New Drug Update 2019

45th Annual Oklahoma Academy of Physician Assistants CME Conference

September 20, 2019

Katherine S. O’Neal, Pharm.D., MBA, BCACP, CDE, BC-ADM, AE-C, CLS, FAADE
Associate Professor: University of Oklahoma College of Pharmacy
Adjunct Associate Professor: University of Oklahoma Department of Medicine
Katherine-oneal@ouhsc.edu
 Objectives

• Describe new medications, formulations, and indications

by therapeutic class

• Summarize key adverse effects and monitoring

parameters for the new therapeutic agents

• Compare and contrast new medications with existing

medication options
2
Sharma K. FDA CDER New Drugs Program: 2018 Update, Dec. 2018 3
Sharma K. FDA CDER New Drugs Program: 2018 Update, Dec. 2018
Sharma K. FDA CDER New Drugs Program: 2018 Update, Dec. 2018 5
 Therapeutic Categories
• Dermatology
• Psychiatry
• Neurology
• Endocrinology
• Respiratory
• Ophthalmology
• Pain
• Infectious Disease
• Rheumatology
• Vaccines
http://www.centerwatch.com; Lexi-Comp 6
DERMATOLOGY
 Glabellar Lines
Drug(s) • Jeuveau (prabotulinumtoxinA-xvfs)

Class • Acetylcholine inhibitor and neuromuscular

blocker
Indication • Temporary improvement in the appearance of
moderate to severe glabellar lines
Dosing • 0.1 mL (4 units) injected intramuscularly into
each of the five sites (2 injections in each
corrugator muscle and 1 in mid-line of procerus
muscle) for a total dose of
20 units; Do not
administer more frequently
than every 3 months
8
• Blocks neuromuscular transmission by binding to acceptor sites on
motor nerve terminals, entering the nerve terminals and inhibiting the
release of acetylcholine. This occurs while the neurotoxin cleaves
SNAP-25, integral to releasing acetylcholine. Produces partial
denervation of the muscle
9
 PrabotulinumtoxinA-xvfs
Considerations
Adverse • Headache, eyelid ptosis, upper respiratory tract
Effects infection, leukocytosis
Monitor • Difficulty swallowing, muscle weakness,
ophthalmic effects
Caution • BBW* affects may spread from the area of
injection to produce symptoms consistent with
botulinum toxin effects; symptoms can appear
hours to weeks after injection
Price • No pricing information available

BBW: Black box warning 10

 PrabotulinumtoxinA-xvfs
Bottom Line
Evidence 2 Phase III randomized, multicenter, double-blind,
for placebo-controlled trials enrolling 654 patients aged
Approval 18-81 randomized 3 to 1 to treatment or placebo

Outcomes Participants had moderate to severe glabellar lines.

Demonstrated efficacy compared to placebo in the
reduction of severity of glabellar lines at day 30; 67.5%
of patients in study 1 and 70.4% of patients in study 2
achieved primary outcomes; Efficacy identified by ≥2
grade improvement from baseline assessed by
investigator and patient using Glabellar Line Scales
Place in Patients who have built a tolerance to traditional Botox
Therapy therapy

Jeuveau (PrabotulinumtoxinA-xvfs) FDA package insert; 7/2019 11

 Plaque Psoriasis
Drug(s) • Skyrizi (risankizumab-rzaa)
Class • Antipsoriatic, Interleukin-23 inhibitor,
monoclonal antibody
Indication • Moderate to severe plaque psoriasis

Dosing • Two consecutive subcutaneous injections at

different locations (75mg each) for a total of
150mg at weeks 0, 4, and then 12 and then
every 12 weeks thereafter

12
• Selectively binds to the p19 subunit of IL-23
inhibiting the release of proinflammatory cytokines
and chemokines 13
 Risankizumab Considerations
Adverse • Antibody development, upper respiratory tract
Effects infection, headache
Monitor • Tuberculosis screening prior to initiating and
periodically through therapy, signs and
symptoms of infection
Caution • Immunizations should be up to date prior to
starting therapy
Price • $17,700 per injection
• www.skyrizi.com has $5 copay
discount program for eligible
patients

14
 Risankizumab Bottom Line
Evidence 4 randomized, placebo and/or active-controlled studies:
for ultIMMA-1, ultIMMA-2, IMMhance, and IMMvent. Primary
Approval endpoints were Psoriasis Area and Severity Index (PASI 90)
and statis Physician Global Assessment (sPGA) score of
clear or almost clear at 16 weeks

