Verification Information.

Children playing in water sprinkler

The substantiation for the claim: 'The UK's No.1 allergy relief tablet' is summarised in the table below. The claim refers to Piriteze Allergy Relief Tablets. The table gives the number of packs sold (unit sales), in the UK, for Piriteze tablets during the 12-week and one-year period to week ending 28/12/19.

Brand Format Latest 12 Months Latest 12 Weeks
PIRITEZE TABLETS 3,981,668.8 350,207.5
PIRITON TABLETS 1,396,697.8 221,901.7
ALLACAN TABLETS 1,193,089.0 134,840.9
CLARITYN TABLETS 1,160,283.0 87,980.5
BELLS TABLETS 1,000,043.2 92,695.3

Source: Nielsen Scantrack Data Total Coverage GB, Unit Sales. WE 28.12.19

CHGBI/CHPIRI/0025/20

The substantiation for the claim: 'The UK's No.1 selling allergy care brand’ is summarised in the table below. The table gives the number of packs sold (unit sales), in the UK, for the whole Piri range (Pirinase, Piriton, Piriteze and PiriNatural) during the 12-week and one-year period to week ending 28/12/19.

Brand Latest 12 Months Latest 12 Weeks
PIRI 7,675,870.0 835,860.0
BECONASE 1,762,581.6 126,603.7
BENADRYL 1,298,972.0 115,724.8
ALLACAN 1,193,089.0 134,840.9
CLARITYN ALLERGY 1,160,877.0 87,981.5

Source: Nielsen Scantrack Data Total Coverage GB, Unit Sales. WE 28.12.19

CHGBI/CHPIRI/0025/20

Top Parity Claims

Claim Verification Information for Pirinase Hayfever Relief for Adults 0.05% Nasal Spray and Pirinase Allergy 0.05% Nasal Spray

The UK Codes of Non-broadcast and Broadcast Advertising (the CAP and BCAP Codes) require that advertisers provide sufficient information, about comparisons with identifiable competitor products, to enable consumers to check the comparison for themselves.

GSK is currently using the following claims on various Pirinase promotional materials, which are supported by the below information.

‘No spray is stronger for hayfever relief, including itchy & watery eyes’ and ‘No spray is stronger for treating allergy symptoms’ for Pirinase Hayfever Relief for Adults 0.05% Nasal Spray and Pirinase Allergy 0.05% Nasal Spray

‘No spray is stronger for preventing or treating allergy symptoms’ for Pirinase Allergy 0.05% Nasal Spray.

Introduction

Pirinase Hayfever Relief for Adults 0.05% Nasal Spray and Pirinase Allergy 0.05% Nasal Spray contain fluticasone propionate, a once daily intranasal corticosteroid.

Pirinase Hayfever Relief for Adults 0.05% Nasal Spray is indicated for the relief of allergic rhinitis, such as hay fever symptoms.1

Pirinase Allergy 0.05% Nasal Spray is indicated for the for the prevention and relief of allergic rhinitis, such as hay fever symptoms,2.

Supporting data

To support the above claims, GSK reviewed all medicines with an allergy relief and/or prevention indication in a spray format available without prescription in the UK.

There are a range of Hay fever relief actives available in spray format without prescription that can be used to relieve and/or prevent the symptoms of hay fever, including nasal decongestants and other intranasal corticosteroids.

Medicines indicated for allergy relief in a spray format were identified using a number of sources including eMC3, MHRA database4 and PAGB OTC Handbook5.To ensure that only non‐prescription products were included, the legal classification of the product was determined using eMC3.

The results of the searches can be found in table 1.
Maximum doses for the active ingredients are detailed in Table 2, using information available in the Association of the European Self‐Medication Industry (AEGSP) database6 for OTC ingredients and the MHRA’s list C7, which was archived in Dec 2014.

Table 1: OTC Medicinal Sprays available for relief and/or prevention of Hayfever or allergy symptoms

