Extended-Release Hydrocodone Zohydro ER for Pain The FDA has approved an extended-release oral formu-lation of the opioid agonist hydrocodone Zohydro ER – Zogenix for management of pa
Trang 1The Medical Letter®
On Drugs and Therapeutics Published by The Medical Letter, Inc • 145 Huguenot Street, New Rochelle, NY 10801 • A Nonprofi t Publication
IN THIS ISSUE (starts on next page)
In Brief: A Naloxone Auto-Injector (Evzio) p 45
Extended-Release Hydrocodone (Zohydro ER) for Pain p 45
Sublingual Immunotherapy for Allergic Rhinitis p 47
In Brief: Lowering the Dose of Lunesta p 48
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On Drugs and Therapeutics Published by The Medical Letter, Inc • 145 Huguenot Street, New Rochelle, NY 10801 • A Nonprofi t Publication
ALSO IN THIS ISSUE
Sublingual Immunotherapy for Allergic
Rhinitis p 47
In Brief: Lowering the Dose of Lunesta p 48
IN BRIEF
A Naloxone Auto-Injector (Evzio)
A recent Medical Letter article reported renewed interest
in the intranasal administration (off-label) of the opioid
antagonist naloxone because of an increase in deaths
approved a more practical alternative for emergency
treatment of life-threatening opioid overdose in adults
and children: a single-dose naloxone auto-injector
(Evzio – Kaleo) for intramuscular or subcutaneous use
Evzio will be available in kits containing two prefi lled
0.4-mg auto-injectors with voice guidance and a “trainer”
device that also has voice guidance, but does not
contain medication or a needle The manufacturer has
not published a price for Evzio to date, but news reports
indicate that each kit could cost hundreds of dollars,
compared to about $20 for a standard 0.4-mg injectable
dose of naloxone, which can be given intranasally
1 Intranasal naloxone for treatment of opioid overdose Med Lett
Drugs Ther 2014; 56:21.
Extended-Release Hydrocodone
(Zohydro ER) for Pain
The FDA has approved an extended-release oral
formu-lation of the opioid agonist hydrocodone (Zohydro ER –
Zogenix) for management of pain severe enough to
require continuous, long-term therapy and for which
alternative treatment options are inadequate Zohydro ER
is the fi rst single-ingredient hydrocodone product to be
marketed in the US Hydrocodone has been available for
years in combination with acetaminophen (Vicodin, and
others) or ibuprofen (Vicoprofen, and others).1
PHARMACOLOGY — Hydrocodone is a semisynthetic
opioid It is metabolized primarily by CYP3A4-mediated
N-demethylation to norhydrocodone and to a lesser extent by CYP2D6-mediated O-demethylation to hy-dromorphone Overall hydrocodone exposure is similar
after administration of Zohydro ER or comparable daily
doses of immediate-release hydrocodone combination
products, but peak concentrations are lower with
Zo-hydro ER and it has a longer half-life Steady state is
reached after 3 days of continuous use
CLINICAL STUDY — In a clinical trial in opioid-tolerant
patients with moderate to severe chronic back pain, those who had been successfully converted from their current opioid to single-agent hydrocodone ER during
an initial open-label phase (n = 302) were randomized
to continue active treatment with fi xed stable doses of twice-daily hydrocodone ER (40-200 mg/day) or switch
to placebo in the double-blind phase After 12 weeks, the average daily pain intensity score increased signifi cantly more with placebo than with hydrocodone ER.2
ADVERSE EFFECTS — The most common adverse
effects of hydrocodone ER during the clinical trial were constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting, and pruritus Use of hydrocodone, particularly at high doses, has rarely been associated with sensorineural hearing loss.3 Overdosage with any opioid can result in respiratory depression and death Crushing, chewing, snorting, or injecting
the contents of Zohydro ER capsules could result in
uncontrolled delivery of hydrocodone, possibly leading to overdose and death
Hydrocodone ER is classifi ed as category C (teratogenic effects in animals; no adequate human studies) for use during pregnancy Infants born to mothers who received opioid therapy while pregnant may need treatment for neonatal opioid withdrawal syndrome
POTENTIAL FOR ABUSE — Hydrocodone is a
schedule II controlled substance Combination pain medications containing hydrocodone are currently classifi ed as schedule III, but the DEA, following an FDA recommendation, has proposed reclassifi cation