Outcomes 997 participants in ultIMMA-1 and 2, PASI 90 was achieved

in 75% (p<0.001). PASI 100 was achieved in 36% and 51%
(p<0.001). Patients maintained PASI 90 or 100 at one year,
88% and 80% (p<0.001). IMMhance enrolled 507 patients
and 84% achieved sPGA of 0 or 1 and 73% PASI 90.
IMMvent demonstrated superiority over adalimumab, 72%
vs. 47% achieving PASI 90 (p<0.001)
Place in Dosing frequency is less than Siliq (every 2 weeks), no
Therapy BBW, one dosing regimen for all patients compared to
weight based dosing for ustekinumab; very similar to Ilumya
and Tremfya (with higher PASI scores)

Reich K. Risankizumab compared with adalimumab. Lancet; 2019;394. Gordon KB. ultIMMA-1 and 2. Lancet. 2018;392. 15
Psoriasis Dosage Forms

16
PSYCHIATRY
 Postpartum Depression
Drug(s) • Zulresso (brexanolone)
Class • Gamma-aminobutyric acid A receptor positive
modulator
Indication • Postpartum depression

Dosing • Continuous IV infusion over 2.5 days

0-4 hours: 30 mcg/kg/hour
4-24 hours: increase to 60 mcg/kg/hour
24-42 hours: increase to 90 mcg/kg/hour
52-56 hours: decrease dose to 60 mcg/kg/hour
56-60 hours: decrease to 30 mcg/kg/hour

18
• Allosteric modulator of both synaptic and
extrasynaptic GABAA receptors resulting in varying
degrees of desired activity
19
 Brexanolone Considerations
Adverse • Sedation, dry mouth, presyncope, vertigo,
Effects flushing, tachycardia, drowsiness
Monitor • Continuous pulse oximetry, sedation every 2
hours, suicidal ideation

Caution • Black box warning for excessive sedation or

sudden loss of consciousness

Price • $447/mL

20
 Brexanolone Bottom Line
Evidence Two multicenter, randomized, double-blind, placebo-
for controlled studies with women age 18-45 with
Approval postpartum depression

Outcomes Study 1 participants had Hamilton Depression Rating

Scale (HAM-D) ≥26 and Study 2 included patients with
HAM-D between 20-25. Primary endpoint was mean
change from baseline. Both studies found
improvement in symptoms with a mean reduction of
19.5 points (p=0.0013) in Study 1 and 14.6 points in
Study 2 (p=0.0160)
Place in First drug specifically indicated for postpartum
Therapy depression; Only available through restricted program
Zulresso REMS

Kanes S. Brexanolone. Lancet. 2017;390. Meltzer-Brody S. Brexanolone Phase 3. Lancet. 2018;392

21
 Depression
Drug(s) • Spravato (esketamine)
Class • N-Methyl-D-Aspartate (NMDA) Receptor
Antagonist
Indication • Treatment resistant depression in adults in
conjunction with oral antidepressant
Dosing • Intranasal
• Induction: 56 mg twice weekly, may increase
up to 84 mg twice weekly
• Maintenance: Beginning Week 5, decrease
frequency to once weekly, at week 9 adjust
frequency to least frequent interval, once
weekly or every 2 weeks

22
• S-enantiomer of racemic ketamine 23
 Esketamine Considerations
Adverse • Hypertension, depersonalization, dissociative
Effects reaction, sedation, vertigo, drowsiness,
headache, derealization
Monitor • Monitor for 2 hours after dose administration,
blood pressure (prior to dose, 40 min post dose,
2 hours post dose), worsening depression
Caution • BBW: abuse potential, sedation, dissociation,
suicidal ideation

Price • $354/device
• Janssen Care Path Care Coordinator
to help with affordability

