King and Pain Therapeutics see slight FDA setback (KG, PTIE, DRRX)
King Pharmaceuticals (KG) and Pain Therapeutics (PTIE) on Tuesday said they expect to resubmit their new drug application for their controlled-release oxycodone pain medication called Remoxy in mid-2010, slightly later than anticipated.
There was a hope, if not an expectation, after a meeting last week that the FDA might allow the drug to come to market a bit faster by maintaining tight control of the number of patients that could get a prescription for it, and the desire to get a product in the market that may reduce the risk of illegal oxycodone use.
King in a press release said last week’s meeting gave the company a “clear path forward” to resubmit the new drug application for Remoxy. As anticipated, the company will have to generate six-month stability data. No new clinical trials are required.
The news is likely to be seen as a slight disappointment for King, which has seen a flurry of FDA-related announcements in recent weeks, including an FDA-imposed delay in bringing an immediate-release version of oxycodone to the market called Acurox.
Next up is an FDA Advisory Committee review of its drug CorVue, expected later this month, which is meant to allow stress imaging tests for coronary artery disease patients who can’t perform a heart stress test.
This morning’s announcement on Remoxy may also affect shares of Durect Corp (Nasdaq: DRRX), as the formulation is partly based on Durect’s Oradur sustained-release technology. — Mike Tarsala
