King Pharmaceuticals (King) has received FDA approval for Embeda (morphine sulfate and naltrexone hydrochloride) extended release capsules for oral use.
Embeda, a long-acting opioid that is designed to reduce drug liking and euphoria when tampered with by crushing or chewing.
The FDA approval was based on data from 12 clinical studies of Embeda, including phase III data demonstrating efficacy and safety.
In a phase III study, Embeda provided significant pain relief in patients with moderate to severe pain due to osteoarthritis of the hip or knee, as compared to placebo.
Brian Markison, chairman, president and CEO of King, said: Today’s approval of Embeda marks a milestone in pain care, and King is proud to bring this new technology to the US market. King is committed to providing resources and medicines to patients and healthcare professionals to achieve optimal pain control. We are focused on developing medicines that use novel technologies designed to reduce drug liking and make it more difficult to extract the active ingredient. We anticipate a September 2009 launch for Embeda.
In addition to Embeda, King is developing a portfolio of long- and short-acting opioid pain medications and technologies that are designed to offer treatment while reducing potential risks of unintended uses. We believe that we could treat a wide range of patients with products designed to address this important societal issue, he added.