King Pharmaceuticals reports positive results from pain trial

King Pharmaceuticals has reported positive results from its Phase III 12-month open-label safety and efficacy study evaluating Embeda extended release capsules.

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.

The secondary efficacy findings from the study demonstrated that patients who were taking Embeda reported significant decreases in pain, as measured by the Brief Pain Inventory average pain intensity score from the start of the study to the 52-week endpoint. Additionally, 90% of evaluable patients assessed Embeda as good, very good or excellent from baseline to endpoint.

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. The Embeda new drug application was submitted in June 2008 and is currently under review by the FDA.

Eric Carter, chief science officer of King Pharmaceuticals, said: This clinical study showed that Embeda continued to effectively decrease pain over a period of 12 months in chronic pain patients. 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.