Drug Topics - January 2009 - (Page 26) Issues & Trends NEW DRUGS fibrillation or atrial flutter. Clinical ucts and several agents with new trial results indicate that this agent mechanisms of action are making may be better tolerated than amiotheir way through the approval darone. process. New products to watch for include GlaxoSmith-Kline’s darapladib, which targets lipoprotein-asCentral nervous system sociated phospholipase (Lp-PLA2), Several migraine treatments are and Isis and Genzyme’s mipomersunder investigation, as are new fien, an apolipoprotein B100 antibromyalgia agents. The CNS marsense inhibitor designed as a lipid ket will also see several drugs going reducer for high-risk cardiovascular off patent in 2010 and 2011. patients. Two new cholesteryl ester Existing antidepressants often transfer protein (CETP) inhibitors, have negative side effects, efficacy Merck’s anacetrapib and Roche’s problems, and poor patient compliR1658, are also on the horizon. ance. One drug in the pipeline is There has been a push to develsaredutant (Sanofi-Aventis), a neuop new antiplatelet and antithromrokinin-2 receptor antagonist with botic agents to replace less effeca mechanism of action that blocks tive and more costly products. As the effects of neurokinin-2. mentioned previously, if approved, Melatonin receptor agonists prasugrel, a platelet inhibitor used for the prevention of carare also in the pipeline. An example is agomelatine, now diovascular events in patients with acute coronary syndrome in phase 3 trials. Compared with existing antidepressants, (ACS), could rival clopidogrel, which is set to see its patent agomelatine is the first melatonergic agent to show favorable expire in 2011. However, if the FDA requires additional results in its effect on sleep, weight, and sexual function. clinical trials to study bleeding issues that have been raised Researchers are working to develop a third generation of with these drugs, prasugrel’s approval might be delayed. antipsychotics that may provide broader efficacy, reduced side With possible approval in 2010 or 2011, effects, and improved tolerability. Several NDAs TRA-SCH-530 -348 (Schering-Plough), an oral have been submitted, eg, sertindole (Serdolect; antiplatelet drug, would be the first in a new Lundbeck), which is associated with less sedation class of thrombin-receptor antagonists. TRAwhen used to treat schizophrenia, and asenapine, POWER POINTS SCH-530348 prevents blood clots by inhibiting a new 5-HT2A/D2 receptor anatgonist for treatthrombin action. ment of schizophrenia and acute mania. More generics will enter Another new antiplatelet formulation is Two migraine treatments in the pipeline are the cardiovascular market AZD6140, the first reversible oral adenosine telcagepant (Merck), an oral calcitonin genein coming years. diphosphate (ADP) receptor antagonist. Develrelated peptide (CGRP) receptor antagonist, and oped to reduce the risk of thrombotic events in botulinum toxin A (Botox; Allergan). Migraine New agents will compete ACS patients, AZD6140 inhibits platelet aggrega- with statins in cholesterol treatment is a new indication for the latter. management. tion. Clinical benefits of reversibility are unclear; Milnacipran (Forest/Cypress), a selective however, trials now under way may shed light norepinephrine serotonin reuptake inhibitor There will be an upsurge on the issue. (NSRI), and [S,S]-reboxetine (Pfizer), a norin development of With limited clinical choices for the prevention epinephrine reuptake inhibitor, target fibroantiplatelet agents and antithrombotics. of thromboembolic disease, two anticoagulants myalgia, particularly the symptoms of fatigue could meet the need for new products in this area: and difficulty concentrating. Both drugs are in once-daily dosage of rivaroxaban, being studied phase 3 clinical trials. for prevention of venous blood clots in elective hip- or kneeThe sleep-disorder market may see the arrival of two replacement surgery, and dabigatran etexilate (Boehringer new insomnia drugs: doxepin (Silenor; Somaxon) and eplIngelheim), an oral reversible direct thrombin inhibitor. Riivanserin (Sanofi-Aventis). At press time, doxepin’s review varoxaban, a direct Xa inhibitor, is expected to enter phase 3 by FDA had been extended, with a new PDUFA (Prescriptrials for ACS in mid-2009; venous thromboembolism (VTE) tion Drug User Fee Act of 1992) date of February 29, 