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news.Alpharma has announced results from Phase I and II clinical trials that showed ALO-01 capsules demonstrated clinically relevant features addressing abuse liability alongside a promising safety and efficacy profile.
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ALO-01 (Embeda (morphine sulfate extended-release with sequestered naltrexone hydrochloride) is an investigational pharmacologic abuse-deterrent, extended-release opioid that Alpharma is developing for the treatment of moderate to severe chronic pain.
According to Phase I study findings, recreational drug users found crushed ALO-01 to be significantly less desirable than an equivalent dose of immediate release morphine sulfate solution and no more desirable than ALO-01 taken whole. Although study participants had five times higher levels of morphine in their blood after taking crushed ALO-01 (versus intact ALO-01), they reported significantly reduced drug liking, feeling high and good effects, including euphoria, compared to immediate release morphine sulfate solution.
Data presented from a separate Phase II study including patients with moderate to severe chronic pain due to osteoarthritis showed that the efficacy and tolerability of ALO-01 was comparable to marketed extended-release morphine sulfate capsules (Kadian Capsules). Additionally, when ALO-01 was taken as directed, the sequestered naltrexone had no impact on either pain relief or tolerability.