New Drug Update 2009-2010 - LAFP

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The FDA’s Reproductive Health Advisory Committee is scheduled to meet on June 18, 2010 to review the request from Boehringer Ingelheim to approve flibanserin for the treatment of Female Hypoactive Sexula Desire Disorder or HSDD. Flibanserin (BIMT -17) was originally studied in Europe for the treatment of depression as it as effects on several of the endogenous neurotransmitters including reducing serotonin levels while increasing levels of norepinephrine and dopamine. While the trials in patients with major depressive disorder were not beneficial it did suggest that many women experienced an unexpected side effect of boosting libido which prompted the company to study this agent for HSDD. The trials to date have included more than 5,000 premenopausal women ages 18-50 in the US, Canada and Europe with a diagnosis of HSDD. The 100 mg daily dose increased the number of satisfying sexual experiences that these women reported from the previous month (a key benchmark that the FDA has set for approval of agents in this area) from an average of 2.7 up to 4.5, compared to 3.7 among those taking placebo. The primary adverse effects seen to date have been nausea, dizziness and drowsiness and no serious complications have been reported to date Recent findings presented at the 58th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco, include data from a pre-specified pooled analysis of two pivotal North American trials (DAISY® and VIOLET®) assessing flibanserin 100mg in pre-menopausal women suffering from HSDD. The pooled analysis included 1,378 pre-menopausal women with HSDD treated with either flibanserin 100mg or placebo for 24 weeks. The women evaluated their overall improvement in "bothersome decreased sexual desire" using the Patient's Global Impression of Improvement (PGI-I), which is a 7-point scale from 1 (very much improved) through 4 (no change) to 7 (very much worse). By 24 weeks, 48.3 percent of women receiving flibanserin and 30.3 percent of women receiving placebo reported feeling very much improved, much improved or minimally improved (p
June 13, 2010 Modest lung-cancer signal with angiotensin-receptor blockers a significant excess of fatal cancers was observed in the CHARM study with the ARB candesartan (Atacand, AstraZeneca), published in 2003, but that the investigators concluded this finding was likely due to chance. In the past few years there have been several other multicenter trials with ARBs, so he and his colleagues decided to perform a meta-analysis of all the available literature and all of the data publicly available on the FDA website. New cancer data were available for 61 950 patients from five trials, including only three of the seven FDAapproved ARBs; most patients in this meta-analysis (85.7%) received telmisartan (Micardis, Boehringer Ingelheim) as the study drug; the other patients received losartan or candesartan. The five trials with new cancer data were ONTARGET, PROFESS, LIFE, TRANSCEND, and CHARM-Overall. In addition, data were available for cancer deaths in LIFE, TRANSCEND, VALIANT, and Val-HeFT. In the meta-analysis, patients randomly assigned to receive ARBs had a significantly increased risk of new cancer occurrence, compared with those in the control groups (7.2% vs 6.0%; risk ratio [RR] 1.08; p=0.016). When analysis was limited to trials where cancer was a prespecified end point, the RR was 1.11 (p=0.001). Dr Sipahi said the number needed to treat to cause one excess cancer was calculated to be 105 patients for four years, meaning the risk for the individual patient is not huge, "given the millions of patients on these drugs, this is an important number, because it gives us an idea of potentially how many excess cancers could be caused by these medications. On a population level, I think these are very concerning signals." Among the malignancies examined—lung, breast, and prostate—only new lung-cancer occurrence was significantly higher in those randomly assigned to ARBs than in control subjects (0.9% vs 0.7%; RR 1.25; p=0.01). There was also a "weak trend" for an increased risk of prostate cancer with ARB use, Sipahi said. In summary this meta-analysis may be viewed as "inconclusive or hypothesis-generating," and the authorf admits the data "could be viewed as preliminary, so we need more studies in this area." First, this should involve "the US FDA looking at the individual patient-level data, which they have and we don't have, to clarify this cancer risk with ARBs. Until this is done wwe should probably use ACE inhibitors first and consider ARBs when patients do not tolerate an ACE inhibitor. Lancet Oncol 2010; DOI:10.1016/S1470- 2045(10)70106-6. Available at http://www.thelancet.com. June 14, 2010 The FDA is conducting a safety review of the angiotensin receptor blocker (ARB) olmesartan (Benicar, Daiichi Sankyo) after determining that diabetic patients taking the drug in two completed phase 3 trials may have had an excess risk of cardiovascular death. The safety announcement says that the FDA's review is "ongoing, and the agency has not concluded that Benicar increases the risk