Brand Licence Holder Active Strength
Boots Hayfever Relief For Adults 50mcg/Dose Nasal Spray The Boots Company PLC Beclometasone Dipropionate 50 mcg /100 microlitre (0.05% w/v)
Benacort 64 Micrograms Nasal Spray Mcneil Products Limited Budesonide 64mcg/spray
Benacort 64 Micrograms Nasal Spray Mcneil Products Limited Budesonide 64mcg/spray
Beconase Hayfever Relief For Adults 0.05% Nasal Spray Omega Pharma Beclometasone Dipropionate 50 mcg /100 microlitre (0.05% w/v)
Beconase Hayfever Omega Pharma Beclometasone Dipropionate 50 mcg /100 microlitre (0.05% w/v)
Clarinaze Allergy Control 0.05% Nasal Spray Bayer Consumer Healthcare Mometasone Furoate 0.05%
Pirinase Hayfever Relief Nasal Spray 0.05% Glaxosmithkline Consumer Healthcare Fluticasone Propionate 0.05%
Pirinase Hayfever Relief Nasal Spray 0.05% Glaxosmithkline Consumer Healthcare Fluticasone Propionate 0.05%
Nasobec Nasal Spray 50 Microgram Teva Uk Limited Beclomethasone Dipropionate 50 mcg/spray
Boots Allergy Relief 50 Microgram Nasal Spray Teva Uk Limited Fluticasone Propionate 50 mcg /100 microlitre (0.05% w/v)
Manx Healthcare Clear Nose Spray Manx Healthcare Limited Xylometazoline Hydrochloride 0.1%
JML Hayfever Relief For Adults 50 Micrograms/Dose Nasal Spray Ayrton Saunders Limited Fluticasone Propionate 0.05%
Ennogen Beclometasone Aqueous Nasal Spray 50mcg/Spray Ennogen Pharma Limited Beclomethasone Dipropionate 50 mcg/spray
Flixonase Allergy Nasal Spray 0.05%W/W Glaxosmithkline Consumer Healthcare (Uk) Trading Limited Fluticasone Propionate 0.05% w/v
Flixonase Allergy Nasal Spray 0.05%W/W Glaxosmithkline Consumer Healthcare (Uk) Trading Limited Fluticasone Propionate 0.05% w/v
GlaxoSmithKline Fluticasone Propionate Nasal Spray 50 Micrograms/Actuation Glaxosmithkline Consumer Healthcare (Uk) Trading Limited Fluticasone Propionate 0.05% w/v
GlaxoSmithKline Fluticasone Propionate Nasal Spray 50 Micrograms/Actuation Glaxosmithkline Consumer Healthcare (Uk) Trading Limited Fluticasone Propionate 0.05% w/v
Otrivine Adult Nasal Spray 0.1% W/V GlaxoSmithKline Consumer Healthcare (Uk) Trading Limited Xylometazoline Hydrochloride 0.1% w/v
Otrivine Adult Nasal Spray 0.1% W/V GlaxoSmithKline Consumer Healthcare (Uk) Trading Limited Xylometazoline Hydrochloride 0.1% w/v
Otrivine Congestion Relief Nasal Spray 0.1% GlaxoSmithKline Consumer Healthcare (Uk) Trading Limited Xylometazoline Hydrochloride 0.1% w/v
Otrivine Congestion Relief Nasal Spray 0.1% GlaxoSmithKline Consumer Healthcare (Uk) Trading Limited Xylometazoline Hydrochloride 0.1% w/v
Otrivine Adult Menthol Nasal Spray 0.1%W/V GlaxoSmithKline Consumer Healthcare (Uk) Trading Limited Xylometazoline Hydrochloride 0.1% w/v
Otrivine Adult Menthol Nasal Spray 0.1%W/V GlaxoSmithKline Consumer Healthcare (Uk) Trading Limited Xylometazoline Hydrochloride 0.1% w/v
Otrivine Adult Measured Dose Sinusitis Spray 1mg/10ml GlaxoSmithKline Consumer Healthcare (Uk) Trading Limited Xylometazoline Hydrochloride 0.1% w/v
Otrivine Adult Measured Dose Sinusitis Spray 1mg/10ml GlaxoSmithKline Consumer Healthcare (Uk) Trading Limited Xylometazoline Hydrochloride 0.1% w/v
Astepro Nasal Spray 0.15% Mylan Products Limited Azelastine Hydrochloride 0.15%

Table 2 – Maximum OTC doses of Identified Active Ingredients

Active Ingredient Max. OTC Strength Available
Azelastine Hydrochloride 0.15%
Beclometasone dipropionate 50mcg/spray
Budesonide 64mcg/spray
Fluticasone propionate 0.05%
Mometasone furoate 0.05%
Xylometazoline hydrochloride 0.1%

Conclusion

Based on the information presented in this document, there is no product available over the counter which is stronger than Pirinase Hay Fever Relief for Adults 0.05% Nasal Spray and Pirinase Allergy 0.05% Nasal Spray for the relief and/or prevention of allergy and hay fever symptoms.

This is supported by a significant data review capturing Pharmacy only and GSL medicines indicated for allergy relief and reviewing the quantities of the active ingredients in the products meeting the maximum dose as outlined by AEGSP and the MHRA’s list C, which was archived in Dec 2014.

From this data, GSK believe that the above claims are adequately supported.

References

  1. Pirinase Hayfever Relief for Adults 0.05% Nasal Spray SPC 
    https://www.medicines.org.uk/emc/product/5116/smpc. Accessed June 2019
  2. Pirinase Allergy 0.05% Nasal Spray SPC 
    https://www.medicines.org.uk/emc/product/4502/smpc. Accessed June 2019
  3. Medicines.co.uk. Accessed June 2019.
  4. MHRA RAMA XL Database. Allergy Relief/Prevention Products. Accessed June 2019. 
    https://services.intralinks.com/
  5. PAGB OTC Handbook 2019. Accessed June 2019
  6. Association of the European Self‐Medication Industry (AEGSP) database. Accessed June 2019
  7. List C. MHRA Archive. Accessed June 2019

CHGBI/CHPIRI/0076/19