Internal Medicine News
`
`QutineewageheseASPiesMiedintes
`
`NEWS
`NewerAtypical Antipsychotics Draw Praise
`Publish date: March 22, 2011
`By Srinse Janein
`
`EXPERT ANALYSIS FROM A PSYCHOPHARMACOLOGYCONFERENCE SPONSORED BYTHE UNIVERSITY OF ARIZONA
`
`TUCSON, ARIZ. — The most noteworthycharacteristic of lurasidone, the newest antipsychotic agent to reach the market,is its
`exceptionallyfavorable metabolic profile, according to Dr. Henry A. Nasrallah.
`
`"It has placebo-level metabolic effects,” said Dr. Nasrallah, professor of psychiatry and neuroscience at the Universityof Cincinnati.
`"The metabolic profile is better than for Geodon[ziprasidone] or Abilify [aripiprazole], which are currently accepted as the least
`metabolically adverse atypical antipsychotics."
`
`Last year saw marketing approval for asenapine (Saphris), the first sublingual antipsychotic
`
`Lurasidone (Latuda) is an oral atypical antipsychotic approved earlier this year for the
`treatmentof schizophrenia andis just now reaching pharmacyshelves. Long-term studies
`indicate that the drugis weight neutral, with no weightgain 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 of0.9 kg, while those on risperidone (Risperdal) gained an
`average of 2.6 kg. Lurasidone’s long-term impacton lipids and blood glucose has been similarly
`benign.
`
`Also,intriguingpreliminaryevidence suggests that lurasidone might have antidepressant and
`cognitive enhancementeffects, according to the psychiatrist. The dose is 40-80 mg once daily.
`
`agent. Asenapine is mucosally absorbed, so it goes directly into the bloodstream withoutfirst
`passing through the stomachandliver. That means fewer drug-druginteractions.It also makes
`asenapine a safer choicefor patients prone to overdose; mucosal absorption renders fatal overdose extremelydifficult, Dr. Nasrallah
`said at a psychopharmacologyconference sponsoredby the University ofArizona.
`
`De, Hengy 4. Nasvallah
`
`The dosing of asenapine is 5 mg b.i.d. Weight gain is relatively modest, compared with that associated with manyofthe atypical
`antipsychotics, as are adverse effects on lipids and blood glucose, he continued.
`
`lloperidone (Fanapt), approved in 2009, is an oral atypical antipsychotic dosed at 12-24 mg/dayb.i.d. The risk of hypotension makesit
`necessary to titrate to 12 mg/dayover a 4-day period.
`
`Weight gain and risk of extrapyramidal symptoms are lower than with manyofthe older atypical agents. However, prolongation ofthe
`QTinterval occurs in a small percentage ofpatients, creating what is to this pointstill merely a theoretic concern abouta possible
`increasedrisk oftorsades de pointes. Nonetheless, the QT interval prolongation findings have resulted in insertion of a warningin the
`product labeling that iloperidone should be considered a second-line agent.
`
`"To be honest,I think that the whole QT prolongation issue with our psychiatric medications has turned outto be a big exaggerated
`worry. We've seen very, very few problems with serious arrhythmias, The metabolic side effects with the atypical antipsychotic agents
`area much moreseriousissue,” Dr. Nasrallah asserted.
`
`Thelast 2 years havealso brought marketing approval of two new long-acting formulations of existing atypical antipsychotics:
`paliperidone palmitate (Invega Sustenna) and olanzapine pamoate (Zyprexa Relprevy). These long-acting products have an important
`role in patients with poor medication adherence, which Dr. Nasrallah called “a plague” in schizophrenia.
`
`1
`
`Exhibit 2073
`Slayback v. Sumitomo
`IPR2020-01053
`
`Exhibit 2073
`Slayback v. Sumitomo
`IPR2020-01053
`
`

`

`Hesaid he routinely uses a long-acting agent from the get-go in patients who've committed a violent act during their first schizophrenic
`episode, because they tend to repeat the same symptoms in subsequentepisodes.
`
`Paliperidone palmitate is given in an initial 234-mg intramuscular loading dose in the deltoid muscle followed by 156 mg after 8 days.
`Thereafter, monthly maintenance dosingis given at 39-234 mgin cither the gluteal or deltoid muscle. The drug is well tolerated overall,
`with no need for ora] supplementation.
`
`Long-acting olanzapine pamoate is a less practical drug; because ofrare side effects, its administration must be followed by direct
`observation for about 3 hours with a crash cart nearby.
`
`With the approvalof three new atypical antipsychotic medications in the past 3 years, that makes a totalof nine distinct drugs on the
`market today, some in multiple formulations. Is that redundancy? Not in Dr. Nasrallah’s view.
`
`"I'm happy that we have nine atypical antipsychotics on the market, because it turns out patients will respond to one but not another,
`and bytrial and error we find out how to use these drugs. All ofthem work in about 70% of patients, but maybe a different 70% for each.
`So me-too drugs are useful,” he said.
`
`An audience member, noting that some of the newer atypical antipsychotic drugs cost $5,000 per year, asked Dr. Nasrallah how society
`can afford them.
`
`“Don’t get me started on pharmacoeconomies,” Dr. Nazrallah said. “I am just so angry that the insurance companies somehow get away
`with discriminating against psychiatrists and psychiatric patients. When a hemophiliac needs a replacementfactor that costs $100,000
`peryear, Medicaid, Medicare, and private insurance will pay it without blinking. But schizophrenia? No, $5,000 a year is too much. And
`then there are many cancers where it costs $40,000-$60,000to prolonglife by 6 months. They pay, and they don’t makea big fuss
`about it. But they do make a big fuss about our patients and our drugs.”
`
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