While the initial new drug application (NDA) submission qualified for a priority review, certain technical issues around data presentation prevented a complete evaluation by the FDA within the six month time period permissible for a priority review. The company expects to address the submission issues and re-qualify for priority review in its resubmission. Alpharma is fully committed to collaborating with the FDA to complete a timely review of the Embeda NDA, and continues to anticipate a first quarter 2009 launch following approval.
Embeda (morphine sulfate extended-release with sequestered naltrexone hydrochloride) was developed with Alpharma’s proprietary technology, which combines an extended release opioid with sequestered naltrexone, an opioid antagonist. In clinical trials, when Embeda was taken as directed, it provided effective pain relief and the sequestered naltrexone passed through the body without effect.