King Feels The Pain Of An FDA Delay
Make a commentBy Ed Silverman // December 11th, 2008 // 3:37 pm
The drugmaker was handed a setback today after the agency asked for more data before approving Remoxy, one of the first painkillers designed to prevent abuse. The FDA “believes additional non- clinical data will be required to support the approval,” according to a King statement.
The request for non-clinical data may likely refer to the wording on product labeling, and King wants to be able to market Remoxy as “abuse deterrent.” Remoxy is a version of oxycodone, and comes in a time-release gel capsule that can’t be crushed or chewed and doesn’t dissolve in liquid. King hopes to grab market share from Purdue Pharma, which sells OxyContin.
King stock dropped on the news, but Corey Davis, an analyst at Natixis Bleichroeder, tells Bloomberg News that investors are overreacting. “It’s extremely encouraging” the FDA didn’t request new studies in people. “This should be a very quick turnaround and still allow them to launch the drug by the second quarter of 2009.”
Meanwhile, King is paying $1.6 billion to acquire Alpharma, which is also pursuing the approval of an abuse-deterrent pain medication called Embeda.
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Alpharma, King Pharmaceuticals, OxyContin, Purdue Pharma, Remoxy