Michael Palladini RPh MBA CAC infodrugsofabusenet BUNAVAIL is the first and only FDAapproved buccal film formulation of buprenorphine and naloxone and will compete in the 17 billion and growing US opioid dependence market ID: 649627
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Medication Assisted TreatmentMichael Palladini, RPh MBA CACinfo@drugsofabuse.netSlide2
“BUNAVAIL is the first and only FDA-approved buccal film formulation of buprenorphine
and naloxone and will compete in the $1.7 billion and growing U.S. opioid dependence market
.”
-NASDAQ, 9/3/14Slide3
Objectives List the medications by generic and brand name, as well as appropriate starting and maintenance dosages for each, utilized for medication assisted treatment.Identify the pharmacological properties of the medications used for opioid dependence treatment, how these properties benefit patients, and the proper use in a clinical setting.
Describe the withdrawal symptoms of opioid dependence and the significance of these symptoms in initiating and maintaining treatment with specific medications.Slide4Slide5Slide6
Vermont Governor Shumlin's 2014 State of the State AddressSlide7
Opiates/OpioidsMorphineCodeineHeroinOxycodone
Hydrocodone
Oxymorphone
HydromorphoneFentanylBuprenorphineMethadone“Traditional Pain Relievers”Slide8
OpioidsTherapeutic Effects
Analgesia
Sedation/Relaxation
EuphoriaCough SuppressionSide Effects
Nausea/Vomiting
Dizziness
Headache
Constipation
Sweating
Pruritus
Dry mouth
Miosis
Respiratory DepressionSlide9
Tolerance
1. Pharmacokinetic
2. Pharmacodynamic
3. LearnedSlide10
Early Withdrawal Fully Developed WithdrawalMuscle achesrestlessness
anxiety
lacrimation
(eyes tearing up) runny nose excessive sweating inability to sleep yawning very oftendiarrhea
abdominal cramping
goose bumps on the skin
nausea and vomiting
dilated pupils and possibly blurry vision
rapid heartbeat
high blood pressureSlide11
Current Medications:Slide12
History of MAT
Late 19
th
Early 20th CenturyPublic perceptions/useAddiction ≠
Disease
Increased use in 1950’s and 1960’s
Addiction
=
Disease
Methadone useSlide13
MethadoneSynthetic opioid“Full agonist action”Use in opioid dependence circa 1965Narcotic Addict Treatment Act of 1974Considerable federal and state regulationsSlide14
BuprenorphineDATA 2000Semi synthetic opioid“Partial agonist action”The “DEA physician waiver” Slide15
NaltrexoneSynthetic molecule“Antagonist action”FDA original approval for opioid dependence 1984FDA approved for alcohol dependence 1994Vivitrol® FDA approved in 2006 (alcohol),
2010 (opioid)Slide16Slide17
Opiate ReceptorsReceptor
Location
Function
Mu1Brain, Spinal Cord, Intestinal TractAnalgesia,
Physical Dependence
Mu
2
Brain, Spinal Cord, Intestinal Tract
Respiratory Depression, Euphoria,
Miosis
, GI Motility, Physical Dependence
Delta
Brain, Peripheral
Sensory Neurons
Analgesia, Physical Dependence, Antidepressant Effects
Kappa
Brain,
Spinal Cord, Peripheral Sensory Neurons
Dissociative,
Dysphoria
,
Miosis
, SedationSlide18
Mu ReceptorSlide19Slide20
TreatmentMethadone (Highly Regulated)Buprenorphine (Moderately Regulated)Naltrexone (Slightly Regulated)Slide21
MethadoneDEA Schedule 2Clinic Setting Only28 PA. CODE CH 715 -Clinic policy/procedures -Physician/Staffing criteriaSlide22
MethadoneGeneric drug (Roxane, Mallinckrodt Pharma)Available in 5mg, 10mg Tablets“
Methadose
” 40mg wafer
10mg/ml liquid syrupOral dosage formulationsSlide23
MethadoneStarting Dose = 30mgInstitute upward titrationMaintenance Dosage ranges from: 1 or 2 mg to >200mg/dailyOnce daily dosing
“Privilege” dosing schedules
Step 0 through Step 6Slide24
MethadoneInactive metabolitesHalf-life avg. of 30hrs; range of 4 to 91 hrs2 to 4 hrs peakMetabolized extensively by CYP450 systemCost = $100/weekSlide25
Methadone IssuesAbuse/Diversion/Overdose Use of other drugs -Opiates/Cocaine/BenzodiazepinesDrug Interactions
-Significant
Dosing Issues
-Complex/Extensive Metabolism -Prolonged WithdrawalSlide26
BuprenorphineDEA Schedule 3Only FDA approved medication for OP (Physician-Office Based) treatment of opiate dependenceDATA 2000Sublingual FormulationSlide27
BuprenorphineSuboxone® (Reckitt-Benckiser)Buprenorphine (Formerly Subutex®, Generic)Zubsolv® (
Orexo
Pharma)Bunavail® (BioDelivery Sciences)Slide28
SuboxoneSlide29
ZubsolvSlide30
BunavailSlide31
Administration of Buprenorphine
Sublingual
BuccalSlide32
BuprenorphineStarting dose = 16mg bid or 32mg tidVariable maintenance dosing -2mg to 24mg daily -single or divided dosingSlide33
Buprenorphine1 to 4 hours peakHalf life of 20 to 73 hours8 -12 hrs duration (<4mg)24 -72 hrs duration (>16mg)Partial mu agonist/Kappa antagonist
Active metabolites
Cost = Office visit ($100 to $400/month)
Cost = Medication ( $5 to $8/dose)Slide34
Buprenorphine IssuesAbuse/Diversion/OverdoseTreatment/Counseling issues -DATA 2000 requirements -Payer requirements
Drug Interactions
Slide35
NaltrexoneNon-scheduled medicationVivitrol® (Alkermes)380mg IM q28 days
7-10 days opiate free period
Cost= $800+ per monthly injectionSlide36
NaltrexoneSlide37
Naltrexone
Initial peak at 2 hours
Second peak at 2-3 days
Plasma concentrations begin to decline at 14 days Half life 5-10 daysSlide38
Naltrexone IssuesVulnerability to opioid overdosePrecipitation of opioid withdrawalSwitching from agonist therapyCostSlide39
“You can check out any time you like, but you can never leave”Slide40
MAT Issues/Questions/ConcernsHarm Reduction vs. Drug Free ModelsDiversionTapering/DetoxProfit Motives
Long Term Effects
Lack of Data