Product
Veramyst

Approval Date
April 27, 2007
 
Release Date
May 25, 2007
 
Company
GlaxoSmithKline
 

Class

Corticosteroid
 
Indication
Seasonal and perennial allergic rhinitis.
 
Active Ingredient
Fluticasone furoate 27.5micrograms/spray; alcohol-free.
 
Agency Roster
Torre Lazur McCann (professional)
 
MarketingStrategy/Execution
Once-daily nasalspray Veramyst (fluticasonefuroate) was one of the most anticipated respiratory compounds coming out ofthe pipeline because of its ability to treat the nasal and ocularsymptoms of allergic rhinitis. The product is a successor to Flonase, which went generic in 2006. Veramysthas a broader label than Flonase, and some say the device is easier to use thantraditional inhalers. Glaxo reps who carry Veramyst in their bag will have todistinguish it from rival products with similar pharmacologicalproperties, like market leader Nasonex, if they want to persuade physicians toswitch their patients. Favorableclinical data should help. Veramyst launched nationwide ahead of allergyseason, in May 2007, generating $11.9 million in US sales as of July, according toIMS Health.

The Market

Steroid, inhaled nasal US sales ($000s) last 5 years
2006

$2,471,125

2005

$2,671,054

2004

$2,416,000

2003

$2,263,942

2002

$2,014,636

Source: IMS Health, Oct. 2007

 

Top 5 steroid, inhaled nasal
  Jan.-July ’07 US sales ($000s) % sales growth over Jan.-July ‘06

NASONEX(Schering-Plough)

585,731

15

NASACORTAQ (sanofi-aventis)

219,736

10

FLUTICASONEPROP

213,492

13

RHINOCORTAQUA (AstraZeneca)

157,869

-10

FLUTICASONEPROP (Roxane)

142,269

75
Source: IMS Health, Oct. 2007

Physician Outlook
Study planned, December

Also in the Pipeline(according to Adis R&D Insight)
No competitor compounds in Phase III or pre-registration, US

Recent MM&MCoverage
Productnews from the 05/01/07 news brief
FDAissues Flonase, Nasonex letters

Pharmacology
Fluticasone furoate is a synthetic trifluorinatedcorticosteroid with potent anti-inflammatory activity. The exact mechanism bywhich this corticosteroid exerts its effects in the treatment of allergicrhinitis is unknown. Corticosteroids have been shown to have a wide range ofactions on multiple cell types (eg, mast cells, eosinophils, neutrophils,macrophages, lymphocytes) and mediators (eg, histamine, eicosanoids,leukotrienes, cytokines) involved in inflammation.

Although significant improvement with Veramyst is usually achievedwithin 24 hours in patients with seasonal allergic rhinitis and four days inpatients with perennial allergic rhinitis, maximum benefit may not be reachedfor several days.

Clinical Trials

The efficacy and safety of Veramyst was evaluated in 5 randomized,double-blind, placebo-controlled studies of 2 to 4 weeks’ duration involving1,829 patients =12 years old with symptoms of seasonal or perennial allergicrhinitis. Assessment of efficacy was based on total nasal symptom score.Secondary efficacy variables included the total ocular symptom score (TOSS),and rhinoconjunctivitis quality of life questionnaire (RQLQ). In each study,Veramyst was shown to be more effective than placebo in relieving overall nasalallergy symptoms. In addition, 3 seasonal allergy studies showed that Veramystwas significantly better than placebo in relieving ocular symptoms and inproviding a significant and clinically meaningful improvement in overall RQLQ;these effects were not seen in the perennial allergic rhinitis trials. In allstudies, Veramyst sustained its effectiveness for a full 24 hours.

Veramyst was also shown to be effective in treating overall nasalsymptoms in children 2–11 years old with seasonal and perennial allergicrhinitis. Changes in TOSS in the seasonal allergic rhinitis trial were notstatistically significant; TOSS was not assessed in the perennial allergicrhinitis trial.

Adverse Reactions
Headache, epistaxis, nasopharyngitis, pharyngolaryngealpain, nasal ulceration, back pain, pyrexia, cough.

Adults
Initially 2 sprays in each nostril once daily. Maintenance:may reduce to 1 spray in each nostril daily.

Children
>2 years: not recommended. 2–11 years: initially 1 sprayin each nostril once daily; may increase to 2 sprays in each nostril oncedaily. Maintenance: 1 spray in each nostril once daily.

Precautions
Maintain regular regimen. Respiratory tract tuberculosis.Infection (eg, ocular herpes simplex). Severe hepatic impairment. Nasalsurgery, ulcers, or trauma (may impair wound healing). If exposed to measles orchickenpox, consider anti-infective prophylactic therapy. If adrenalinsufficiency exists following systemic corticosteroid therapy, replacementwith topical corticosteroids may exacerbate symptoms of adrenal insufficiency.Monitor for growth suppression in children. Monitor for hypercorticism and HPAaxis suppression (if occur discontinue gradually), candida infection or othernasal mucosal changes, vision changes. Avoid eyes. Pregnancy (Cat.C). Nursingmothers.

Interactions
Avoid ritonavir. Caution with potent CYP3A4 inhibitors (eg,ketoconazole).