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King Pharmaceuticals Showcases Data From Pain Pipeline of Medicines Designed to Deter Common Methods of Non-Therapeutic Use
Date:6/25/2009

days. Results demonstrated a niacin dose-response relationship in both fed and fasted volunteers, with niacin being better tolerated in the fed state. Also, the most frequently reported adverse effects (AEs) were those commonly associated with niacin. These findings suggest that niacin will be well tolerated up to 60 mg per dose and will likely be well tolerated at 90 mg per dose.

Phase II Multiple-Dose Study of the Safety and Tolerability of Niacin 30 mg and 60 mg Combined With Oxycodone HCl 5 mg Versus Oxycodone HCl 5 mg Alone in Healthy Adult Volunteers

A Phase II study was conducted to evaluate the safety and tolerability of multiple daily doses of the active components of ACUROX(R) Tablets, and to determine if tolerance to the effects of niacin develops after repeat administration. Three groups of participants received different doses of niacin combined with oxycodone HCl, and the Side Effects and Symptoms Questionnaire (SESQ) and the Niacin Tolerability Rating Scale (TRS) were used to assess niacin tolerability end points. Results showed that approximately 75 percent of all volunteers in all groups rated the tolerability of study drugs as easy to tolerate or as having no effect, and that adverse effects (AEs) were consistent with the known safety profiles of oxycodone and niacin. These findings support the safety and tolerability of niacin in ACUROX(R) Tablets when taken at the recommended dose.

The Interaction Between Opioids and Alcohol: Results from a Global Literature Review

The potential risk for alcohol to interact with drugs and/or disrupt a drug formulation matrix is a prevalent safety concern. For extended-release opioids, there is an added concern that ethanol (EtOH) may disrupt the formulation mechanism leading to increased bioavailability of the opioid. Although the combination of EtOH and prescription opioids is frequently cited as having increased impairing effects, ver
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SOURCE King Pharmaceuticals, Inc.
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