FDA approves Flonase allergy relief for sale over-the-counter in the United States

No. 1 prescribed allergy treatment ingredient1 to be available OTC

Issued: London UK & Parsippany, US

No. 1 prescribed allergy treatment ingredient1 to be available OTC

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) has approved Flonase® Allergy Relief (fluticasone propionate 50 mcg spray), containing the No. 1  prescribed allergy treatment ingredient1, as an over-the-counter (OTC) treatment for temporary relief of the symptoms of hay fever or upper respiratory allergies.2

Flonase® Allergy Relief is the first and only over-the-counter nasal spray indicated for relief of all nasal and eye-related allergy symptoms3,4 including runny nose, sneezing, itchy nose5-7, nasal congestion8-11 and itchy and watery eyes.12-15Flonase® Allergy Relief will be available at full prescription strength and to provide 24-hour non-drowsy allergy relief.

Roughly 50 million people in the United States suffer from nasal allergies16, and allergies take a toll on sufferers:

  • Nasal allergies can lead to fatigue, sleep disturbances, learning and attention problems and impaired function at work and/or school.17
  • In 2010, Americans with allergic rhinitis (AR)  spent approximately $17.5 billion on health- related costs, lost more than 6 million work and school days and made more than 16 million visits to the doctor.18
  • 70 percent of sufferers treat their symptoms19; however, 50 percent report they are not completely satisfied with their current method of treatment.20

No other intra-nasal hay fever and allergy treatment has been proven more effective than Flonase® Allergy Relief,1,8 a once-a-day nasal spray which helps relieve inflammation to provide 24-hour non-drowsy symptom relief.21,22Fluticasone propionate, the active ingredient in Flonase® Allergy Relief, has helped more allergy sufferers than any other nasal spray and has a well-established safety profile with 30 million accumulated patient years since it was first approved as a prescription medicine in 1994.23

Colin Mackenzie, President of Consumer Healthcare North America at GSK, said, “With the significant number of allergy sufferers in the United States and a considerable number of those unsatisfied with their current treatments, we believe the wide availability of Flonase® Allergy Relief over-the-counter is great news for these individuals. GSK has a strong heritage—40 years— in discovering and developing respiratory treatments used by patients worldwide.  We are proud of our track record of successful Rx-to-OTC switches which over the years have significantly improved access to important medicines for our consumers.”

“This approval will bring Flonase® Allergy Relief to consumers in a convenient way at the same dosage strength as found in prescription Flonase. For those with allergies, being able to find simple, effective relief over the counter may mean the difference between a day lost to allergies and a day enjoying their favorite activities,” said Dr. Vidhu Bansal-Dev, Vice President, Research and Development, GSK.

Flonase® Allergy Relief will be available over-the-counter in early 2015.

To learn more, visit www.Flonase.com for information and to sign up for allergy updates, allergy tips and special savings.

About Allergies

Symptoms of nasal allergies (allergic rhinitis) include sneezing, congestion, runny nose; itchy or sore throat, post-nasal drip and cough; and red, itchy watery eyes.24 Allergy symptoms can leave sufferers feeling irritable, breathless, sleepless and fatigued.25,26

About Flonase Allergy Relief

Flonase® Allergy Relief (fluticasone propionate 50 mcg spray) is an approved over-the-counter (OTC) treatment for hay fever symptoms including nasal congestion, runny nose, sneezing, itchy nose and itchy, watery eyes in the United States.

Fluticasone propionate has been available over the counter in the UK for over 10 years under the brand name Flixonase, and subsequently as Pirinase. The product is also available over the counter in 11 other markets including Australia and in China where it is the number one corticosteroid nasal spray.

GlaxoSmithKline Consumer Healthcare - is one of the world’s largest over-the-counter consumer healthcare products companies. Its more than 30 well-known brands include the leading smoking cessation products, Nicorette® and NicoDerm®CQ®, as well as many medicine cabinet staples -- Aquafresh®, Sensodyne®, and TUMS® – which are trademarks owned by and/or licensed to GlaxoSmithKline Group of Companies.

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com. 

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2013.

References

1.     Sur D, et al. Treatment of Allergic Rhinitis. American Family Physician.  Volume 81, Number 12, June 15, 2010.

2.     Statement of fact

3.     Greiner AN, Hellings PW, Rotiroti, G, and Scadding, GK. Allergic Rhinitis. The Lancet. 2011; 378(9809): 2112-2122.

4.     Wallace DV, Dykewicz MS, Bernstein DI, Blessing-Moore, J. et al. The Diagnosis and Management of Rhinitis: An Updated Practice Parameter. Journal of Allergy and Clinical Immunology. 2008; 122(2 SUPPL.): S1-S84.

