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Explore This IssueMay 2014
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The oral anticoagulant apixaban (Elquis) has received an additional indication from the Food and Drug Administration (FDA) for deep vein thrombosis (DVT) prophylaxis in patients who have undergone hip or knee replacement surgery.1 This oral Factor Xa inhibitor is dosed twice daily and requires no routine laboratory (coagulation) testing. To gain approval, more than 11,000 patients were evaluated in comparison to enoxaparin use. The FDA is also reviewing data on apixaban for treating DVT and pulmonary embolism (PE), as well as to reduce the DVT and PE risk. These decisions are expected by August 2014.
Apremilast 30 mg tablets (Otezla) have been FDA approved for treating adult patients with active psoriatic arthritis.2 Apremilast is an oral phosphodiesterase 4 (PDE4) inhibitor specific for cyclic adenosine monophosphate, and it’s the first oral treatment approved by the FDA for psoriatic arthritis. Patients should be monitored for significant weight loss and the development of depression, which may necessitate medication discontinuation. When apremilast is given concomitantly with strong cytochrome P450 (CYP450) inducers, such as phenytoin, carbamazepine, phenobarbital or rifampin, loss of efficacy may occur due to metabolism of the agent. Therefore, it’s not recommended to co-administer strong CYP450 inducers with apremilast. Adverse reactions that occurred in clinical trials more commonly than with placebos included diarrhea, vomiting, upper respiratory infection, nasopharyngitis, headache and upper abdominal pain. The FDA is reviewing apremilast data for treating psoriasis, with a decision expected by September 2014.3
Hyaluronic acid (HA) injection (Monovisc) has been FDA approved as the first single-injection HA product from a non-animal source.4 It is approved to improve joint mobility and pain in patients with osteoarthritis (OA) of the knee.
Methotrexate (Otrexup) for subcutaneous injection, mentioned in the January issue of this column, is now available as a single-dose disposable auto-injector pen for once-weekly administration.5 The product was approved in October 2013 for treating patients with severe, active rheumatoid arthritis (RA) who have not adequately responded to full-dose nonsteroidal antiinflammatory agents. Additional approvals are to treat children with active polyarticular juvenile idiopathic arthritis and to control symptoms of severe recalcitrant, disabling psoriasis in adults who have not adequately responded to other therapies. Otrexup is available as a 0.4 mL injection, in the following strengths: 10 mg, 15 mg, 20 mg and 25 mg.
The generic of Avelox 400 mg tablets, moxifloxacin, is now available.6
Oxycodone hydrochloride/acetaminophen (Xartemis XR) extended-release tablets have been approved by the FDA for managing acute pain severe enough to require opioid therapy and for patients who have had an inadequate response to other therapies or who have not tolerated other therapies.7 This proprietary formulation of oxycodone and acetaminophen includes both immediate- and extended-release components, which are formulated to provide a quick onset of pain relief in less than one hour and to also allow for twice-daily dosing. The current product labeling does not include abuse-deterrent language; however, the manufacturer is working closely with the FDA to develop more data to characterize abuse-deterrence features of the formulation. The manufacturer is also conducting additional studies and will provide this data when it is available.
Tanezumab is an intravenous monoclonal antibody that targets nerve growth factor.8 It’s a selective neurotrophin nerve growth factor mediator, in phase 3 clinical trials for treating pain conditions, including osteoarthritis (OA). In 2010, the FDA placed a partial clinical hold on the agent due to numerous case reports of suspected osteonecrosis that necessitated total joint replacements. A subsequent data review determined that of all the “potential” cases, only two were truly osteonecrosis. In August 2012, the FDA lifted the “partial clinical hold” but placed a new one in December 2012 due to peripheral nervous system effects observed in animals. The tanezumab program is currently subject to a partial clinical hold by the FDA, pending submission of additional nonclinical data. The manufacturer is planning to continue developing the agent for treating OA, chronic low back pain and cancer pain.
