SAN FRANCISCO (Dow Jones) - The U.S. Food and Drug Administration said it cannot approve a pain drug called Remoxy that is being developed by King Pharmaceutcicals and Pain Therapeutics.
Shares of Pain Therapeutics (PTIE) plunged more than 20% to $6.19 on the news Thursday morning. King (KG) shares were off 6% at $9.36.
In a letter to the companies, the FDA said it believes "additional non- clinical data" will be required to support the approval of the drug, which is designed as an abuse-resistant form of the popular pain drug oxycodone. The companies said the agency has not requested or recommended additional clinical efficacy studies prior to approval.
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