5.     Nathan RA, Bronsky EA, Fireman P, Grossman J et al. Once Daily Fluticasone Propionate Aqueous Nasal Spray Is an Effective Treatment for Seasonal Allergic Rhinitis. Annals of Allergy. 1991; 67(3): 332-338.

6.     Banov CH, Woehler TR, LaForce C F, Pearlman DS et al. Once Daily Intranasal Fluticasone Propionate Is Effective for

Perennial Allergic Rhinitis. Annals of Allergy. 1994; 73(3): 240-246.

7.     Dykewicz MS, Kaiser HB, Nathan RA, Goode-Sellers S et al. Fluticasone Propionate Aqueous Nasal Spray Improves

Nasal Symptoms of Seasonal Allergic Rhinitis When Used As Needed (Prn). Annals of Allergy, Asthma and Immunology. 2003; 91(1): 44-48.

8.     Scadding GK, Lund VJ, Jacques LA, and Richards DH. A Placebo-Controlled Study of Fluticasone Propionate Aqueous Nasal Spray and Beclomethasone Dipropionate in Perennial Rhinitis: Efficacy in Allergic and Non-Allergic Perennial Rhinitis. Clinical and Experimental Allergy. 1995; 25(8): 737-743.

9.     Van As A, Bronsky EA., Dockhorn  RJ, Grossman J et al. Once Daily Fluticasone Propionate Is As Effective for

Perennial Allergic Rhinitis As Twice Daily Beclomethasone Diproprionate. Journal of Allergy and Clinical Immunology. 1993;  91(6): 1146-1154.

10.   GSK: Result Summary for Study FNM40184. Http://Www.Gsk-Clinicalstudyregister.Com/. 2005, 12-19.

11.   Ratner PH, Howland III WC, Jacobs RL, Reed  KD et al. Relief of Sinus Pain and Pressure With Fluticasone Propionate

Aqueous Nasal Spray: A Placebo-Controlled Trial in Patients With Allergic Rhinitis. Allergy and Asthma Proceedings. 2002; 23(4): 259-263.

12.   Haye R. and Gomez EG. A Multicentre Study to Assess Long-Term Use of Fluticasone Propionate Aqueous Nasal

Spray in Comparison With Beclomethasone Dipropionate Aqueous Nasal Spray in the Treatment of Perennial Rhinitis. Rhinology. 1993;  31(4): 169-174.

13.   Bernstein DI, Levy AL, Hampel FC, Baidoo CA et al. Treatment With Intranasal Fluticasone Propionate Significantly

Improves Ocular Symptoms in Patients With Seasonal Allergic Rhinitis. Clinical and Experimental Allergy. 2004; 34(6): 952-957.

14.   DeWester J, Philpot EE, Westlund RE, Cook CK et al. The Efficacy of Intranasal Fluticasone Propionate in the Relief of

Ocular Symptoms Associated With Seasonal Allergic Rhinitis. Allergy and Asthma Proceedings. 2003; 24(5): 331-337.

15.   GSK: Result Summary for Study FNM30034. Http://Www.Gsk-Clinicalstudyregister.Com/. 2005; 5-12.

16.   American College of Allergy, Asthma and Immunology: Allergy facts. Available at http://www.acaai.org/allergist/news/Pages/Allergy_Facts.aspx. Accessed July 2014.

17.   American College of Allergy, Asthma and Immunology: Allergic diseases and cognitive impairment. Available athttp://www.acaai.org/allergist/allergies/Types/rhinitis/Pages/allergic-diseases-cognitive-impairment.aspx. Accessed July 2014.

18.   Academy of Allergy and Asthma in Primary Care: National impact of allergies. Available at http://www.aaapc.us/wp-content/uploads/2013/01/National-Impact-of-Allergies.pdf. Accessed July 2014.

19.   Scadding G, Punekar Y. EAACI 2006, Abstract 742. (data on file).

20.   New Survey Reveals Many Patients Want More from Their Allergy Medication. Asthma and Allergy Foundation of America. Available at: www.aafa.org/display.cfm?id=7&sub=92&cont=529. Accessed April 24, 2014.

21.   GlaxoSmithKline. Data on file. 2013

22.   Oxymetazoline HCl-menthol nasal. WebMD website. http://www.webmd.com/drugs/drug-20236-Oxymetazoline+HCl-Menthol+Nasal.aspx?drugid=20236&drugname=Oxymetazoline+HCl-Menthol+Nasal. Accessed May 20, 2014.

23.   GlaxoSmithKline. Data on file. 2013

24.   Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000813.htm. Accessed April 23, 2014.

25.   Baiardini I, Braido F, Tarantini F, et al. ARIA-suggested drugs for allergic rhinitis: what impact on quality of life? A GA2LEN review. Allergy. 2008;63(6):660-9.

26.   Reilly MC et al. Clin Drug Invest 1996; 11: 278–288. (data on file).