2009. prevention launch is estimated for later this year. Trials of dabUnlike existing sleep aids, doxepin selectively blocks the igatran for acute VTE and secondary prevention of VTE, and neurotransmitter histamine and may improve insomnia prevention of cardiovascular events in ACE, are ongoing. symptoms without serious adverse effects. Eplivanserin, Dronedarone (Multaq; Sanofi-Aventis), a multichannel a selective 5HT2A receptor antagonist, is in phase 3 trials. blocker with anti-adrenergic properties that is chemically Zolpidem extended release (Ambien CR; Sanofi-Aventis) similar to amiodarone, is being studied in patients with atrial is scheduled to go off patent in March 2009. 26 DRUG TOPICS Januar y 2009 W W W.D R U GTO P I C S .C O M GETTY IMAGES / IMAGE SOURCE http://WWW.DRUGTOPICS.COM
Table of Contents Feed for the Digital Edition of Drug Topics - January 2009 Drug Topics - January 2009 Contents Letters Up Front Up Front in Depth Community Practice Drug Pipeline: What to Watch in 2009 OTC Community-Aquired MRSA Infections New Products Viewpoint Drug Topics - January 2009 Drug Topics - January 2009 - Drug Topics - January 2009 (Page Cover1) Drug Topics - January 2009 - Drug Topics - January 2009 (Page Cover2) Drug Topics - January 2009 - Drug Topics - January 2009 (Page 1) Drug Topics - January 2009 - Drug Topics - January 2009 (Page 2) Drug Topics - January 2009 - Drug Topics - January 2009 (Page 3) Drug Topics - January 2009 - Contents (Page 4) Drug Topics - January 2009 - Contents (Page 5) Drug Topics - January 2009 - Contents (Page 6) Drug Topics - January 2009 - Contents (Page 7) Drug Topics - January 2009 - Contents (Page 8) Drug Topics - January 2009 - Contents (Page 9) Drug Topics - January 2009 - Contents (Page 10) Drug Topics - January 2009 - Contents (Page H1) Drug Topics - January 2009 - Contents (Page H2) Drug Topics - January 2009 - Contents (Page H1) Drug Topics - January 2009 - Contents (Page H2) Drug Topics - January 2009 - Contents (Page H3) Drug Topics - January 2009 - Contents (Page H4) Drug Topics - January 2009 - Contents (Page H5) Drug Topics - January 2009 - Contents (Page H6) Drug Topics - January 2009 - Contents (Page H7) Drug Topics - January 2009 - Contents (Page H8) Drug Topics - January 2009 - Contents (Page 13) Drug Topics - January 2009 - Up Front (Page 14) Drug Topics - January 2009 - Up Front (Page 15) Drug Topics - January 2009 - Up Front (Page 16) Drug Topics - January 2009 - Up Front (Page 17) Drug Topics - January 2009 - Up Front in Depth (Page 18) Drug Topics - January 2009 - Up Front in Depth (Page 19) Drug Topics - January 2009 - Community Practice (Page 20) Drug Topics - January 2009 - Community Practice (Page 20a) Drug Topics - January 2009 - Community Practice (Page 20b) Drug Topics - January 2009 - Community Practice (Page 21) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 22) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 23) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 24) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 25) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 26) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 27) Drug Topics - January 2009 - OTC (Page 28) Drug Topics - January 2009 - OTC (Page 29) Drug Topics - January 2009 - OTC (Page 30) Drug Topics - January 2009 - OTC (Page 31) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 32) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 33) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 34) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 35) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 36) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 37) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 38) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 39) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 40) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 41) Drug Topics - January 2009 - New Products (Page 42) Drug Topics - January 2009 - New Products (Page 43) Drug Topics - January 2009 - New Products (Page 44) Drug Topics - January 2009 - New Products (Page 45) Drug Topics - January 2009 - New Products (Page 46) Drug Topics - January 2009 - New Products (Page 47) Drug Topics - January 2009 - Viewpoint (Page 48) Drug Topics - January 2009 - Viewpoint (Page Cover3) Drug Topics - January 2009 - Viewpoint (Page Cover4)
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