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Trang 346 The Medical Letter • Volume 56 • Issue 1444 • June 9, 2014
of these products to schedule II The new single-entity,
extended-release capsule formulation is not
tamper-resistant and is expected to be associated with higher
As part of a Risk Evaluation and Mitigation Strategy
(REMS) program, the FDA has required that healthcare
providers receive training in use of extended-release
or long-acting opioids such as hydrocodone ER before
prescribing them
DRUG INTERACTIONS — Taking hydrocodone ER
with a CYP3A4 inhibitor such as clarithromycin (Biaxin,
and generics) could result in increased plasma
concen-trations of the opioid.6Mixed agonist/antagonist opioid
analgesics such as pentazocine (Talwin) or
butorpha-nol (Stadol, and generics) could decrease the
analge-sic effect of hydrocodone ER and result in withdrawal
symptoms Urinary retention and severe constipation,
possibly leading to paralytic ileus, could occur with
concurrent use of hydrocodone ER and an
anticholin-ergic drug Use of hydrocodone ER within 14 days of a
monoamine oxidase inhibitor is not recommended
Coadministration of 40% alcohol resulted in a 2.4-fold
increase in peak concentrations of hydrocodone ER
Taking hydrocodone ER with CNS depressants such
as alcohol, sedatives, or other opioids can increase
the risk of profound sedation, respiratory depression,
coma, and death
DOSAGE AND ADMINISTRATION —Opioids have no
ceiling on their analgesic effect, except that imposed
by adverse effects The recommended starting dosage
of Zohydro ER in opioid-naive or opioid non-tolerant
patients is 10 mg twice daily The dosage can be in-creased by 10 mg twice daily as needed every 3-7 days
to achieve adequate pain relief For patients switching from another opioid, the dosage depends on the previ-ous drug and its dose; conversion ratios for different
opioids are listed in the prescribing information
Zo-hydro ER capsules should be swallowed whole and
should not be broken, crushed, dissolved, or chewed
To prevent withdrawal symptoms when discontinuing therapy, the dose should be tapered gradually
CONCLUSION — The new extended-release formulation
of hydrocodone (Zohydro ER) is the fi rst
single-entity form of the drug; it permits higher dosing than immediate-release hydrocodone, which is only available
in combination with ibuprofen or acetaminophen Like
other extended-release opioids, Zohydro ER is likely to
be abused, and the FDA has required special training for prescribers □
1 Drugs for pain Treat Guidel Med Lett 2013; 11:31.
2 RL Rauck et al Single-entity hydrocodone extended-release cap-sules in opioid-tolerant subjects with moderate-to-severe chronic low back pain: a randomized double-blind, placebo-controlled study Pain Med 2014; Feb 12 (epub).
3 D Krashin et al Extended-release hydrocodone – gift or curse? J Pain Res 2013; 6:53.
4 FDA Background Material – NDA 202880 Zohydro ER (hydro-codone) for the management of moderate to severe chronic pain Meeting of the AADPAC, December 7, 2012 Available at www.fda gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ ucm330683.pdf Accessed May 29, 2014
5 Y Olsen and JM Sharfstein Chronic pain, addiction, and Zohydro New Engl J Med 2014; 370:2061
6 Inhibitors and inducers of CYP enzymes and P-glycoprotein Med Lett Drugs Ther 2013; 55:e44.
Table 1 Some Extended-Release Oral Opioids
Hydrocodone
Zohydro ER (Zogenix) 10, 15, 20, 30, 40, 50 mg ER caps 10 mg q12h 12 hrs $351.00 Hydromorphone
Exalgo (Mallinckrodt) 8, 12, 16, 32 mg ER tabs Footnote 3 24 hrs 380.10 4
Morphine
Avinza (Pfi zer) 30, 45, 60, 75, 90, 120 mg ER caps 30 mg q24h 24 hrs 159.00
Kadian (Actavis) 10, 20, 30, 40, 50, 60, 70, 80, 30 mg q24h 12-24 hrs 210.60
100, 130, 150, 200 mg ER caps
MS Contin (Purdue) 15, 30, 60, 100, 200 mg ER tabs 15 mg q12h 8-12 hrs 133.80
Oxycodone
OxyContin (Purdue) 10, 15, 20, 30, 40, 60, 80 mg ER tabs 10 mg q12h 12 hrs 136.20 Oxymorphone
Opana ER (Endo) 5, 7.5, 10, 15, 20, 30, 40 mg ER tabs 5 mg q12h 12 hrs 112.80
1 For patients who are not opioid tolerant For patients switching from another opioid, starting dosage is based on previous opioid dosage Long-acting formulations are generally not recommended for opioid-naive patients.
