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news.Clinical significance of the degree of reduction in drug liking and euphoria reported in clinical studies has not yet been established
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King Pharmaceuticals has announced the commercial availability for EMBEDA (morphine sulfate and naltrexone hydrochloride) extended release capsules, a long-acting Schedule II opioid analgesic for the management of moderate to severe pain.
King has begun shipments of six dosage strengths (20mg/0.8mg, 30mg/1.2mg, 50mg/2mg, 60mg/2.4mg, 80mg/3.2mg and 100mg/4mg) and is instituting a wholesale and retail stocking program to disseminate this product to retail pharmacies across the US.
However, the clinical significance of the degree of reduction in drug liking and euphoria reported in clinical studies has not yet been established. There is no evidence that the naltrexone in EMBEDA reduces the abuse liability of EMBEDA.
Reportedly, EMBEDA contains morphine pellets, each with an inner core of naltrexone hydrochloride (HCl), an opioid receptor antagonist. If tampered with by crushing or chewing, the naltrexone HCl is released and absorbed with the morphine.
Will Rowe, CEO of the American Pain Foundation, said: “Effective pain management begins by removing barriers and helping patients manage their pain. When used responsibly and monitored regularly, these new technologies may help ease concerns prescribers may have when recommending current standard-of-care opioid treatments-allowing more pain patients to get the care they need.”
The company said that in order to ensure that the benefits of EMBEDA outweigh the potential risks of EMBEDA, King has implemented a Risk Evaluation and Mitigation Strategy (REMS) in response to a requirement of the FDA.