of death. FDA currently believes that the benefits of Benicar in patients with high blood pressure continue to outweigh its potential risks." The agency also notes that "other controlled clinical trials evaluating Benicar and other ARBs have not suggested an increased risk of cardiovascular-related death." In the Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) study, conducted in Europe, 4447 patients with diabetes and at least one additional cardiovascular risk factor, but no evidence of renal dysfunction, were randomized to receive either olmesartan at 40 mg/day (n=2232) or placebo (n=2215). The trial, sponsored by Sankyo Pharma, ended in July 2009. There were 15 cardiovascular deaths—including seven cases of sudden death, five fatal MIs, two fatal strokes, and one death related to coronary revascularization—in the olmesartan group compared with a total of three CV deaths—one sudden death and two fatal strokes—in the control group. In the Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial (ORIENT), conduced in Japan and Hong Kong, 566 patients with diabetes and renal dysfunction were randomized to receive olmesartan at 10 mg/day to 40 mg/day (n=282) or placebo (n=284). Of the 10 cardiovascular deaths in the olmesartan group, five were sudden death, one was a fatal MI, three were fatal strokes, and one was of unknown CV cause. Three patients in the control group died, two from sudden death and one from MI. ORIENT, sponsored by Daiichi Sankyo, was completed in February 2009. "In considering the results of these trials, it is important to remember that numerous clinical trials with olmesartan as well as trials with other ARBs have not suggested an increased risk of cardiovascularrelated death," the FDA announcement notes. Still, the "FDA plans to review the primary data from the two trials and the total clinical-trial data on olmesartan. 17
Page 1 and 2: New Drug Update 2009-2010 C. Wayne
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Page 15: about PCV2, a contaminant in RotaTe
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Page 45 and 46: than a month after drug infusion. A
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Palpitations 2% 8% 7% 7% Upper resp
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Agent Table 10. Dosage Forms for th
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Percentage rating study drug “goo
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Acute intoxication Warnings and Pre
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DOSING: Tapentadol may be taken ora
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In elderly patients with psychosis
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Investigations Weight increased
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3 mg tablets of repspiridone are $2
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Table 2. Pharmacokinetics of the Be
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haloperidol (P = 0.006). No differe
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Priapism X X X X Cognitive and moto
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Flatulence 1.9% 1.3% 1.6% 5.1% 2.3%
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adjustment in hepatic impairment re
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dosing, inhibition of platelet aggr
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thrombocytopenic purpura has been r
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“Despite the thumbs-up, the panel
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dronedarone and its N-debutyl metab
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ANDROMEDA Study (Increased Mortalit
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In clinical trials, patients treate
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Dronedarone was developed to lack a
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BENZYL ALCOHOL 5% LOTION - Ulesfia
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Table 2. Contraindications, Warning
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pediculocides, to improve outcomes.
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adolescents (ages 13-17), respectiv
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with TS+ADHD, aged 8 to 16 years. T
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HOW SUPPLIED/COST/STORAGE AND HANDL
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Pitavastatin - Livalo by Kowa and L
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Sipuleucel - T - Provenge by Dendre
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Women who are not pregnant and use
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Ketorolac tromethamine Nasal Spray-
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DENOSUMAB - Prolia by Amgen INDICAT
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71% for the pooled denosumab groups
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The most frequently observed advers
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New Drug Update 2009-2010 - LAFP

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