Alpharma Presents Data Addressing Abuse Liability Features, Safety and Efficacy on ALO-01 (EMBEDA(TM)) (morphine sulfate extended-release with sequestered naltrexone hydrochloride) at the American Pain Society Annual Scientif...(rphine sulfate solution. Plasma levels o...),Health

Date:5/8/2008

rphine sulfate solution. Plasma levels of morphine and time to maximum concentration for ALO-01 crushed (80.6 ng/mL, 1.1 hrs) were similar to morphine sulfate solution (92.5 ng/mL, 1.2 hrs), while significantly lower (19.3 ng/mL) and longer (8.1 hrs) for ALO-01 whole. For ALO-01 crushed, naltrexone levels reached a peak concentration (1.1 hrs) at a time similar to morphine; for ALO-01 whole, naltrexone was not detected or was present in only trace amounts. Adverse events were mostly mild to moderate. The most common adverse events during treatment were euphoria (28.1 percent and 56.3 percent), pruritus or itching (28.1 percent and 53.1 percent) and somnolence or drowsiness (43.8 percent and 34.4 percent) for ALO-01 whole and morphine sulfate solution, respectively.

The second study, a randomized, double-blind, crossover Phase II trial, compared the effects of ALO-01 taken whole (intact orally) with an extended-release morphine sulfate formulation not containing naltrexone in 113 patients with moderate to severe pain due to osteoarthritis of the hip or knee. Patients had required treatment of the affected joint with non-opioid analgesics or had received the equivalent of less than or equal to 40 mg/day of oral morphine sulfate. After an initial washout period from previous medications until a pain flare (scored greater than or equal to 5 on a scale of 1-10) occurred, patients were titrated on extended-release morphine sulfate open-label until their pain subsided (scored less than or equal to 3) for a minimum of four consecutive days with no unacceptable adverse events. Qualified patients were then randomized to receive either ALO-01 or extended- release morphine sulfate double-blinded during two 14-day treatment periods, each followed by a seven-day open label period on extended morphine sulfate, all at the dose established in the titration period.

Efficacy assessments conducted during the study included continuing in-clinic pain intensity ratings; dail
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