Internal Medicine News.
`
`WW
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`NEWS
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`Newer Atypical Antipsychotics Draw Praise
`Publiuh date; Mach 22. 2011
`By 31569.1302211
`
`EXPFR'I' ANALYSIS FRI )M A PSYCHOPHARMAH )l.()(;\' (TIN FFRENK‘F. SPt )NSI JREI) BY'I'HR [TN IVERSI'H’ 0F ARth )NA
`
`'1'ULSUN. ARIZ. — 1119 most noteworthy charaderistie of lurasidone. the newest antipsychotie agent to reach the market, is its
`exceptionally favorable metabolic profile. according to Dr. Henry A. Nos-allnh.
`
`"It has placebo-level metabolic effects." said Dr. Rasrallah. professor of psychiatry and neuroscience at the University of Cincinnati.
`"The metabolic profile is better than for Geodon [ziprasidonel or Abilify laripiprazolel. which are currently accepted as the least
`metalmlically adverse atyqrical antipsyclmlits"
`
`l.urasidone (Latuda) isan oral atypical antipsychotic approved earlier this year for the
`treatment of schizophrenia and is just now reachingpharmaey shelves. long-term studies
`indicate that the drug is weight neutral. with no weight gain over baseline even after 6 and 12
`months of treatment. Indeed. in a 12—month head-to— head comparative study. the lurasidone-
`treated group actually lost a mean of 0.9 kg. while those on risix-ridone (Rispcrdal) gained an
`average ofzo kg. Lttrasidone‘s long-term impact on lipids and blood glucose has been similarly
`benign
`
`Also. intriguing preliminary en'dence suggests that llrrasidone might have antidepressant and
`cognitive enhancement effects. according to the psychiatrist. The dose is 40-80 mg once daily.
`
`
`
`Last year saw marketing approval for asena pine (Snphris). the first sublingual antipsyehotic
`agent. Asenapinc is mueosallyubsorbcd. so it goes directly into the bloodstream nithout first
`passing through the stomach and liner. That means fewer drug-drug interactions. It also makes
`asenirpine a safer choice for patien Ls prone to ovenlow: mucosal absorption renders fatal m‘enloseeatrenwly tliffitult. Dr. Nasrallah
`mid at a psychophannaeology «inference sponsored by the t'niversity ofArizona.
`
`~
`_
`.
`p.- 1mm 5, f.;.<:-3!L}h
`
`The dosing of asenapine is 5 mg bid. Weight gain '3 relatively modest. compared with that associated with many of the atypical
`nntipq‘ehotits. as are adverse effects on lipids and blood glucose. hemntinued.
`
`llopcridone (anpt). approved in 2009. is an oral atypical antipsychotic dosed at 12—24 mg/dnyb.i.d. The risk ofhypotension makes it
`necessary to tittate to 12 mg/day over a 4—day period.
`
`Weight gain and rislt ofextnrp)1'an1idal symptoms are lower than with many ofthe older atypical agents. However. prolongation of the
`QT inten'al occurs in a small percentage of patients. treating what is In this point still merely a theoretic concern about a [nmilrle
`increased risk oftorsades de pointes Nonetheless. the QT interval prolongation findings have resulted in insertion ofa waming in the
`product labeling that iloperidone should be considered a second-line agent.
`
`'To be honest. I think that the whole QT prolongation issue with ottr psychiatric medications has tumcd out to be u big exaggerated
`worry. We’ve seen very. very few problems with serious arrhythmias. The metabolic side effects with the atypical antipsvchotic agents
`art-a much more serious issue.” Dr. Nasrallah asserted.
`
`The last 2 years have also brought marketingappnwal oftmr new long-acting formulations of existingatypit'al anlilsyt'hotics:
`paliperidone palmitate (lnvega Srtstcnna) and olanzapine pamoale (Zypmxa Relprevv). These long-acting products have an important
`role in patients with poor medication adherence. which Dr. Namilahcalled "a plague" in schizophrenia.
`
`Exhibit 2073
`Slayback v. Sumitomo
`|PR2020—O1053
`
`Exhibit 2073
`Slayback v. Sumitomo
`IPR2020-01053
`
`

`

`Hesaid he routinely uses a long-acting agent from the get-go in patients who've mmmitted a violent act during their first schimphrenie
`episode. because they tend to repeat the lame symptoms in subsequent episodes
`
`Paliperidone palmitate is given in an initial apt-mg intramuscular loading dose in the deltoid muscle followed by 156 mgalter 8 days.
`Thereafla. monthly maintenance dosing is g'ven at ag-m mg in either the ghneal or deltoid mmcle. The drug '3 well tolerated overall.
`with no need for oral supplementation.
`
`Long-acting olamapine pamoate is a lat practical drug: became of rare side effects. its administration must be followed by direct
`observation for about 3 hours with a crash (art nearby.
`
`With the approval of three new atypical antim'chotic medications in the past 3 yearn, that makes a total of nine distinct drugs on the
`market today, some in multiple formulations. Is that redundancy? Not in Dr. Naarallah’s View.
`
`"I'm happy that we have nine atypical antipayehoties on the market, because it turm out patients will respond to one but not another,
`and by trial and error-we find out how to use these drugs.“ ofthcm work in about 70% of patients. but maybe a different 7096 for each.
`30 me-too drugs are useftd.‘ he said.
`
`An audience member. noting that some of the newer atypical antlpsyehotic drugs mat $5.000 per year. asked Dr. Nasrallah how satiety
`can afford them.
`
`"Don’t get me started on pharmacoeconomies." Dr. Nazrallah said. ”I am juatso angry that the instu'anceoompanies somehow get away
`with discriminating agaimt psychiatrists and psychiatric patients. When a hemophiliac needs a replacement factor that costs $100,000
`pcryenr. Medimid. Medicare. and private inauranocwill pay it without blinking. But schizophrenia? No. $5,000 a year is too much. And
`then there are many cancers where it costs 340300460900 to prolong life by 6 months. They pay. and they don't make a big fuss
`about it. But they domakea big fuss about our patients and out drugs.”
`
`’ Comments; ({2}
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