FDA to Discuss Alpharma Morphine Pill

WASHINGTON (AP) - The Food and Drug Administration is slated Friday to discuss an experimental morphine pill from Alpharma(ALO) that is designed to discourage abuse.

Alpharma has asked the FDA to approve Embeda as a tamperproof medication for patients with moderate to severe chronic pain. The pill is formulated so that the euphoric effects of morphine are blocked when a patient crushes, dissolves or chews them. Patients often abuse pain pills by grinding them up to snort or inject.

The FDA on Friday will ask a panel of outside advisers how effective Embeda is likely to be at discouraging such abuse.

Embeda contains morphine along with an antagonist, a drug that neutralizes the effects of the narcotic when it is used inappropriately. However, FDA reviewers questioned whether exposing patients to low levels of the antagonist might cause safety problems.

In its own studies, Alpharma said the most common side effects associated with the antagonist were nausea and vomiting.

Cowen and Co. analyst Ian Sanderson wrote in a research note earlier this week that the FDA's review documents seemed favorable, and he expected a positive ruling from panelists on Friday. The agency is mainly looking to the panel for "advice on label language and risk management plan design," he wrote.

If Embeda is approved, it would help offset lost sales from Alpharma's morphine drug Kadian, which is expected to lose patent protection in 2010. The drug was Alpharma's best-selling product last year with sales of $167.7 million.

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