The FDA has approved Embeda (morphine sulfate and naltrexone HCl extended-release capsules, from King Pharmaceuticals), for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
This approval was based on data from twelve Phase 2 and 3 clinical studies that demonstrated Embeda to provide significant pain relief in patients with moderate to severe pain due to osteoarthritis of the hip or knee compared to placebo and to be bioequivalent to another marketed extended-release morphine capsule product.
Embeda is designed to reduce drug liking and euphoria when tampered with by crushing or chewing. Utilizing King’s proprietary technology, Embeda contains extended-release morphine pellets, a long-acting opioid analgesic, each with an inner core of naltrexone, an opioid receptor antagonist. When taken as directed, the sequestered naltrexone passes through the body with no intended clinical effect. If crushed or chewed, Embeda releases the naltrexone to reduce the subjective and analgesic effects of morphine. The clinical significance of the degree of this reduction has not been established, and there is no evidence that the naltrexone reduces the abuse liability of Embeda.
Embeda is a C-II controlled substance. It will be available in September 2009 in six fixed-dose combination capsules containing morphine sulfate and sequestered naltrexone HCl: 20mg/0.8mg, 30mg/1.2mg, 50mg/2mg, 60mg/2.4mg, 80mg/3.2mg, and 100mg/4mg.
For more information call (800) 776-3637 or visit www.embeda.com.