Thursday, July 29, 2010

News: Dulera approved

Dulera is a combination product of an inhaled corticosteroid (mometasone furoate, which is the same as Asmanex) and a long-acting bronchodilating agent (LABA) for asthma.  I've written about this earlier.  The FDA approved Merck's Dulera on June 24, 2010.  Here is the FDA's medication guide.  Dulera became the third combined product available, following Advair and Symbicort.  I was privileged to assist with the trials to approve Dulera.  I personally noted no problems, but much more importantly, the FDA did not find particular problems with Dulera.  I think it will compete in the market place with other asthma products as simply another option to treat asthma.  Note the LABA (formoterol) in Dulera is the same as in Symbicort, Foradil, Perforomist, and Brovanna. There are no comparative trials available nor planned to my knowledge.
Congratulations to Merck and asthmatics,
from your Allergy Dude

addendum: 8/12/10.  Samples were delivered to my office.  This is the only sky blue inhaler available (see photo).  There is a counter on the back side to measure the number of puffs produced from the inhaler.  The only difference between the two strengths, 100 versus 200, is the barely visible yellow label and light purple label respectively on the top of the canister.  Being environmentally conscious, I am happy to report that the propellant is HFA.  Each canister contains enough medication for 120 puffs.  Cost is unknown.  Insurance coverage is likely to be non-existent, because it typically takes about 1 year for a new medication to get on an insurance company's drug formulary and being covered at an acceptable level.  Due to my sensitivity for my patient's spending on medications, not discomfort with Dulera itself, I predict that some time will occur before I am commonly prescribing Dulera for properly indicated patients.
Your Allergy Dude

addendum: 8/20/10.  Some physicians offices may have coupons for Dulera.  The initial offer is for 1 free month's supply, meaning 1 cannister.  Both doses are being priced the same, with an AWP of $188.  The cash price at the pharmacy will be about $200 then.
Your Allergy Dude

1 comment:

Lynn Scholl said...

HFA's make my and a lot of asthmatics asthma worse! CFC's from inhalers contributed to a miniscule proportion of the total emissions compared to other sources and their removal is putting people who depended on them at risk. See: http://www.consumeraffairs.com/health/hfa_inhalers.html for more information.

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