Sunday, January 1, 2012

Jan 2012 – Pain Product Announcements & Warnings

Pain Product Announcements Featured Items: extended-release oxymorphone (Opana ER) FDA approved in crush-resistant formulation; first-time generic FDA approval of morphine sulfate ER (Kadian equivalent). — All brand names are trademarks of their respective manufacturers. Compiled by: Winnie Dawson, MA, RN, BSN.

Extended-Release Oxymorphone (Opana ER®) — New Crush-Resistant Formulation FDA Approved
The U.S. Food and Drug Administration granted a December 2011 approval of Endo Pharmaceutical’s crush-resistant formulation of Opana ER. The decision indicates that an FDA evaluation found no significant difference in the efficacy and safety of the crush-resistant product when compared with the original Opana ER tablets approved in June, 2006. Opana ER is a Schedule II controlled substance designed to provide consistent delivery of oxymorphone over a 12-hour period to appropriate patients who need around-the-clock analgesia. Endo reports that the company plans to retain the name Opana ER and replace the 7 dosage strengths of the current formulation with the new crush-resistant product — intended to reduce abuse potential — during 2012. See Opana ER prescribing information [here] for administration and safety instructions, and [here] for the patient Medication Guide.

Morphine Sulfate ER (Kadian® equivalent) — First-time Generic FDA Approval
Watson Pharmaceuticals announced a December 2011 FDA approval of their generic morphine sulfate extended-release capsules — a formulation equivalent to the brand drug Kadian. This Schedule II controlled drug is indicated for the management of moderate to severe pain in patients who need continuous pain relief. A related news story (PRNewswire) reported that Watson has already started shipping the product in the following strengths: 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, and 100 mg. Read the prescribing information [here] for administration instructions and capsule descriptions.