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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

erse event profile was similar to that seen with short-acting oxycodone, and ACUROX(R) was generally well tolerated.

Evaluation of Plasma Naltrexone Concentrations Resulting From Use of ALO-01 (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules for Chronic Pain

EMBEDA(TM) Capsules (ALO-01), a novel opioid formulation, contain pellets of an extended-release formulation of morphine sulfate surrounding an inner core of naltrexone hydrochloride. EMBEDA(TM) is intended to treat moderate to severe chronic pain. This 12 month open-label safety study evaluated the plasma concentrations of naltrexone following use of ALO-01 (morphine sulfate and naltrexone hydrochloride). Samples were drawn to measure plasma concentrations (concs) of morphine (M) naltrexone (N) and its metabolite, 6-beta-naltrexol (6-beta-N) when taken as directed. Results showed that, when ALO-01 was taken as directed, steady state plasma morphine levels remain stable. Naltrexone and 6-beta-N do not accumulate; small amounts, when detected, were not dose related and not associated with clinically observable effects of opioid withdrawal or reduction of pain relief.

Phase II Study to Evaluate the Dose Response for Flushing, Safety and Tolerability of Escalating Doses of Niacin in Fasted and Fed Healthy Adult Volunteers

ACUROX(R) Tablets, with Aversion(R) Technology, are a composition of oxycodone HCl, niacin, and other inactive ingredients. The niacin ingredient can generate a temporary, but increasingly unpleasant effect, including flushing. A Phase II study was conducted to evaluate the dose response for niacin-induced flushing, the effect of food on niacin-induced flushing, and the safety and tolerability of varying doses of niacin. Volunteers were broken into two groups (fed and fasted) and were provided varying doses of niacin to consume over a period of
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SOURCE King Pharmaceuticals, Inc.
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