BBW: Black box warning 24

 Esketamine Bottom Line
Evidence 3 4-week trials and one longer-term trial phase 3 multi
for center, double-blind randomized trial in, which 705
Approval patients were enrolled and at week 16 those that
achieved stable remission or stable response entered
withdrawal phase and randomized to continue
receiving treatment or discontinue treatment
Outcomes Primary endpoint was change from baseline in the
Montgomery-Asberg Depression Rating Scale. One of
the three short term trials demonstrated improvement
in severity within 2 days (p=.001). In the longer trial,
176 patients (n=297) achieved stable remission
(NNT=6, P=0.003) and 24 relapsed. Trial
demonstrated 51% relapse risk reduction
Place in Spravato REMS program, truly treatment resistant
Therapy
Jaskaran B. IV Esketamine in Adult-Treatment Resistant Depression. Biological Psychiatry. 2016;424. Fedgchin M. Efficacy and Safety of
Fixed-Dose Esketamine. Int J Neuropsychopharmacol. 2019. 25
 (Jornay PM) Methylphenidate
– New Formulation
Indication • Attention deficit/hyperactivity disorder, age 6
and older
Dose • Initial 20 mg once daily in the evening between
6:30PM and 9:30PM; may increase dose in
increments of 20mg/day at weekly intervals,
maximum daily dose 100 mg/day
• Comes in 20, 40, 60, 80, and 100 mg capsules
Price • $14.80/capsule
• www.jornaypm.com/savings/ if eligible $30
copay program
Product

26
NEUROLOGY
 Daytime Sleepiness
Drug(s) • Sunosi (Solriamfetol)
Class • Dopamine and norepinephrine reuptake
inhibitor
Indication • To improve wakefulness in adult patients with
excessive daytime sleepiness due to narcolepsy
or obstructive sleep apnea
Dosing • Narcolepsy: 75 mg once daily in the morning,
may increase at at an interval of 3 days to
maximum dose of 150 mg
• Obstructive Sleep Apnea: 37.5 mg once daily
in the morning, may increase at an interval of 3
days to max dose of 150 mg

28
 Solriamfetol Considerations
Mechanism • Dopamine and norepinephrine reuptake
of Action inhibitor, exact mechanism unknown
Adverse • Headache, decreased appetite, anxiety,
Effects nausea
Monitor • Blood pressure and heart rate

Caution • Cardiovascular and psychiatric effects, abuse

potential

Price • $26.40/tablet

29
 Solriamfetol Bottom Line
Evidence OSA: 12-week multi-center, randomized, placebo-
for controlled study with 476 patients, randomized to 37.5,
Approval 75, 150 and 300mg
Narcolepsy: 12-week multi-center, randomized,
double-blind, placebo-controlled, parallel-group with
239 patients randomized to 75, 150, and 300mg
Outcomes OSA: Significant improvements seen in Maintenance
of Wakefulness Test (MWT) and Epworth Sleepiness
Scale (p<0.05) (ESS). All doses except 37.5mg had
higher percentages of patients reporting improvement
on Patient Global Impression of Change (p<0.05)
Narcolepsy: 150mg showed statistically significant
results on MWT and ESS (p<0.0001)
Place in First dual acting dopamine and norepinephrine
Therapy reuptake inhibitor approved for this; provides another
option for wakefulness than CNS stimulants
Schweitzer PK. Solriamfetol OSA. Am J Respir Crit Care Med. 2019;199(11). Thorpy MJ. Narcolepsy. Ann Neurol. 2019;85(3):359 30
 Multiple Sclerosis
Drug(s) • Mayzent (Siponimod)
Class • Sphingosine 1-Phosphate (S1P) Receptor
Modulator
Indication • Treatment of relapsing forms of multiple
sclerosis (MS), including clinically isolated
syndrome, relapsing-remitting disease, and
active secondary progressive disease
Dosing • Dose based off CYP2C9 genotype
• Genotype *1/*1, *1/*2, *2/*2
0.25mg Day 1 and 2, 0.5mg Day 3, 0.75mg
Day, 1.25mg Day 5 then 2mg once daily
• Genotype *1/*3, *2/*3
0.25mg Day 1 and 2, 0.5mg Day 3, 0.75mg
Day, then 1mg once daily 31
• Siponimod binds with high affinity to S1P
receptors blocking lymphocytes, reducing the
number of lymphocytes in the peripheral
blood
32
 Siponimod Considerations
Adverse • Hypertension, Headache, peripheral edema,
Effects bradycardia, increased serum bilirubin,
increased serum transaminases
Monitor • CBC, hepatic monitoring, ECG, ophthalmic
evaluation
Caution • Rebound syndrome, test for antibodies to
varicella zoster prior to initiation if history of
chickenpox or VZV vaccination status is
unknown, patients may require overnight
monitoring during initiation if prolonged QTc
interval
Price • $72.74-290.96 per tablet
• Mayzent.com $0 co-pay if eligible
33
 Siponimod Bottom Line
Evidence Phase III, randomized, double-blind, placebo-
for controlled study-EXPAND trial; enrolled 1651 patients
Approval with secondary progressive MS and expanded
disability status scale (EDSS) of 3-6.5
Outcomes 2mg dose significantly reduced the risk of 3-month
confirmed disability progression (21% risk reduction,
p=0.013) and in patients with relapse activity in the 2
years prior to screening 33% risk reduction, p=0.01)
and annual relapse rate reduction of 55%
Place in Provides another less expensive alternative; Only
Therapy other S1P receptor modulator is Fingolimod (Gilenya)
~$328.43/tablet

