sinol pharmacy education webinar 6-2-09.pdf

8/14/2019 Sinol Pharmacy Education Webinar 6-2-09.pdf

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Complementary & Alternate Medicines forAllergies & Sinus Congestion:

Making sense of the data for you and your customers


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Introduction

Allergic rhinitis and

sinus congestion are

commonly encountered

complaints and result insignificant morbidity

Number of persons in the US with:

Allergic rhinitis - 40 million1

Chronic sinusitis - 35 million2

Another 58 million have non-allergic

rhinitis which can complicate the above

conditions

1. National Institute of Allergy and Infectious Diseases.20032. National Institute of Allergy and Infectious Diseases.2007


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2ndleading cause of chronic disease in US

50% of those affected have suffered > 10 years

Prevalence is increasing

Allergic Rhinitis

Marple BF, Fornadley JA, Patel AA, et al. OtolaryngolHNS. 2007;136:S107-24.


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Allergic Rhinitis

20% of patients believe their health care provider doesnot take their symptoms seriously enough

37 % of patients are not satisfied with their current

allergy treatment

Patients may take up to 2 to 4 medications at a time forrelief of allergy symptoms

42 % of patients are confused by choices of medication

59 % wished they knew more about the drugs they take

http://www.medicalnewstoday.com/articles/56516.php


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Burden of Allergic Rhinitis

Annoying / embarrassing nasal, ocular symptoms

QoL impact

Sleep, psychomotor functioning, decision-making, well-being

Burden to the healthcare system

Significant healthcare costs (~$6 billion direct & indirect)

Burden to employers

Decreased work productivity, absences, presenteeism

3.5 million lost work days, 2 million missed school days


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Therapeutic Options


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ConventionalTreatment Options

oral and intranasal antihistamines

oral and intranasal corticosteroids

oral and intranasal decongestants

leukotriene modifiers

immunotherapy

Compliance with treatment may be limited due to: side-effects such astaste, sedation, rebound, costs (direct and indirect), ease of use


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Relative Effectiveness of Medicationsused to treat allergic rhinitis

Wallace et al. J Allergy Asthma Clin Immunol 2008; 122: S1-84.

Bousquet et al.Allergy2008; 63: S8-S160.

Medication

Class

Sneezing Itching Congestion Rhinorrhea Eyes Inflammation

Oralantihistamines

++ ++ +/- ++ + +

Intranasalantihistamines

++ ++ ++ ++ +/- +

Intranasalcorticosteroids

++ ++ ++ ++ + ++

Leukotrienemodifiers

+/- +/- - +/- +/- +

Cromolyn sodium + + - + + +

Decongestants - - ++ - - -

++ substantial benefit+ modest benefit+/- little or no benefit- no benefit


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Complementary & AlternateMedicine use (US)

Barnes PM, Bloom B, Nahin R. CDC National Health Statistics Report # 12. Dec 2008

People are increasingly usingcomplementary and alternatemedicine (CAM).

CAM use among adults isgreatest among women and thosewith higher levels of educationand income.


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Complementary & Alternate(CAM) Options

1. Colloidal silver

2. Oral homeopathic substancesi.e.

i. Arsenicum album

ii. Kali bichromicum

iii. Pulsatilla

iv. Luffa Operculata

v. Echinacea and Turmeric

3. Saline (drops/spray/wash)

4. Intranasal antifungal agents

5. Capsaicin nasal spray

6. Nutritionals

i. Bromelain

ii. Quercetin

iii. Vitamin C

iv. Garlic

Limited clinical evidence for most CAMs.


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Colloidal Silver

Over-the-counter colloidal silver products are not considered by the U.S.Food and Drug Administration (FDA) to be generally recognized as safe andeffective for diseases and conditions

The FDA has taken action against a number of colloidal silver companies

for making drug-like claims about their products

Colloidal silver can cause serious side effects including argyria, a bluish-gray discoloration of the body. Argyria is not treatable or reversible.

No clinical studies to support the use of colloidal silver in allergicrhinitis or sinusitis


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Luffa Operculata (Zicam)

Placebo-controlled,double-blindstudy of 32 pts with seasonalallergic rhinitis. Patients receivedZicam or placebo 4xday / nostrilfor 14 days

1endpoint was the change frombaseline in the overallRhinoconjunctivitis Quality of

Life Questionnaire (RQLQ)

4 x daily Zicam improved patientrelated QoL and reducedimpairment in day to dayactivities

Nobel S, The Internet Journal of Family Practice. ISSN: 1528-8358

RQLQ Scores% decrease from baseline


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Nasal Saline (Drops/Spray/Wash)

Sinusitis: studies have reported improved QoL on disease-specific questionnaires

Allergic rhinitis: positive effects have been noted in studies inchildren and in adults when nasal saline is used in conjunctionwith medication and when used as a placebo treatment

Nasal saline is generally accepted as aneffective adjunctive therapy for allergic rhinitis,

non-allergic rhinitis, and rhinosinusitis.