2 Approximate wholesale acquisition cost (WAC) for 30 days’ treatment at the starting dosage Source: Analy$ource® Monthly (Selected from FDB MedKnowledge™) May 5,
2014 Reprinted with permission by FDB, Inc All rights reserved ©2014 www.fdbhealth.com/policies/drug-pricing-policy Actual retail prices may be higher.
3 Only recommended for patients who are opioid tolerant Starting dosage determined by previous opioid dosage
4 Cost for 30 8-mg ER tablets.
Trang 4Sublingual Immunotherapy for Allergic
Rhinitis
The FDA has approved 3 allergen extracts for sublingual
administration as immunotherapy for allergic rhinitis
confi rmed by a positive skin test or in vitro testing for
pollen-specifi c IgE antibodies: Oralair (Stallergenes
S.A./Greer) and Grastek (Merck) for grass
pollen-induced allergic rhinitis and Ragwitek (Merck) for short
ragweed pollen-induced allergic rhinitis
ALLERGIC RHINITIS — Orally administered
second-generation H1-antihistamines are the preferred fi rst-line
therapy for relief of itching, sneezing, and rhinorrhea
as-sociated with mild to moderate allergic rhinitis Intranasal
corticosteroids are the most effective drugs available for
prevention and relief of allergic rhinitis symptoms,
includ-ing itchinclud-ing, sneezinclud-ing, discharge, and congestion, and are
the drugs of choice for moderate to severe disease.1
allergic rhinitis has required subcutaneous injection
of gradually increasing doses of the relevant inducing
allergen such as tree, grass, or weed pollen It can alter
the natural history of the disorder, and the benefi ts may
last for years after injections are discontinued, but its
use has been limited by the need for continued (usually
monthly) maintenance injections and concerns about
local or systemic adverse effects, including, rarely,
anaphylaxis Sublingual allergen immunotherapy for
treatment of allergic rhinitis and allergic conjunctivitis
induced by airborne allergens has been used for years
in Europe.2
CLINICAL STUDIES — Randomized, double-blind,
placebo-controlled trials with Oralair and Grastek in both
adults and children and with Ragwitek in adults have
shown that all of these agents, started 3-4 months
be-fore and taken daily throughout the pollen season, can
reduce symptom scores and use of other medications by
20-40%.3-6 One 5-year study in adults found that taking
Grastek for 3 consecutive years reduced symptom scores
for 3 years; the effect was sustained during the allergy
season in the fi rst year after stopping Grastek, but not in
the second year.7
ADVERSE EFFECTS — Local adverse effects are
com-mon after the fi rst few doses (and sometimes after sub-sequent doses) with all 3 allergen extracts These include itching of the mouth, ear, and tongue, throat irritation, and oropharyngeal edema Anaphylaxis has occurred rarely; auto- injectable epinephrine should be available These extracts should not be used in patients with unstable or severe asthma or in those with active infl ammatory oral lesions or open areas after tooth loss or extraction
Oralair and Grastek are classifi ed as category B (no
evidence of risk in animals; no human studies) and
Ragwitek as category C (risk cannot be ruled out) for
use during pregnancy Immunotherapy should not be started during pregnancy
DRUG INTERACTIONS — All 3 allergen-extract
sublingual tablets should be used with caution in patients also taking a beta-adrenergic blocker, an alpha-adrenergic blocker, an ergot alkaloid, a tricyclic antidepressant, a monoamine oxidase inhibitor, or le-vothyroxine because these drugs can either potentiate
or inhibit the effect of epinephrine if it is needed to treat
an allergic reaction
DOSAGE AND ADMINISTRATION — Sublingual
immunotherapy should begin at least 12 weeks (16
weeks for Oralair) before the start of the allergy
season and continue daily for the duration of the season The tablet should be placed under the tongue for at least 1 minute Patients should not eat or drink while taking the tablet and for 5 minutes afterwards Because of the potential for anaphylaxis and laryngopharyngeal edema, the fi rst dose should be administered in a healthcare setting and patients should
be observed for at least 30 minutes after the fi rst dose; subsequent doses can be taken at home, but patients should have auto-injectable epinephrine available and
be trained in its use The optimal duration of treatment remains to be established
Table 1 Sublingual Allergen Immunotherapy Extracts for Allergic Rhinitis
Oralair (Stallergenes Sweet vernal, orchard 100 IR (~3000 BAUs) 10-17 years: 100 IR SL $10.00
Grastek (Merck) Timothy grass 2800 BAUs sublingual tabs 5-65 years: 1 tab SL 8.30
once/day
Ragwitek (Merck) Short ragweed 12 Amb a 1-unit 18-65 years: 1 tab SL 8.30
IR = index of reactivity; BAUs = bioequivalent allergy units; SL = sublingually
1 Approximate wholesale acquisition cost (WAC) of one tablet Source: Analy$ource® Monthly (Selected from FDB MedKnowledge™) May 5, 2014 Reprinted with permission by FDB, Inc All rights reserved ©2014 www.fdbhealth.com/policies/drug-pricing-policy Actual retail prices may be higher.
