Asthma is an inflammatory disorder of
the airways, which causes attacks of
wheezing, shortness of breath, chest
tightness, and coughing.
DULERA, AN INHALED ASTHMA
Merck & Co.'s Dulera inhaler has been
approved in June 2010 by the FDA for
people 12 and older whose asthma
isn't controlled with other medication.
Dulera combines a corticosteroid
(mometasone furoate) and a
long-acting beta agonist (formoterol
fumarate). The latter class of drug
increases the risk of asthma-related
hospitalization in children and teens,
Merck said, so Dulera should only be
used by people whose asthma isn't
adequately controlled with a different
class of drug.
FDA approval of Dulera was based on
clinical testing of 12-to-26 weeks
among 1,509 people aged 12 and
older. The most common adverse
reactions included sinus inflammation
(sinusitis) and headache.
Dulera isn't a rescue medication and
does not replace a fast-acting inhaler
to treat symptoms that begin suddenly.
Dulera is a rival for GlaxoSmithKline
Plc's market-leading Advair and
AstraZeneca Plc's Symbicort, both of
which act in a similar way.
Recently the FDA has taken a critical
look at LABA drugs, drawing up new
warnings earlier this month for the
Potential blockbusters: fluticasone
furoate, developed by
GlaxoSmithKline, in partnership with
Theravance Inc (Phase 3)
Drug in trial: RPL554 by Verona