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news.Alpharma has received clearance from the FDA to begin a phase II clinical efficacy trial for an abuse-resistant, extended-release opioid designed to treat chronic pain.
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The drug is being developed for the treatment of chronic moderate-to-severe malignant (cancer-related) and non-malignant pain, such as osteoarthritis and lower-back.
Alpharma has developed a proprietary technology that combines an extended- release opioid with an antagonist in a single dosage form. If the dosage form is tampered with by crushing, chewing, or dissolving, the antagonist would be released, thereby abating the effects of the opioid, including euphoria.
Abuse of pain products is a key concern of physicians; there are currently no US extended-release opioid pain products formulated that can successfully address the issue of abuse.
However, Alpharma hopes their product will overcome such fears. Dr Ronald Warner, president of Alpharma branded products division said; “We believe this formulation will considerably alleviate these concerns, resulting in improved treatment of patients with chronic pain, and expanding the opioid chronic pain market, which already exceeds $3 billion annually.”