Information on New Drug Approvals and Medication Safety

Oxymorphone extended-release (Opana ER) was FDA approved in December 2011 to treat adults with around-the-clock, moderate to severe pain expected to last for an extended time.^13,14 Oxymorphone ER is not for “as-needed pain” and is now crush-resistant to prevent tampering. However, any tablet alteration could result in potential overdose or death. This year, the manufacturer, Endo Pharmaceuticals, plans on transitioning from the older formulation to this new formulation. Both formulations will look alike with similar packaging and tablet color and identification.

Rivaroxaban (Xarelto), a new oral anti-Xa inhibitor that recently received FDA approval, is seeking another indication, that of treatment of acute coronary syndrome. Currently, rivaroxaban is FDA approved for the prophylaxis of deep vein thrombosis that may lead to pulmonary embolism in patients undergoing knee or hip replacement surgery and for treating atrial fibrillation.¹⁵

Ruxolitinib is the first JAK inhibitor to be FDA approved. This agent was approved on November 16, 2011 to treat the orphan bone marrow disease myelofibrosis.¹⁶ This agent is similar in mechanism to tofacitinib that is currently being reviewed at the FDA, except that this agent inhibits JAK-1 and JAK-2 enzymes. These kinases are also responsible for causing anemia, splenomegaly, nights sweats, and joint and bone pain. Patients in these clinical trials received ruloxitinib, placebo, or conventional therapy consisting of chemotherapy, hydroxyurea, or corticosteroids. The agent is taken orally twice daily.

Tocilizumab has been recommended by the National Institute and Clinical Excellence final guidance for reimbursement to the National Health Service in Great Britain for use in young patients two years of age and older with systemic juvenile idiopathic arthritis (SJIA) where prior therapies have not yielded a satisfactory response.¹⁷ It is not recommended for patients whose disease has not been treated with MTX or patients who are responding to MTX. In August, tocilizumab was approved in Europe for use in patients two years of age and older with SJIA, but who have not satisfactorily responded to prior therapy with nonsteroidal antiinflammatory agents and systemic steroids.

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Krystexxa (pegloticase) REMS. Available at www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM227955.pdf. Accessed February 14, 2012.
2. Methotrexate IV updated label. Available at www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011719s117ltr.pdf. Published September 1, 2011. Accessed February 3, 2012.
3. American Society of Health-Systems Pharmacists REMS Resource Center. Available at www.ashp.org/menu/PracticePolicy/ResourceCenters/REMS.aspx. Accessed January 27, 2012.
4. BCX4208 (PNP Inhibitor). Available at www.biocryst.com/bcx_4208. Accessed January 30, 2012.
5. Rigel. More than 2 million suffer from rheumatoid arthritis. Available at www.rigel.com/rigel/rheumatoid_arthritis. Accessed February 14, 2012.
6. Rigel. Rigel earns milestone payments from AstraZeneca Fostamatinib (R788) enters phase 3 clinical program. Available at http://ir.rigel.com/phoenix.zhtml?c=120936&p=irol-newsArticle&ID=1475814&highlight=. Published September 29, 2010. Accessed January 30, 2012.
7. Fostamatinib trials. Available at www.clinicaltrials.gov/ct2/results?term=oskira. Updated January 11, 2012. Accessed January 30, 2012.
8. Sarilumab/REGN88 (IL-6R Antibody). Available at www.regeneron.com/regn88. Published 2012. Accessed January 31, 2012.
9. Positive phase 2b results with sarilumab in rheumatoid arthritis to be presented as a late-breaking poster at the 2011 American College of Rheumatology Annual Meeting. Available at http://newsroom.regeneron.com/releasedetail.cfm?releaseid=618491. Published October 27, 2011. Accessed January 31, 2012.
10. Medical News. FDA accepts Pfizer’s tofacitinib NDA for review. Available at www.news-medical.net/news/20111221/FDA-accepts-Pfizers-tofacitinib-NDA-for-review.aspx. Published December 21, 2011. Accessed January 31, 2012.
11. Walsh N, Agus ZS. ACR: RA patients improved markedly on tofacitinib. Available at www.medpagetoday.com/MeetingCoverage/ACRMeeting/29619. Published November 11, 2011. Accessed January 31, 2012.
12. Nelson R. FDA approves glucarpidase to reduce toxic methotrexate levels. Available at www.medscape.com/viewarticle/757023?sssdmh=dm1.751129&src=nl_newsalert. Published January 17, 2012. Accessed January 31, 2012.
13. FDA approves Endo Pharmaceuticals’ crush-resistant Opana ER. Available at http://online.wsj.com/article/BT-CO-20111212-706944.html?mod=dist_smartbrief. Published December 12, 2011. Accessed December 13, 2011.
14. Opana ER Extended-Release tablets. Available at www.drugs.com/cdi/opana-er-extended-release-tablets.html. Accessed February 3, 2012.
15. Xarelto: Highlights of prescribing information. Available at www.accessdata.fda.gov/drugsatfda_docs/label/2011/022406s000lbl.pdf. Published July 1, 2011. Accessed January 31, 2012.
16. Jefferson E. FDA approves first drug to treat a rare bone marrow disease. Available at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm280102.htm. Published November 16, 2011. Accessed February 2, 2012.
17. Dennis M. Roche’s RoActemra backed by NICE for some with juvenile arthritis. Available at www.firstwordpharma.com/print/934701?tsid=17. Published December 14, 2011. Accessed December 14, 2011.