Elite Pharmaceuticals Inc (ELTP)

[Hike]

Painful damage as Remoxy is rejected again (Subscription Only Story)

Source: EP Vantage
Company: Pain Therapeutics, DURECT, Pfizer
Date: June 24, 2011

Investors in Pain Therapeutics and Durect who took as a positive sign the FDA’s approval of Oxecta last Friday are gnashing their teeth today (Oxecta FDA approval tempered by lack of abuse resistance claim (http://www.epvantage.com/Universal/View.aspx?type=Story&id=248098&isEPVantage=yes) , June 21, 2011). The regulator has rejected the companies' abuse-resistant oxycodone pill Remoxy, causing shares in both to tumble in early trade today.

The second complete response letter raises the spectre of Pfizer pulling the plug on development of the extended-release pain reliever. Such a scenario would leave Texas-based Pain with a tough decision over whether to try a third time for approval of its lead product on its own, or re-focus on its early-stage assets.