Trang 548 The Medical Letter • Volume 56 • Issue 1444 • June 9, 2014
On Drugs and Therapeutics
EDITOR IN CHIEF: Mark Abramowicz, M.D
EXECUTIVE EDITOR: Gianna Zuccotti, M.D., M.P.H., F.A.C.P., Harvard Medical School EDITOR: Jean-Marie Pfl omm, Pharm.D
ASSISTANT EDITORS, DRUG INFORMATION: Susan M Daron, Pharm.D.,
Corinne Z Morrison, Pharm.D., Michael P Viscusi, Pharm.D.
CONSULTING EDITORS: Brinda M Shah, Pharm.D., F Peter Swanson, M.D CONTRIBUTING EDITORS:
Carl W Bazil, M.D., Ph.D., Columbia University College of Physicians and Surgeons Vanessa K Dalton, M.D., M.P.H., University of Michigan Medical School Eric J Epstein, M.D., Albert Einstein College of Medicine
Jane P Gagliardi, M.D., M.H.S., F.A.C.P Duke University School of Medicine Jules Hirsch, M.D., Rockefeller University
David N Juurlink, BPhm, M.D., Ph.D., Sunnybrook Health Sciences Centre Richard B Kim, M.D., University of Western Ontario
Hans Meinertz, M.D., University Hospital, Copenhagen Sandip K Mukherjee, M.D., F.A.C.C., Yale School of Medicine Dan M Roden, M.D., Vanderbilt University School of Medicine Esperance A.K Schaefer, M.D., M.P.H., Harvard Medical School
F Estelle R Simons, M.D., University of Manitoba Neal H Steigbigel, M.D., New York University School of Medicine Arthur M F Yee, M.D., Ph.D., F.A.C.R., Weill Medical College of Cornell University SENIOR ASSOCIATE EDITOR: Amy Faucard
MANAGING EDITOR: Susie Wong ASSISTANT MANAGING EDITOR: Liz Donohue PRODUCTION COORDINATOR: Cheryl Brown EXECUTIVE DIRECTOR OF SALES: Gene Carbona FULFILLMENT & SYSTEMS MANAGER: Cristine Romatowski DIRECTOR OF MARKETING COMMUNICATIONS: Joanne F Valentino VICE PRESIDENT AND PUBLISHER: Yosef Wissner-Levy
Founded in 1959 by Arthur Kallet and Harold Aaron, M.D.
Copyright and Disclaimer: The Medical Letter is an independent nonprofi t organization that provides health care professionals with unbiased drug prescribing recommendations The edi-torial process used for its publications relies on a review of published and unpublished litera-ture, with an emphasis on controlled clinical trials, and on the opinions of its consultants The Medical Letter is supported solely by subscription fees and accepts no advertising, grants, or donations No part of the material may be reproduced or transmitted by any process in whole
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Copyright 2014 ISSN 1523-2859
Coming Soon in The Medical Letter:
Tobramycin Inhalation Solution (Bethkis) for Cystic Fibrosis
A Transcutaneous Electrical Nerve Stimulation Device (Cefaly)
for Migraine
Luliconazole (Luzu) for Tinea Infections
Treatment of Atrial Fibrillation
CONCLUSION — Sublingual immunotherapy with
Oralair and Grastek for treatment of grass
pollen-induced allergic rhinitis and with Ragwitek for short
ragweed pollen-induced allergic rhinitis can reduce
the symptoms of allergic rhinitis How sublingual
immunotherapy with pollens compares to subcutaneous
immunotherapy in effi cacy and safety remains to be
established Both are expensive; second-generation
H1-antihistamines and intranasal corticosteroids, both
available over the counter, are relatively inexpensive
options for symptom control □
1 Drugs for allergic disorders Treat Guidel Med Lett 2013; 11:43.
2 SY Lin et al Sublingual immunotherapy for the treatment of allergic
rhinoconjunctivitis and asthma: a systematic review JAMA 2013;
309:1278.