Kappos L. EXPAND trial. Lancet. 2018;391:1263 34

 Migraine
Drug(s) • Emgality (galcanezumab-gnlm)
• Ajovy (fremanezumab-vfrm)
Class • Calcitonin gene-related peptide antagonist
(CGRP)
Indication • Emgality: Preventive treatment for cluster
headache during cluster episodes or preventive
treatment for migraine
• Ajovy: Preventive for migraine
Dosing • Emgality: 120mg injected subcutaneously once
monthly (Loading dose of two 120mg injections)
• Ajovy: 225mg injected subcutaneously once
monthly of 675mg every 3 months

35
 CGRP Considerations
Adverse • Antibody development, injection site reaction
Effects

Monitor • Migraine frequency

Caution • Immunogenicity, CVD

Price • Emgality: $575-690/dose; Lily’s Patient Support

Program, 12 months free if commercially
insured, emgality.com
• Ajovy: $460/dose, ajovyhcp.com discount pgm

37
 CGRP Bottom Line
Evidence for Emgality: EVOLVE1 and 2 (episodic migraines, 4-14/month, 1,773
Approval patients) and REGAIN (chronic migraine, >15/month, 1,113 patients).
Cluster trial enrolled 106 patients
Ajovy: FOCUS trial (episodic migraine 838 patients and chronic migraines
509 patients). Study 1 enrolled 875 patients with episodic migraines. Study
2 enrolled 1,130 patients with chronic migraines.

Outcomes Emgality: Significant change in headache days: EVOLVE1 -4.7 days

(p<0.001); EVOLVE2 -4.3 days (p<0.001); REGAIN -4.8 days (p<0.001);
cluster headached 71.4% of patients had weekly cluster headaches cut in
half or more (p=0.046). ~28-62% patients achieved >50% reduction
Ajovy: FOCUS for chronic migraine -4.1 days (p<0.0001) and quarterly -3.7
days (p<0.0001); Study 1 -4.9 days monthly dosing and -3.9 days quarterly
dosing (p<0.001). Study 2 -4.6 days monthly dosing and -4.3 days quarterly
dosing (p<0.001). ~39-46% patients achieved >50% reduction
Place in Another option to Aimovig (erenumab) ($345-690/dose) but now with
Therapy quarterly dosing option with Ajovy (fremanezumab); Erenumab studies
demonstrated up to -6.6 days with monthly dosing. Ajovy and Emgality do
not contain Latex derivatives

Silberstein SD. EVOVLE1 and 2. J Headache Pain. 2019;20(1):75. Detke HC. REGAIN. Neurology. 91;e2211. Ferrari MD. FOCUS. Lancet.
2019;19(3):31946. Dodick DW. Fremanezumab. JAMA. 2018;15:319(19); Silberstein SD. Fremanezumab. N Engl J Med. 2017;377:2113 38
(Tosymra) Sumatriptan – New
Formulation
Indication • Acute treatment of migraine with or without
aura
Dose • 10mg (1 spray) in one nostril. Max dose is
30mg over 24 hours with doses separated by
1 hour
Price • None available

Product

39
 (Inbrija) Levodopa – New
Formulation
Indication • Intermittent treatment of OFF episodes in
patients with Parkinson Disease treated with
carbidopa/levodopa
Dose • One inhalation (84mg) up to 5 times daily (max
420mg/day)
Price • $19/dose

Product

40
ENDOCRINOLOGY
 Osteoporosis
Drug(s) • Evenity (Romosozumab)
Class • Sclerostin inhibitor
Indication • Treatment of osteoporosis in postmenopausal
women at high risk for fracture, defined as
history of osteoporotic fracture, or multiple risk
factors for fracture, or patients who have failed
other therapy
Dosing • Two 105 mg subcutaneous injections (total dose
210 mg) once monthly for 12 months