Harvey R et al. Cochrane Database Syst Rev. 2007:3Rabago D et al. Ann Fam Med. 2006;4:295-301.Garavello W et al. Pediatr Allergy Immunol. 2003;14:140-143
http://images.google.com/imgres?imgurl=http://www.nyee.edu/images/ent_rss_mts_005.jpg&imgrefurl=http://www.nyee.edu/ent_rss_mts.html&h=320&w=290&sz=22&hl=en&start=15&um=1&usg=__4chJVK7rSHBfrh27Ofp7D2FpiRY=&tbnid=PJL2EL0kDbZ7EM:&tbnh=118&tbnw=107&prev=/images?q=saline+nasal+wash&um=1&hl=en&rlz=1T4GZAY_enUS247US248&sa=Nhttp://images.google.com/imgres?imgurl=http://healthinmotion.files.wordpress.com/2008/02/15.jpg&imgrefurl=http://healthinmotion.wordpress.com/2008/02/&h=500&w=392&sz=28&hl=en&start=4&um=1&usg=__KAdHeTW_QPkSJj-EXa1GS4MIttk=&tbnid=or5dv44r5bWVnM:&tbnh=130&tbnw=102&prev=/images?q=saline+nasal+wash&um=1&hl=en&rlz=1T4GZAY_enUS247US248&sa=Nhttp://images.google.com/imgres?imgurl=http://farm1.static.flickr.com/44/135121043_9b64a51ac8.jpg?v=0&imgrefurl=http://flickr.com/photos/35468137479@N01/135121043&h=333&w=500&sz=67&hl=en&start=10&um=1&usg=__CfummsHYo9DQL7Iz6rZW1N4OVLY=&tbnid=CRydvkx1qd1wGM:&tbnh=87&tbnw=130&prev=/images?q=saline+nasal+wash&um=1&hl=en&rlz=1T4GZAY_enUS247US248&sa=N


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Antifungal Therapy

6 controlled trials of anti-fungal therapy in chronicrhinosinusitis

2 demonstrated benefit but have significant flaws1,2

- short length of treatment- lack of descriptive methods to evaluate compliance to therapy

- inadequate power to detect a difference between groups

- fungi not eradicated in the treatment group

4 showed no benefit3-6

1. Shin SH et al.J Allergy Clin Immunol 2004; 114:1369-1375.2. Liang KL et al.Am J Rhinol 2008; 22:52-58.3. Ebbens FA et al.J Allergy Clin Immunol 2006; 118:1149-1156.4. Ponikau JU et al J Allergy Clin Immunol 2005; 15:125-131.

5. Kennedy DW,et al.Laryngoscope 2005; 115:1793-1799.6. Weschta M et al.J Allergy Clin Immunol 2004; 113:1122-1128.


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Capsaicin

1. Lacroix JS et alClin Exp Allergy 1991;21:595-600

2. Kitajari M, et al Acta Otolaryngol Suppl 1993;500:88-91

Capsaicin - pungent agent in hot peppers

Used for headache, sinus, and allergies for >150 years

Shown to desensitize sensory neurons1,2(peptidergic

sensory C-fibers) Nasal formulation reduces congestion of blood vessels

reduces irritation by airborne particles, allergens

rapidly relieves allergy and sinus congestion symptoms

reduces pain (i.e. headache)
http://www.biotech-weblog.com/50226711/chili.jpg


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Intranasal CapsaicinClinical Data

Capsaicin is efficacious in the treatment of non-infectious rhinitis

Blom HM, et al. Clin Exp Allergy 1997; 27:796-801

Study shows capsaicin efficacy rate of 89% in allergic rhinitis patients

Zhang F et al. Lin Chuang Er Bi Yan Hou Ke Za Zhi. 1999 Nov; 13(11): 499-500.

Capsaicin significantly reduced overall nasal symptoms, rhinorrhea

and nasal blockage

Van Rijswijk JB et al. Allergy. Aug; 58(8):754-61.

Intranasal capsaicin relieved the clinical symptoms of allergic rhinitis

and reduced the level of Substance P in the nasal secretions.

Zhang R, et al. Zhonghua Er Bi Yan Hou Ke Za Zhi.1995; 30(3):163-5


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Capsaicin improved predominate symptoms (nasal congestion,

hypersecretion, sneezing) by 62-72%, offering a promising new option

for treatment of hyper-reactive rhinopathy

Wolf G et al. Laryngorhinootologie. May;74(5):289-93

Capsaicin significantly reduced symptoms in chronic rhinitis patients

with no significant side effects

Lacroix JS et al. Clin Exp Allergy. Sep; 21(5):595-600.

