GSK's Flonase Sensimist (Veramyst) Switches Name On Way To OTC

GSK gains approval of sNDA for Rx Veramyst (fluticasone furoate/spray) to be marketed OTC as Flonase Sensimist, an extension of the Flonase Allergy Relief.

Fluticasone furoate will reach the US OTC market as Flonase Sensimist Allergy Relief following FDA's recent FDA approval of GlaxoSmithKline PLC's supplemental new drug application to market its previously Rx product Veramyst (fluticasone furoate/0.0275mg metered spray) over-the counter.

Flonase Sensimist is planned for a 2017 first-quarter launch in the US and Puerto Rico by GlaxoSmithKline Consumer Healthcare LP, theGlaxo and Novartis AG joint venture marketing the firms' OTC drugs and nutritional products. It will be marketed as an extension of the Flonase Allergy Relief line launched in 2014, an unusual strategy in OTC switches that aims to build on the greater brand recognition for Flonase than for Veramyst.

The Sensimist product shares an indication with Flonase Allergy– once-daily use for temporary relief of nose- and eye-related allergy symptoms. But while Flonase Allergy (fluticasone propionate/0.05mg) is approved for use in children age 4 and up, the lower dose Flonase Sensimist is approved for children age 2 and up.

The switch sNDA was approved Aug. 3, following submission in October 2015. Rx Veramyst was approved in 2007 for treatment of symptoms of seasonal and perennial allergic rhinitis in adults and children age 2 and older. Multiple changes or additions have been made since to contraindications and warnings on Veramyst labeling, but no further revisions were made as part of the switch approval.

Different formulations of fluticasone will remain available by prescription in GSK's Ellipta product line for treating asthma and chronic obstructive pulmonary disease.

Twist On Typical Switch Branding

OTC switches typically use the same brand as the original prescription product, or a variation of it, leveraging a ready marketing platform that consumers familiar with an Rx brand can follow to the nonprescription market.

GSK Consumer Healthcare didn't have that advantage as it moves Veramyst out of Rx in a full switch and prepares to launch it OTC as Flonase Sensimist.

Flonase is "a brand that consumers love and they're very familiar with." – GSK's Amardeep Kahlon

With the Flonase brand, GSK Consumer Healthcare has a brand platform with a stronger Rx history than Veramyst, says Amardeep Kahlon, director of marketing.

"One of the key factors in this is that Veramyst wasn't widely available formerly as an Rx. It wasn’t as widely available as, say Flonase was in its heyday," he said in an interview.

Marketing for the product will start from "building on the momentum of [the original] Flonase launch, just building from that," Kahlon added. "It's a brand that consumers love and they're very familiar with. Obviously it had a big heritage from the prescription side of the market. … I think it carried it over its awareness from the Rx into the OTC market."

FDA has cautioned drug firms about assigning similar brands to products that contain different active ingredients. (Also see "Umbrella Branding Is ‘Particular Concern’ As FDA Requests Research Proposals" - Pink Sheet, 13 Aug, 2015.) However, with Veramyst marketed Rx with an indication similar to OTC Flonase Allergy and with the products containing different moieties of the same steroidal backbone, the agency did not object to extending the Flonase brand with a fluticasone furoate product.

Adding Flonase Sensimist to its offerings was part of GSK Consumer Healthcare's plan for the OTC Flonase brand from the start to help differentiate it in the OTC intranasal corticosteroid space, Kahlon said.

"It was part of our thinking at the time when we were making the original launch. Because it's important with the amount of activity and the competition that we keep finding ways to innovate," he said.

Pressure From Other OTC Brands

The two other metered-spray products that pioneered the OTC use of intranasal corticosteroid ingredients – Sanofi's Nasacort Allergy 24HR (triamcinolone acetonide/0.055mg) and Rhinocort Allergy Relief (budesonide/0.032mg), marketed by McNeil Consumer Healthcareunder license from innovator AstraZeneca PLC– also built on Rx brand equity. (Also see "Rhinocort Switch Makes Three In OTC Intranasal Corticosteroid Market" - Pink Sheet, 26 Mar, 2015.)

In addition to Nasacort and Rhinocort, Flonase Allergy competes with an equivalent formulation, Bayer HealthCare LLC's ClariSpray launched in April. However, among OTC fluticasone propionate sprays, Flonase Allergy has exclusivity through July 23, 2017, for an indication of “OTC use for temporary relief of ocular symptoms due to hay fever or other upper respiratory allergies,” according to FDA's Orange Book. (Also see "Bayer's ClariSpray Brings Hint Of Familiar Brand To Nasal Allergy Space" - Pink Sheet, 30 May, 2016.)

GSK Consumer Healthcare said FDA has not yet advised the firm whether Flonase Sensimist will have market exclusivity for its formulation or claim.

Kahlon pointed out that Flonase Sensimist's active ingredient is a different isomer of fluticasone and its dosage is smaller than Flonase Allergy. "You need less of the drug to create the same effect," he said.

A respiratory disease expert from GSK's research facility in Hertfordshire, England, published a July 2011 letter in the Clinical Respiratory Journal stating that research shows fluticasone furoate confers higher affinity than fluticasone propionate for both nasal and lung tissue, contributing to evidence that it may result in superior symptom reduction.

Additionally, according to a study published in 2010 from a 360-subject trial, patients preferred fluticasone furoate to fluticasone propionate based on attributes of scent or odor, 60% to 18%; aftertaste, 59% to 21%; leaking from the nose and in the throat, 59% to 21%; and mist gentleness, 57% to 26%. The study in the Annals of Allergy, Asthma & Immunology did not show statistically significant differences in preferences regarding ease of use, delivery method, or device comfort.

GSK Exclusive In Fluticasone Furoate Rx

Moving Veramyst entirely to OTC doesn’t mean Glaxo is abandoning the Rx fluticasone furoate market, though.

According to FDA's NDA database, the UK pharma sustains its exclusivity in the space with the Ellipta line of inhalation powder products: Arnuity, in 0.1mg and 0.2mg dosages, indicated for asthma treatment as a prophylactic therapy for patients age 12 and older, and Breo, 0.1mg with vilanterol trifenatate/0.025mg, a long-acting beta-agonist, indicated for maintenance treatment airflow obstruction in COPD patients, for reducing exacerbations of the condition and for once-daily asthma treatment for patients 12 and older.

FDA approved GSK's NDA for Arnuity in August 2014. (Also see "In Brief: GSK, Bristol/Pfizer See Approvals, Baxter Holds Its Own in Hemophilia" - Pink Sheet, 25 Aug, 2014.) In March 2015, the agency approved the firm's “Changes Being Effected” supplemental NDA to revise the carton and container labels to include lactose monohydrate for both dosages; change the color of the 0.2mg dosage from green to orange and yellow; and add several minor editorial changes, according the agency's approval letter.

The Breo NDA was approved in 2013 for COPD indications and the asthma indication was added in February 2016 following an advisory committee meeting on the efficacy and safety results of the product in 12- to 17-year-old patients.

From the editors of the Tan Sheet.