42
 Romosozumab
Considerations
Adverse • Arthralgias, cardiac disorder, headache,
Effects insomnia, muscle spasm
Monitor • Signs/symptoms of adverse cardiovascular
events, serum calcium
Caution • Black box warning for increase risk of MI,
stroke, CV death

Price • $935.90/dose
• www.evenityhcp.com Medicare Part B

44
 Romosozumab Bottom Line
Evidence 2 phase III RCT (FRAME and ARCH). FRAME has 7,180
for patients (also had a 12 month extension of denosumab) and
Approval ARCH had 4,093 patients (also had 12 month extension of
alendronate)
Outcomes FRAME trial, compared romosozumab vs. placebo in
women with T-score -2.5 to -3.5, patients had 73% lower risk
of new vertebral fractures, increased BMD at spine, hip and
femoral neck by 13.3%, 6.9%, and 5.9%
ARCH trial, romosozumab vs. alendronate in women with
osteoporosis and history of fragility fracture, 48% lower risk
of new vertebral factures, 19% lower risk of nonvertebral
factures, and 38% lower risk of hip fractures. Both follow-up
trials showed significantly reduced the incidence of new
vertebral factures.
Place in High risk patients and only for 12 months of therapy
Therapy

Lexi-Comp; Tu K. Osteoporosis: A Review of Treatment Options. P&T. 2018;43(2):92-104; Saag KG. Romosozumab or Alendronate for
fracture prevention in women with osteoporosis. NE JM 2017; 377(15):1417. 45
 Bijuva (estradiol and
progesterone) – New
Formulation
Indication • First bioidentical oral hormone combination of
estradiol and progesterone indicated for the
treatment of moderate to severe hot flashes due
to menopause
Dose • One tablet (estradiol 1mg/progesterone 100mg)
each evening with food
Price • $8.58/tablet

Product

46
 Birth Control
Drug(s) • Annovera (Segesterone acetate and Ethinyl
estradiol)
Class • Oral contraceptive
Indication • To prevent pregnancy

Dosing • Segesterone acetate 0.15mg/ethinyl estradiol

0.013mg. Insert 1 ring vaginally. Keep in place
for 21 days then remove for 7 days (1 cycle).
Continue this pattern for 13 cycles (1 year)

47
 Segesterone Considerations
MOA • Suppresses ovulation

Adverse • Headache, migraine, nausea, abdominal pain,

Effects vulvovaginal candidiasis, vaginal discharge, CV
Monitor • Blood pressure, weight, pregnancy status
Caution • Contraindicated in females at high risk of
arterial or venous thromboembolism

Price • $2400/ring

48
 Segesterone Bottom Line
Evidence 2 1-year multicenter trials enrolling 2,265 patients aged
for 18-40 who were healthy and sexually active
Approval
Outcomes Pooled pregnancy rate was 2.98 per 100 woman years
of annovera use (95% CI 2.13-4.06). Return to fertility
was achieved in all women who desired it within 6-
months
Place in First vaginal ring to provide 1 year of birth control;
Therapy provides another option

Archer Df. Sestesterone. Lancet Glob Health. 2019;7(8):e1054. 49

 Qternmet – New Combo
Combination • Dapagliflozin (SGLT2), saxagliptin (DPP4)
and metformin (Biguanide)
Indication • Type 2 diabetes
Dose • One tablet daily
• Fixed Doses (dapa/saxa/metformin)
5 /5 /1000 mg
10 /5 /2000 mg
Price • None available

Product • Qtern already available as a combination of

dapagliflozin and saxagliptin

50
 (Baqsimi) Glucagon – New
Formulation
Indication • Treatment of severe hypoglycemia in pediatric
patients ≥4 years of age and adults
Dose • One actuation (3mg) into single nostril; if no
response may repeat in 15 minutes using a new
intranasal device
Price • $336/device

Product

51
RESPIRATORY
 COPD
Drug(s) • Yupelri (Revefenacin)
Class • Long acting anticholinergic
Indication • Maintenance treatment of COPD

Dosing • One unit dose vial via nebulization daily (175

mcg)
Mechanism • Long-acting muscarinic antagonist that
of Action competitively and reversibly inhibits
acetylcholine at the M3 receptor causing
bronchodilation

53
 Revefenacin Considerations
Adverse • Headache, hypertension, nasopharyngitis,
Effects upper respiratory track infection
Monitor • FEV1, peak flow, LFT
Caution • Not for acute treatment
Price • $13.73/mL
• https://www.activatethecard.com/yupelri/#
Savings card for $0 copay

54
 Revefenacin Bottom Line
Evidence 2 RCT enrolling over 1,250 patients 40 years of age
for and older with moderate to severe COPD. 88mcg dose
Approval compared to 175mcg compared to placebo.

