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...(potential prescription opioid abuse pati...),Health

Date:5/8/2008

potential prescription opioid abuse, patients and physicians may be reluctant to initiate opioid therapy for pain relief(4B) and, therefore, there is a need for products that deliver effective pain relief while minimizing the potential for misuse, abuse and diversion.(3B,7)

Study Findings

The first study, a Phase I randomized, double-blind, 4-way crossover trial, compared the effects of ALO-01 (2x 60 mg capsules), when taken whole as intended, against ALO-01 crushed and taken orally, immediate-release morphine sulfate solution (120 mg) and placebo capsules. Participants were healthy adults (N=32) who were not currently physically opioid-dependent but had used opioids to attain non-medical effects on at least 10 occasions during the past year and at least once in the 12 weeks before the study. Study participants sequentially received the four treatments, administered in a randomized, double-blinded fashion, with each treatment separated by a 14-21 day washout period.

Following each treatment, participants assessed drug liking, feeling high, good and bad effects using a visual analog scale (VAS) and completed questionnaires designed to rate abuse potential, stimulation/euphoria and subjective drug value. In addition, plasma levels of both morphine and naltrexone were measured pre-dose and at specified intervals up to 24 hours after each treatment.

Scores for drug liking, feeling high, and good effects were similar for ALO-01 crushed compared to ALO-01 whole (68.1 to 67.6, 55.0 to 60.6 and 52.1 to 59.4, respectively). These scores were significantly higher for morphine sulfate solution (89.5, 90.4 and 89.7, respectively, p less than or equal to 0.002), and peaked sharply around 1.5 hours after exposure, consistent with the time of maximum plasma levels for immediate-release morphine. Scores for stimulation/euphoria, abuse potential and subjective drug value were also similar for ALO-01 crushed and whole, but were significantly higher for mo
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