Nasal obstruction and nasal secretion significantly reduced by

intranasal capsaicin

Marabini S et al. Eur Arch Otorhinolaryngol. 248(4):191-4

Capsaicin clinical data (cont.)


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Clinical Data (cont.)

The efficacy of repeated capsaicin application

has been established in several randomized

controlled trials. This treatment modality may bethe first step to more specific and better

treatment options for patients with idiopathic

rhinitis that is unresponsive to standard

treatment.

Van Rijswijk JB, et al. Curr Allergy Asthma 2006; Rep. 6(2):132-7.


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2 formulations / brands of capsaicin nasal sprayavailable in the US

Sinol-MSinusBuster

Sinol-M is a new all-natural nasal spray formulated forthe fast relief of allergies, sinus congestion andheadache

Sinol-M is the onlyall-natural remedy for allergic rhinitiswith proven clinical efficacy and tolerability1

Capsaicin nasal sprays

1. Kaliner M, et al 2009 Poster presentation at the Western Society ofAllergy Asthma and Immunology 47thAnnual Scientific session


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AVAILABLE NOW

For fast, safe, natural relief of symptoms

Sinol-M


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Sinol-M

All natural ingredients

No rebound

No harsh side effects or known interactions

Non-drowsy

Non-addictive

Can be used as needed up to 12 times per day


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ACTIVE INGREDIENTSA homeopathic dose of capsaicin - thepungent phenolic compound responsible for

the analgesic properties of hot pepperAloe Vera for its soothing effect

AND MucoAd

a novel mucoadhesive carrierto prolongadherence of the active ingredients to thenasal mucosa

Sinol-M


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Classified as a homeopathic drug

Registered by the FDA

Produced in the USA

Manufactured in an FDA-approved facility

Sinol-M


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Comparative study of 1stgeneration Sinol and thenew generation Sinol-M

Conducted at the Institute for Asthma & Allergy,(Washington, DC)

24 patients with > 2 year history of persistent

allergic rhinitis

Sinol-M clinical data

Kaliner M, et al 2009 Poster presentation at the Western Society of Allergy Asthmaand Immunology 47thAnnual Scientific session


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Crossover study1- week, run-in with no treatment, followed by 1-week of either Sinolor Sinol-M, (one spray in each nostril PRN)1-week washout (no treatment) followed by 1-week treatment with theother Sinol product

AM and PM nasal symptoms scored in diaries (scale, 0=no symptoms to4=very severe symptoms)

runny noseitchy nosecongestion

sneezing

The daily Total Nasal Symptom Score (TNSS) = AM + PM scores(min =0, max =32)

Sinol-M study design

Kaliner M, et al 2009 Poster presentation at the Western Society of Allergy Asthma

and Immunology 47th

Annual Scientific session


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Sinol-M study results

Mean Daily TNSS(sum of morning and evening scores)

TNSS scores decreased with both active treatments


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Mean daily number of sprays

Improvement in TNSS occurred despite fewer doses of Sinol-M vs. Sinol


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Both Sinol and Sinol-M significantly reducedbothersome nasal symptoms vs. no treatment

Patients used fewer doses of Sinol-M, vs. Sinol,especially at night, suggesting improved efficacy,sleep and associated Quality of Life

No treatment related side-effects observed with eitherSinol or Sinol M


Kaliner M et al .2009 Poster presentation at the Western Society of AllergyAsthma and Immunology 47thAnnual Scientific session


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Professional Marketingof Sinol-M

Sinol USA has engaged Strategic Pharmaceutical Advisors(SRxA) to handle professional marketing of Sinol-M

Retail pharmacy sales of Sinol-M will be driven by targetededucation programs for pharmacists and endorsement fromhealth care professionals:

Allergists, ENT, pulmonologists, primary care physicians, NPs, PAs

Sinol-M poster presentations and exhibits at major medicalmeetings

AAAAI, EACCI, WSAAI


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Additional formulations including Childrens Allergy, Cough & Cold

and Childrens Cough & Cold will be introduced during 2009

Si l M


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Sinol-M contains capsaicin, derived from the hot pepper plant. Uponinitial use, some patients may experience a mild burning sensation,lasting 2-5 seconds. This is transient, usually diminishes withsubsequent application.

If pregnant or breast feeding, ask a health professional before use.

Do not spray in or around the eye area. If contact occurs, rinsecopiously with water

Not recommended for children

sinol pharmacy education webinar 6-2-09.pdf

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