Alpharma withdraws NDA for Embeda

BRIDGEWATER, N.J. Alpharma has announced that it has withdrawn its application for its chronic pain opioid drug Embeda with the Food and Drug Administration. The company, though, plans to resubmit a revised application as soon as possible.

The initial application was submitted on Feb. 28 and qualified for a priority review but, certain technical issues around data presentation prevented a complete evaluation by the FDA within the six-month time period permissible for a priority review.

Alpharma continues to anticipate a first quarter 2009 launch following approval.

Embeda was developed by combining an extended release opioid with sequestered naltrexone, which is used to block the euphoric effects of the drug when taken incorrectly. When the Embeda capsule was crushed, chewed or dissolved, which are common approaches abusers use to tamper with the product in order to gain euphoria, the naltrexone was released thereby significantly reducing the euphoric effect of the opioid.