ALO-01 (extended-release morphine sulfate plus sequestered naltrexone) showed similar effectiveness to Alpharma’s extended-release oral formulation of morphine sulfate, Kadian, and maintained pain reduction throughout the study. The sequestered naltrexone did not interfere with patients’ pain relief. The majority of patients rated both medications as good, very good or excellent.
ALO-01 is developed with Alpharma’s proprietary technology, which combines an extended-release opioid with sequestered naltrexone, an opioid antagonist. When ALO-01 is taken as directed, it provides pain relief and the naltrexone remains sequestered in the pellet core and passes through the gastrointestinal tract without significant absorption. If the product is crushed, chewed or dissolved, the naltrexone is released and blocks opioid effects, such as euphoria.
Joseph Stauffer, chief medical officer and senior vice president of clinical research & medical affairs, said: “We are pleased with the results of this Phase II trial with ALO-01, which showed our investigational abuse-deterrent product provides similar pain relief and tolerability as our extended-release opioid Kadian.
“Based on these positive findings, we began Phase III trials for ALO-01, which have been fully enrolled, reinforcing our commitment to providing relief to patients with moderate-to-severe chronic pain while helping to reduce the risk of misuse, abuse and diversion.”