A supplemental New Drug Application (sNDA) has been FDA approved for tofacitinib citrate 5 mg tablets, which includes radiographic data from two phase 3 studies in patients with RA. Reduction of radiographic progression was noted in the six-month ORAL Scan (Study IV; 5 mg BID or 10 mg BID tofacitinib) and ORAL Start (Study VI) studies.9 In Study IV, 74% MTX plus placebo tofacitinib-treated patients had no radiographic progression at Month 6, while 84% of tofacitinib 5 mg twice daily (BID) plus MTX-treated patients had no radiographic progression at Month 6. Patients who received tofacitinib 10 mg BID had similar results (79% had no mean progression of structural damage). In the ORAL Start study, 55% of MTX-treated patients had no radiographic progression at Month 6, while 73% of tofacitinib 5 mg BID plus MTX-treated patients had no radiographic progression at Month 6, which was sustained to Month 12. The primary end point was the mean change from baseline in modified total sharp score (mTSS) at Month 6. Tofacitinib is only FDA approved at the 5 mg BID dosage or 5 mg daily in patients with severe renal or hepatic impairment.
Michele B Kaufman, PharmD, CGP, RPh, is a freelance medical writer based in New York City, a Pharmacist at New York Presbyterian—Lower Manhattan Hospital, and Adjunct Faculty at Touro College of Pharmacy, New York City.
- Barber J. FDA expands approval of Pfizer, Bristol-Myers Squibb’s Eliquis for DVT prevention after hip or knee replacement surgery. Published March 14, 2014 (last accessed April 3, 2014). http://www.firstwordpharma.com/node/1195709#axzz2xBXvoSaG.
- Adding multi-media materials: Otezla (apremilast)—First oral therapy approved by the U.S. Food and Drug Administration for the treatment of adults with active psoriatic arthritis. Published March 24, 2014 (last accessed April 3, 2014). http://ir.celgene.com/releasedetail.cfm?ReleaseID=835117.
- Berkrot B. FDA approves Celgene drug for psoriatic arthritis. Published March 21, 2014 (last accessed April 3, 2014). http://health.yahoo.net/news/s/nm/fda-approves-celgene-drug-for-psoriatic-arthritis.
- FDA approves MONOVISC, a new single injection treatment for treatment of pain due to osteoarthritis of the knee. Published Feb. 25, 2014 (last accessed April 3, 2014). http://ir.anikatherapeutics.com/releasedetail.cfm?ReleaseID=828235.
- Otrexup injection launched for RA, psoriasis. Published Jan. 15, 2014 (last accessed April 3, 2014). http://www.empr.com/otrexup-injection-launched-for-ra-psoriasis/article/329429.
- Teva announces availability of moxifloxacin hydrochloride tablets. Published Feb. 20, 2014 (last accessed April 3, 2014). http://www.drugstorenews.com/article/teva-announces-availability-moxifloxacin-hydrochloride-tablets.
- Mallinckrodt plc receives FDA approval for XARTEMIS XR (oxycodone hydrochloride and acetaminophen) extended-release tablets (CII). Published March 12, 2014 (last accessed April 3, 2014). http://phx.corporate-ir.net/phoenix.zhtml?c=251847&p=RssLanding&cat=news&id=1908261.
- Walsh N. Tanezumab eases OA pain, safety still an issue. Published March 18, 2014 (last accessed April 3, 2014). http://www.medpagetoday.com/Rheumatology/Arthritis/44822.
- Pfizer announces FDA approval to include radiographic data on reduction of progression of structural joint damage for adults with moderately to severely active rheumatoid arthritis in labeling for XELJANZ (tofacitinib citrate). Published Feb. 24, 2014 (last accessed April 3, 2014). http://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_fda_approval_to_include_radiographic_data_on_reduction_of_progression_of_structural_joint_damage_for_adults_with_moderately_to_severely_active_rheumatoid_arthritis_in_labeling_for_xeljanz_tofacitinib_citrate.