UPDATE 2-King, Pain Therapeutics may refile Remoxy in 2010
* New timeline comes after FDA meeting
* Remoxy pain drug designed to thwart abuse
* King shares fall 0.5 pct; Pain Thera drops 6.9 pct (Adds background, analyst comment, shares)
NEW YORK, July 7 (Reuters) - King Pharmaceuticals Inc (KG.N) and Pain Therapeutics Inc (PTIE.O) said on Tuesday they may not resubmit the application for their experimental pain drug Remoxy until the middle of next year.
The companies outlined the new timeline after King met last week with the U.S. Food and Drug Administration to discuss the application for Remoxy. The agency initially declined to approve Remoxy in December.
King shares slipped 0.5 percent to $9.45, while Pain Therapeutics' shares fell 6.9 percent to $5.10.
The timing of the refiling depends on when the company can gather data demonstrating Remoxy's stability, said King, which believes no new clinical trials are required.
"King now anticipates the resubmission of the (application) could occur mid-year 2010," the company said in a statement.
Remoxy is a long-acting version of the potent oxycodone painkiller. The experimental drug is designed to thwart potential abuse.
BMO Capital Markets analyst Robert Hazlett said the drug appears to be on track for a 2011 approval. Such timing could pave the way for competing products to reach the market ahead of Remoxy, Hazlett said in a research note, "limiting the King product's appeal."
Bristol, Tennessee-based King is counting on Remoxy to help it become a leader in the field of abuse-resistant painkillers, which it hopes will offset slower sales of drugs such as its Altace blood pressure medicine.
But winning U.S. approval for such drugs has been a struggle. The FDA last week denied approval of Acurox, which King developed with Acura Pharmaceuticals Inc (ACUR.O). King is awaiting a decision from the FDA on its Embeda pain drug, which King acquired as part of its $1.6 billion deal for drugmaker Alpharma.
"Long-term prospects for the company appear to be improving but are dependent upon meaningful progress with the abuse resistant opioid opportunities," Hazlett said. (Reporting by Lewis Krauskopf; Editing by Derek Caney and Maureen Bavdek)
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