Complementary & Alternate Medicines for Allergies & Sinus Congestion:

Making sense of the data for you and your customers

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Financial Disclosure

Dr Storms has received grants for clinical research from :

Alcon Labs, Amgen, AstraZeneca, BMS, Genentech, GSK, Johnson & Johnson, Meda, Merck, Novartis, Sanofi-Aventis, and Schering;

Has worked as an advisor for :Abbott, Alcon Labs, AstraZeneca, Consumer Reports,Critical Therapeutics, Merck, Nexcura, Novartis, Reckitt Benckiser, Sanofi-Aventis, Schering, Sepracor, TEVA, SRXA;

Has served on the speakers' bureau for :Abbott, Alcon Labs, AstraZeneca, Boehringer, Genentech, Meda, Merck, Novartis, Sanofi-Aventis, Schering, Sepracor, TEVA, TREAT Foundation, and UCB.

Introduction

Allergic rhinitis and

sinus congestion are

commonly encountered

complaints and result in

significant 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

• 2nd leading 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. Otolaryngol – HNS. 2007;136:S107-24.

Allergic Rhinitis

20% of patients believe their health care provider does not 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 for relief 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

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

Therapeutic Options

Conventional Treatment 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 as taste, sedation, rebound, costs (direct and indirect), ease of use

Relative Effectiveness of Medications used to treat allergic rhinitis

Wallace et al. J Allergy Asthma Clin Immunol 2008; 122: S1-84. Bousquet et al. Allergy 2008; 63: S8-S160.

Medication Class

Sneezing Itching Congestion Rhinorrhea Eyes Inflammation

Oral antihistamines

++ ++ +/- ++ + +

Intranasal antihistamines

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

Intranasal corticosteroids

++ ++ ++ ++ + ++

Leukotriene modifiers

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

Cromolyn sodium + + - + + +

Decongestants - - ++ - - -

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

Complementary & Alternate Medicine use (US)

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

People are increasingly using complementary and alternate medicine (CAM).

CAM use among adults is greatest among women and those with higher levels of education and income.

Complementary & Alternate (CAM) Options

1. Colloidal silver

2. Saline (drops/spray/wash)

3. Oral homeopathic substances i.e.

i. Arsenicum album

ii. Kali bichromicum

iii. Pulsatilla

iv. Luffa Operculata

v. Echinacea and Turmeric

3.

4. Capsaicin nasal spray

5. Nutritionals

i. Bromelain

ii. Quercetin

iii. Vitamin C

iv. Garlic

Limited clinical evidence for most CAMs.

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 and effective 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 allergic rhinitis or sinusitis

Luffa Operculata (Zicam)

Placebo-controlled,double-blind study of 32 pts with seasonal allergic rhinitis. Patients received Zicam or placebo 4xday / nostril for 14 days

1°endpoint was the change from baseline in the overall Rhinoconjunctivitis Quality of

Life Questionnaire (RQLQ)

4 x daily Zicam improved patient related QoL and reduced impairment in day to day activities 1st week 2nd week

0%

10%

20%

30%

40%

50%

60%

PlaceboZicam

% Baseline

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

RQLQ Scores% decrease from baseline

Nasal Saline (Drops/Spray/Wash)

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

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

Nasal saline is generally accepted as an effective 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

Capsaicin

1. Lacroix JS et alClin Exp Allergy 1991;21:595-6002. 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)

Intranasal Capsaicin – Clinical 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

Capsaicin improved psymptoms (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.)

Clinical Data (cont.)

“The efficacy of repeated capsaicin application has been established in several randomized controlled trials. This treatment modality may be the 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

2 formulations / brands of capsaicin nasal spray available in the US

Sinol-M (Sinol USA Inc.)Sinus Buster (Buster Brands Inc.)

Sinol-M is a new all-natural nasal spray formulated with a muco-adhesive and indicated for the fast relief of allergies, sinus congestion and headache

Sinol-M is the only all-natural remedy for allergic rhinitis with proven clinical efficacy and tolerability1

Capsaicin nasal sprays

1. Kaliner M, et al 2009 Poster presentation at the Western Society of Allergy Asthma and Immunology 47th Annual Scientific session

ACTIVE INGREDIENTS- a homeopathic dose of capsaicin - the pungent phenolic compound responsible for the analgesic

properties of hot pepper- Aloe Vera for it’s soothing effect

AND a novel mucoadhesive carrier – to prolong adherence of the active ingredients to the nasal

mucosa

Sinol-M

AVAILABLE NOW

For fast, safe, natural relief of symptoms

Sinol-M

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

Classified as a homeopathic drug

Registered by the FDA

Produced in the USA

Manufactured in an FDA-approved facility

Sinol-M

Comparative study of 1st generation Sinol and the new 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 Asthma and Immunology 47th Annual Scientific session

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

AM and PM nasal symptoms scored in diaries (scale, 0=no symptoms to 4=very severe symptoms)

runny nose itchy nose congestion 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

Sinol-M study results

Sinol Sinol-M02468

101214161820

Run-in Treatment

TN

SS

Sco

re (

Min

. =

0 /

Max

. =

32)

P=0.001 P=0.001

Mean Daily Total Nasal Symptom Score (sum of morning and evening scores)

TNSS scores decreased with both active treatments

Sinol-M study results

Mean daily number of sprays*

Sinol Sinol-M0

0.20.40.60.8

11.21.41.61.8

AM PM

Nu

mb

er o

f S

pra

ys

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

*patients were allowed to used the product on a PRN basis up to 12 x / day

Both Sinol and Sinol-M significantly reduced bothersome 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 either Sinol or Sinol M

Sinol-M study results

Kaliner M et al .2009 Poster presentation at the Western Society of Allergy Asthma and Immunology 47th Annual Scientific session

Professional Marketing of Sinol-M

Sinol USA has professional marketing of Sinol-M

Retail pharmacy sales of Sinol-M will be driven by targeted education programs for pharmacists and endorsement from health care professionals:

Allergists, ENT, pulmonologists, primary care physicians, NP’s, PA’s

Sinol-M poster presentations and exhibits at major medical meetings

AAAAI, EACCI, WSAAI

Additional formulations including Children’s Allergy, Cough & Cold have been introduced for 2011

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

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

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

Not recommended for children <12

Please see pack insert for complete instruction for use

Sinol-M Important Information

Need more information or have any clinical questions?

Send an email to info@sinolUSA.com

Or www.sinolUSA.com

800-632-2824 or 203-270-7755

Sinol-M Ask-the-experts