigation Strategies to Reduce Overdose Deaths Associated with Pharmaceutical Opioid Treatment of Chronic Pain

Abstract: Objective. To illustrate a system-level, simulation- based approach for evaluating mitigation strategies to address the dramatic rise in abuse, addiction, and overdose deaths associated with the use of pharma- ceutical opioid analgesics to treat chronic pain. Simulated Interventions. Making available drug for- mulations with increased tamper-resistance, pre- scriber education programs, and programs that reduce rates of medical user-related abuse and addiction. Simulated Outcome Measure. Number of overdose deaths of medical users of pharmaceutical opioid analgesics, including those who abuse or have become addicted. Methods. A demonstration system dynamics model is developed, tested, and used to evaluate the impact of candidate mitigation strategies on the outcome measures. Results. Tamper-resistant drug products will likely reduce overdose death rates but may not reduce overall deaths if there is increased prescribing. Pre- scriber education would likely reduce deaths through a reduction in patient access to pharmaceu- tical opioid analgesics. Conclusions. The system dynamics approach may have potential for opioid-related policy evaluation. However, metrics must be carefully selected, and trade-offs may be involved. For example, it may be difficult to limit negative outcomes associated with pharmaceutical opioids without adversely affecting chronic pain patients' access to pharmaceutical treatment. Ultimately, a combination of metrics and value judgments will be needed to properly evaluate mitigation strategies.

Comparison of abuse, suspected suicidal intent, and fatalities related to the 7-day buprenorphine transdermal patch versus other opioid analgesics in the National Poison Data System.

Abstract: Objective: Prescription opioid related abuse, suicide and death are significant public health problems. This study compares rates of poison center calls categorized as intentional abuse, suspected suicidal intent or fatality for the 7-day buprenorphine transdermal system/patch (BTDS) with other extended-release and long-acting (ER/LA) opioids indicated for chronic pain.Methods: Retrospective 24-month cohort study using National Poison Data System data from July 2012 through June 2014. BTDS was introduced in the United States in January 2011. Numbers and rates of calls of intentional abuse, suspected suicidal intent and fatalities were evaluated for BTDS, ER morphine, ER oxycodone, fentanyl patch, ER oxymorphone and methadone tablets/capsules, using prescription adjustment to account for community availability. Rate ratios (RR) and 95% confidence intervals (CI) were calculated.Results: Absolute numbers and prescription-adjusted rates of intentional abuse and suspected suicidal intent with BTDS were...

Efficacy and Safety of PRC-063, Extended-Release Multilayer Methylphenidate in Adults with ADHD Including 6-Month Open-Label Extension.

Abstract: Objective: To evaluate the efficacy and safety of a 16-hr multilayer-release methylphenidate (PRC-063) in a community-based adult ADHD population. Method: In a double-blind study, 375 participants were randomized to one of four fixed doses of PRC-063 or placebo. The primary outcome was the ADHD-Rating Scale-5 (RS). The first 50% of double-blind completers were invited to participate in a 6-month dose-optimized open-label study to assess response and safety. Results: In total, 333 participants completed the double-blind trial; 184 entered the open-label study. PRC-063 produced greater symptom reduction in ADHD-RS-5 total score from baseline compared with placebo in the double-blind study (least-square [LS] mean = -4.7 [-7.7, -1.6], p = .003). The most frequent adverse events were headache, insomnia, and decreased appetite. No significant sleep quality impact was observed (p = .123). Significant improvements in ADHD-RS-5 scores from baseline continued through the open-label study (p < .0001), coincident with dose optimization. Conclusion: PRC-063 was well tolerated and significantly improved ADHD symptomatology in adults.