3 LS Cox et al Clinical effi cacy of 300IR 5-grass pollen sublingual
tablet in a US study: the importance of allergen-specifi c serum IgE
J Allergy Clin Immunol 2012; 130:1327.
4 A Didier et al Sustained 3-year effi cacy of pre- and coseasonal
5-grass-pollen sublingual immunotherapy tablets in patients with
grass pollen-induced rhinoconjunctivitis J Allergy Clin Immunol
2011; 128:559.
5 J Maloney et al Effi cacy and safety of grass sublingual
immuno-therapy tablet, MK-7243: a large randomized controlled trial Ann
Allergy Asthma Immunol 2014; 112:146
6 PS Creticos et al Randomized controlled trial of a ragweed allergy
immunotherapy tablet in North American and European adults J
Allergy Clin Immunol 2013; 131:1342.
7 SR Durham et al SQ-standardized sublingual grass
immuno-therapy: confi rmation of disease modifi cation 2 years after 3 years
of treatment in a randomized trial J Allergy Clin Immunol 2012;
129:717.
IN BRIEF
Lowering the Dose of Lunesta
The FDA has required the manufacturer of eszopiclone
(Lunesta – Sunovion), a benzodiazepine receptor
agonist approved for the treatment of insomnia, to
lower the current recommended starting dose to 1 mg
for both men and women because a new study found
that an evening dose of 3 mg can impair driving skills,
memory, and coordination for more than 11 hours.1
Eszopiclone’s half-life is longer than that of any other
drug in its class, which includes zolpidem (Ambien,
and generics) and zaleplon (Sonata, and generics)
All benzodiazepine receptor agonists may impair
performance the next morning, including driving.2
Anterograde amnesia and complex sleep-related
behaviors without conscious awareness may also
occur Hallucinations have been reported Like the
benzodiazepines, benzodiazepine receptor agonists
are schedule IV controlled substances; withdrawal,
dependence, and abuse can occur
1 FDA Drug Safety Communication FDA warns of next-day
impairment with sleep aid Lunesta (eszopiclone) and lowers
recommended dose Available at www.fda.gov/Drugs/DrugSafety/
ucm397260.htm Accessed May 29, 2014.
2 Drugs for insomnia Treat Guidel Med Lett 2012; 10:57.
Trang 6The Medical Letter®
Online Continuing Medical Education
To take CME exams and earn credit, go to:
medicalletter.org/CMEstatus Issue 1444 Questions
(Correspond to questions #67-72 in Comprehensive Exam #70, available July 2014)
Extended-Release Hydrocodone (Zohydro ER) for Pain
1 Compared to similar doses of immediate-release hydrocodone, Zohydro ER :
a is more effective
b causes fewer adverse effects
c has a longer duration of action
d none of the above
2 A 55-year-old man with chronic back pain tells you that he has seen ads on
TV for Zohydro ER and asks if he could try it He currently takes Vicodin as
needed for back pain but says that he usually only needs one or two tablets
a day to control his pain He also takes the anticholinergic drug oxybutynin for urinary incontinence You could tell him that:
a you would recommend a starting dose of 50 mg q12h
b you have no concerns about Zohydro ER interacting with any of
his current medications
c he could crush the Zohydro ER capsules if they are too large to
swallow
d none of the above
3 Zohydro ER :
a is not affected by concurrent use of alcohol
b is tamper-resistant
c is more effective than other long-acting opioids for chronic pain
d none of the above
Sublingual Immunotherapy for Allergic Rhinitis
4 A mother asks you about the new products that she has heard about for grass pollen allergy and wants to know if they would help her 9-year-old daughter’s allergy symptoms You could tell her that:
a they need to be taken daily starting at least 12 weeks before
allergy season
b after taking them for 1 year, they will prevent symptoms of grass
pollen allergy for life
c unlike traditional allergen-specifi c immunotherapy that requires
subcutaneous injection, the new sublingual therapies do not pose a risk for anaphylaxis
d all of the above
5 Adverse effects of the 3 new allergen extracts for sublingual administration
as immunotherapy for allergic rhinitis include:
a itching of the mouth, ear, and tongue
b throat irritation
c oropharyngeal edema
d all of the above
In Brief: Lowering the Dose of Lunesta
6 The recommended starting dose of Lunesta is now:
a 0.5 mg
d 3 mg
Trang 7Earn Up to 26 Category 1 AMA PRA credits
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