Outcomes Primary endpoint was 24-hour trough FEV1 on day 85.

Improvements in FEV1 (118mL for 88mcg dose and
145mL for 175mcg, p<0.0001). Overall treatment effect
on trough FEV1 and peak FEV1 was significantly
improved (115mL and 142mL, p<0.001)

Place in Adds to options for long acting anticholinergic (LAMA)

Therapy and only 2nd LAMA available via nebulization but this
one is administered once daily

Ferguson GT. Chronic Obstr Pulm Dis. 2019; 6(2): 154

55
 Duaklir Pressair (aclidinium
bromide and formoterol
fumerate) – New Formulation
Indication • Maintenance treatment of COPD
Dose • 1 inhalation twice daily (aclidinium
400mcg/formoterol 12 mcg/inhalation)
Price • None available

Product

56
 Advair – New Generic
Name • Wixela Inhub (fluticasone and salmeterol)
Dose • One inhalation twice daily in patients 4 years
of age and older (100/50mcg, 250/50 mcg,
500/50mcg)
Price • $6-9.84/dose (www.wixela.com $10 copay
program) compared to $13-21/dose
Product

57
 ProAir Digihaler (Albuterol) –
New Formulation
Indication • Treatment of prevention of bronchospasm in
reversible obstructive airway disease and
prevention of exercise induced bronchospasm
Dose • 1-2 inhalations every 4-6 hours
Price • None available, launch 2020

Product • Built-in sensors detect and measure

inspiratory flow, 200 inhalations, breath
activated

58
OPHTHALMOLOGY
 (Rocklatan) Latanoprost and
Netarsudil) – New Combo
Indication • Reduction of elevated intraocular pressure in
patients with open-angle glaucoma or ocular
hypertension
Dose • Rocklatan (netarsudil 0.02% (Rho Kinase
inhibitor) and latanoprost 0.005%
(Prostaglandin analog)) One drop in affected
eye once daily in the evening
Price • $125.57/mL

Product

60
 (Xelpros) Latanoprost – New
Formulation
Indication • Reduction of elevated intraocular pressure in
patients with open-angle glaucoma and ocular
hypertension
Dose • One drop in the affected eye once daily in the
evening
Price • $26.40/dose

Product • First and only form of latanoprost that is not

formulated with benzalkonium chloride
(preservative)

61
PAIN
 Naloxone – New Generic
Indication • Complete or partial reversal of opioid
depression induced by natural and synthetic
opioids
Dose • 4mg (1 nasal spray) as a single dose in one
nostril; may repeat every 2-3 minutes in
alternating nostrils until medical assistance
becomes available
Price • None available

Product • First generic nasal spray

63
INFECTIOUS DISEASES
 Influenza

Drug(s) • Xofluza (Baloxavir)

Class • Endonuclease inhibitor
Indication • Influenza

Dosing • 40-79kg: 40mg as a single dose within 48

hours onset of symptoms
• 80kg or more: 80mg as a single dose within
48 hours onset of symptoms

65
• Oral prodrug that inhibits endonuclease
activity polymerase acidic protein, which is
required for viral transcription, inhibiting virus
replication
66
 Baloxavir Considerations
Adverse • Diarrhea, nasopharyngitis
Effects
Monitor • Potential secondary bacterial infections
Caution • Not for use in illnesses caused by other
pathogens
Price • $90/dose

67
 Baloxavir Bottom Line
Evidence 2 RCT enrolling 1,832 patients randomized to xofluza,
for placebo, or oseltamivir
Approval
Outcomes Compared to placebo, significantly shorter time to
alleviation of symptoms (50 hrs vs 78 hrs; 54 hrs vs 80
hrs). No difference compared to oseltamivir (both 54
hours)

Place in Provides another option; not approved for patients <12

Therapy whereas oseltamivir is indicated in patients 2 weeks
and older; no dosage adjustments needed (oseltamivir
has renal dosing); single dose vs 5 day treatment

Hayden FG. Baloxavir. N Engl J Med. 2018;379(10):913

68
 Traveler’s Diarrhea

Drug(s) • Aemcolo (Rifamycin)

Class • Antibacterial
Indication • Treatment of traveler’s diarrhea caused by
noninvasive strains of Escherichia coli in adults
Dosing • 388mg twice daily for 3 days

