Product
Brovana
Approval Date
October 6, 2006
Release Date
March 28, 2007
Company
Sepracor
Class
Bronchodilator (long-acting ß2-agonist)
Indication
Long-term maintenance treatment of bronchoconstriction due to COPD.
Active Ingredient
Arformoterol 15micrograms/2mL; soln for inh.
Agency Roster
ICC (Professional)
RX Mosaic Health (PR)
Marketing Strategy/Execution
Brovana represents the first long-acting bronchodilator available for patients with chronic obstructive pulmonary disease (COPD). Many COPD patients receive their bronchodilator therapy through a nebulizer, and other nebulized COPD therapies are short-acting agents. Journal ads for the twice-daily maintenance treatment alert physicians to this new possibility. The only other nebulized long-acting beta agonist is Dey’s Perforomist, also launched this year.
The Market
| Beta Agonists US sales ($000s) last 5 years | |
| 2006 |
$1,597,804 |
| 2005 |
$1,355,168 |
| 2004 |
$1,268,521 |
| 2003 |
$1,332,841 |
| 2002 |
$1,383,551 |
| Source: IMS Health, Oct. 2007 |
|
| Top 5 Beta Agonists | ||
| Jan.-July ’07 US sales ($000s) | % sales growth over Jan.-July ‘06 | |
|
XOPENEX (Sepracor) |
354,557 |
7 |
|
PROAIR HFA (Teva) |
218,729 |
761 |
|
PROVENTIL HFA (Schering-Plough) |
104,166 |
262 |
|
SEREVENT DISKUS (GSK) |
84,378 |
-14 |
|
ALBUTEROL |
82,705 |
809 |
| Source: IMS Health, Oct. 2007 |
||
Physician Outlook
Brovana (arformoterol) is a nebulized, long-acting betaagonist (LABA) launched in April 2007. It offers rapid onset of action andtwice-daily dosing. In GfK Market Measures’COPD M.D. 2007 study, fielded just three months post Brovana launch, 44% ofpulmonologists and 22% of primary care physicians indicated they are currentlyprescribing Brovana. These data compare to virtually 100% of both physicianspecialties who prescribe market leader Advair.
—Sue Ramspacher, senior VP, GfK Market Measures, November2007
Also in the Pipeline(according to Adis R&D Insight)
Drug: Serevent
Manufacturer: GlaxoSmithKline
Indication: Asthma, COPD
Active Ingredient: Salmeterol
Phase: III
Source: Wolters Kluwer Health, Oct. 2007
Recent MM&MCoverage
Productnews from the 04/17/07 news brief
Productnews from the 10/10/06 news brief
TheTop 50: Regan Campbell Ward • McCann
Nycomedfinds a US partner for asthma drug
Pharmacology
Arformoterol is the (R,R) enantiomer of formoterol, along-acting ß2-agonist. It is twice as potent as the racemicmixture. Arformoterol is a bronchodilator that relaxes bronchial smooth muscleand inhibits the release of hypersensitivity mediators from mast cells.
Clinical Trials
Two 12-week trials involving a total of 1,456 patients were conducted toestablish the safety and efficacy of arformoterol in the long-term treatment ofCOPD. Both studies compared 3 doses of arformoterol (15mcg twice daily, 25mcgtwice daily, and 50mcg once daily) to placebo, and included the use ofsalmeterol aerosol 42mcg twice daily as a comparator.
In both studies, the use of arformoterol 15mcg twice daily resultedin significantly greater post-dose bronchodilation compared to placebo. Thiseffect was maintained over 12 weeks. The use of the higher doses ofarformoterol did not result in sufficient additional benefit on severalendpoints (including FEV1). After the first 15mcg dose ofarformoterol, the median time to onset of bronchodilation (FEV1increased by 15%) occurred at 6.7 minutes, and peak bronchodilator effect wasusually seen within 1–3 hrs after dosing. Patients treated with arformoterolshowed improvements in peak expiratory flow rates and supplemental use ofipratropium and rescue albuterol use, compared to placebo. Tolerance to thebronchodilator effect was seen after 6 weeks of dosing, as shown by a decreaseby about one third in bronchodilator effect measured by FEV1.
Adverse Reactions
Asthenia, fever, bronchitis, headache, GI upset, serum K+ changes, leukocytosis, nervousness, pain, tremor, flu syndrome; cardiovascular effects (eg, increased pulse rate or BP; consider discontinuing if occurs); rarely: paradoxical bronchospasm, hypersensitivity reactions; increased risk of asthma-related death.
Adults
By nebulizer: 15micrograms by inhalation twice daily (AM & PM). Use standard jet (eg, PARI LC PLUS) nebulizer with air compressor (eg, PARI DURA-NEB 3000). Reevaluate periodically.
Children
Not recommended.
Contraindications
Not for treatment of acute attacks. Do not initiate in significantly or acutely deteriorating COPD. Concomitant other long-acting ß2-agonists.
Precautions
Do not exceed recommended dose. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertension). Convulsive disorders. Hepatic impairment. Hyperthyroidism. Hypokalemia. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Monitor potassium. Prescribe a short-acting ß2-agonist for acute symptoms; monitor for increased need. Pregnancy (Cat.C). Labor & delivery. Nursing mothers.
Interactions
See Contraindications. Avoid other sympathomimetics (except short-acting bronchodilators). Avoid use during or within 2 weeks of MAOIs, tricyclics, others that prolong QTc interval. Antagonized by ß-blockers. K+-depleting diuretics, theophylline, aminophylline, steroids may potentiate hypokalemia.
