King Pharmaceuticals, Inc reported results from its phase-III 12-month open-label safety and efficacy study evaluating Embeda (morphine sulfate and naltrexone hydrochloride) Extended Release capsules.
The results were presented in a poster session (abstract #229) at the American Academy of Pain Medicine's 25th Annual Meeting in Honolulu, HI.
The results showed that Embeda provided continued pain relief for up to 12 months in opioid-tolerant patients with chronic, moderate to severe, non-malignant pain. Findings also showed that Embeda was safe and well-tolerated for long-term chronic pain therapy.
Embeda is a long-acting Schedule II opioid analgesic that King is developing in response to the need for opioid analgesics that have the potential to reduce the risk of misuse and abuse. Utilizing King's proprietary technology, Embeda contains extended-release morphine pellets, each with a sequestered core of naltrexone, an opioid antagonist. The formulation is designed to work such that if taken as directed, the morphine would relieve pain while the sequestered naltrexone would pass through the body with no intended clinical effect. If Embeda pellets are chewed or crushed, naltrexone is released and rapidly absorbed, reducing the feeling of drug liking and euphoria. This means Embeda may reduce misuse or abuse when tampered with by crushing or chewing.
The secondary efficacy findings from the study demonstrated that patients who were taking Embeda reported significant decreases in pain, as measured by the weekly Brief Pain Inventory (BPI) Average Pain Intensity Score from the start of the study to the 52-week endpoint. Additionally, 90 percent of evaluable patients assessed Embeda as good, very good or excellent from baseline to endpoint.
"This clinical study showed that Embeda continued to effectively decrease pain over a period of 12 months in chronic pain patients," said Dr Eric Carter, chief science officer of King Pharmaceuticals. "These results, along with earlier safety and efficacy findings, demonstrate that Embeda has the potential to be one of the first formulations designed to deter common methods of misuse and abuse, while safely and effectively treating patients with chronic pain."
The Embeda New Drug Application (NDA) was submitted in June 2008 and is currently under review by the US Food and Drug Administration (FDA).
Embeda is an Investigational New Drug currently under review by the FDA and has a proposed indication for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Embeda is an extended-release form of morphine intended for once or twice daily dosing.