Mechanism • Inhibits bacterial synthesis by inhibiting the

of Action beta-subunit of the bacterial DNA-dependent
RNA polymerase

69
 Rifamycin Considerations
Adverse • Headache, constipation, dyspepsia
Effects
Monitor • Bloody stools, frequency of diarrhea

Caution • Prolonged use

Price • $14.40/tablet

70
 Rifamycin Bottom Line
Evidence 2 RCT: Study 1 performed in Guatemala and Mexico
for (264 patients) randomized rifamycin to placebo and
Approval Study 2 was conducted in India, Guatemala, and
Ecuador (835 patients) randomized rifamyin to
ciprofloxacin
Outcomes Outcome was the length of time between
administration of the first dose and passage of the
unformed stool. Aemcolo was dosed 388mg twice daily
for 3 days and demonstrated superiority to placebo (46
hrs vs 68 hrs, p=0.008) and noninferiority to
ciprofloxacin (42.8 vs 36.8 hrs, p=0.0035)
Place in Provides another option to Xifaxan ($24.85-
Therapy 47.37/tablet) or flouroquinolones

Dupont HL. Rifamycin. J Travel Med. 2014;21(6):369l Steffen R. Rifamycin and Cipro. J Travel Med. 2018;25(1)
71
Community Acquired Pneumonia

Drug(s) • Nuzyra (omadacycline)

Class • Tetracycline derivative
Indication• Community acquired pneumonia (CAP) and
acute bacterial skin and structure infections
(ABSSSI)
Dosing • CAP: 300mg once daily for 7-14 days
• ABSSSI: 450mg once daily for 2 days then
300mg once daily for 5-12
• Comes in IV formulation as well
Mechanism • Inhibits protein synthesis by binding with the
of Action 30S ribosomal subunit of susceptible bacteria
72
 Omadacycline Considerations
Adverse • Nausea, vomiting, hypertension
Effects
Monitor • Renal and hepatic function
Caution • Antianabolic effects, pancreatitis,
photosensitivity
Price • $237/tablet
• www.nuzyra.com/hcp/nuzyra-central patient
support information

73
 Omadacycline Bottom Line
Evidence 2 RCT, CAP: 774 patients randomized to omadacycline
for vs. moxifloxacin for 7-14 days; ABSSSI: 1390 patients
Approval randomized to omadacycline vs. linezolid for 7-14 days
who had cellulitis, major abscess, or wound infection
Outcomes CAP: Demonstrated noninferiority: Compared 100mg
IV omadacycline vs 400mg IV moxifloxacin with option
to transition to oral after 3 days (300mg and 400mg)
(clinical response 81.1% vs 82.7%, 95% CI -7.1 to 3.8)
ABSSSI: Demonstrated noninferiority: Compared
100mg IV omadacycline vs 600mg IV linezolid with
option to transition to oral after 3 days (300mg and
600mg) (clinical response 84.8% vs 85.5%, 95% CI -
6.3 to 4.9)
Place in Provides another option. Mortality rate was higher with
Therapy omadacycline group vs. moxifloxacin; significant drug
interactions
Stets R. Omadacycline. N Engl J Med. 2019;380(6):517. O’Riordan W. Omadacycline ABSSSI. N Engl J Med. 2019;380(6):528 74
 Acne
Drug(s) • Seysara (Sarecycline)
Class • Tetracycline derivative
Indication• Inflammatory lesions of non-nodular moderate
to severe acne in patients 9 years of age and
older
Dosing • 33-54kg: 60 mg once daily
• 55-84kg: 100 mg once daily
• 85-136kg: 150 mg once daily
• If no improvement after 12 weeks reassess
Mechanism • Inhibits protein synthesis by binding with the
of Action 30S and possibly 50S ribosomal subunit of
susceptible bacteria

75
 Sarecycline Considerations
Adverse • Nausea
Effects
Monitor • Ophthalmic evaluation of visual disturbances
Caution • CNS effects, tissue hyperpigmentation, tooth
enamel hypoplasia and permanent tooth
discoloration in pediatric patients
Price • $34.40/tablet

