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Remoxy is a long acting oral formulation of oxycodone intended to treat moderate-to-severe pain, and designed to reduce risks of unintended use. The drug is being developed by Pain Therapeutics under license from Durect Corp. (DRRX), and Pain Therapeutics in turn has sublicensed the commercialization rights of Remoxy to King Pharma.

According to King Pharma, Remoxy is designed to resist common methods of prescription drug misuse and abuse. The company believes the rate-limiting step is the generation of six-month stability data, and no new clinical trials are required. King remains committed to the development and commercialization of Remoxy, and said it would work closely with the FDA toward approval of the product.

The new drug application for Remoxy was submitted in June 2008. An FDA panel, which reviewed Remoxy last November, had a mixed view about the drug - with some members concluding that Remoxy is less susceptible to abuse than other pain killers and some members ruling that the drug may be not so tamper resistant.

The FDA, however, issued a complete response letter for Remoxy last December and requested additional non-clinical data to support the drug's approval.

KG is currently trading at $9.40, down 10 cents or 1.05%. PTIE is currently trading at $4.55, down 93 cents or 16.97%.

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