76
 Sarecycline Bottom Line
Evidence Two identically designed trials enrolling a total of 2,002
for patients aged 9-45 with Investigator’s Global
Approval Assessment Score (IGA) ≥3, 20-50 inflammatory and ≤
100 noninflammatory lesions randomized to 1.5
mg/kg/day or placebo for 12 weeks
Outcomes Assessing improvement in acne severity by IGA score
improvement of 2 or more grades
Study 1: IGA 21.9% vs 10.5% (p<0.0001), reduction in
inflammatory lesions 51.8% vs. 35.1% (p<0.0001)
Study 2: IGA 22.6% vs 15.3% (p=0.0038), reduction in
inflammatory lesions 49.9% vs. 35.4% (p<0.0001)
Place in Provides another option, efficacy seen as early as 3
Therapy weeks

Moore A. Sarecycline. J Drugs Dermatol. 2018;17(9):987

77
RHEUMATOLOGY
 Gloperba (Colchicine) – New
Formulation
Indication • Gloperba (colchicine)
Dose • 0.6mg/5mL oral solution, 5mL once or twice
daily (maximum dose 1.2mg/day)
Price • None available

Gloperba (colchicine) FDA Package Insert, 1/2019

79
VACCINES
 Combo Vaccine
Drug(s) • Vaxelis (Diphtheria and Tetanus Toxoids,
Acellular Pertussis, Hepatitis B (recombinant),
Poliovirus (inactivated), and Haemophilus
influenzae B conjugate (adsorbed)
Indication • Primary immunization infants and children 6
weeks to 2 years of age and booster
immunization (12-23 months)
Dose • Primary: IM 0.5mL for 3 doses with at least 1
month in between (may do 2 doses or 3 doses
if full term)
• Booster: IM 0.5mL at 12 to 23 months at least
6 months after last priming dose
Price • None available, commercially available in 2020

81
Gardasil 9 – Expanded Indication

Indication • Women and men aged 27-45 (from age 9-26)

for the prevention of certain cancers and
diseases caused by the 9 HPV types
Dose • 3-dose series 0.5mL at 0, 2 and 6 months
Price • None available

Product • Study found that Gardasil 9 was 88% effective

in providing coverage for men and women
aged 27-45

82
 Adacel – Expanded Indication

Drug(s) • Adacel (Diphtheria and Tetanus Toxoids and

Acellular Pertussis)
Indication • Repeat vaccination 8 years or more after first
vaccination in people aged 10-64
Dose • 0.5mL

Price • $54.15/dose
Product • Only Tdap vaccine available in a syringe made
without natural rubber latex

83
 Review Question 1
Which of the following drug:indication pairings
is correct?

A. Fremanezumab: Migraine
B. Sarecycline: Community Acquired
Pneumonia
C. Revefenacin: Traveler’s Diarrhea
D. Romosozumab: Type 2 Diabetes

84
Review Question 2
Which drug provides a new oral formulation
dosage form to its product line of tablets?

A. Jeaveau
B. Zulresso
C. Spravato
D. Gloperba

85
Review Question 3
Which drug contains three separate
ingredients for the treatment of type 2
diabetes?

A. Sunosi
B. Qternmet
C. Mayzent
D. Evenity

86
MEDICATION & FORMULARY
RESOURCES AND OTHER
HELPFUL
RESOURCES/INFORMATION
 Community & Other
Medication Resources
• Reasor’s Free Antibiotic Program for Children (10-day
supply)
• WalMart $4 ($9) List (updated 11/2018)
• Genscripts (cash only, bulk quantities, will mail)
• Tulsa County Pharmacy
• Oklahoma County Pharmacy
• http://freeclinicdirectory.org/oklahoma_care/oklahoma_o
k_county.html
• Tulsa Bedlam Charitable Pharmacy
• OKC Good Shepard Clinic
• RX4 OKLA https://okcommerce.gov/assistance/rx/
• Prescription Assistance www.needymeds.org
88
 Insurance 101
• Private Commerical insurances
– Formularies updated annually
– Tier system
1 $
2 $$
3 $$$

• Formulary Comparison
https://lookup.decisionresourcesgroup.com/
• State Medicaid/Soonercare
– Step system
– Documented reason to move to next level
– www.okhca.org (Oklahoma Healthcare Authority) 89
OHCA – Diabetes Example

90
91
 New Drug Update 2019
45th Annual Oklahoma Academy of Physician Assistants CME Conference
September 20, 2019

Katherine S. O’Neal, Pharm.D., MBA, BCACP, CDE, BC-ADM, AE-C, CLS, FAADE
Associate Professor: University of Oklahoma College of Pharmacy
Adjunct Associate Professor: University of Oklahoma Department of Medicine
Katherine-oneal@ouhsc.edu