| |
Home »
Market Intelligence »
Tigecycline offers new hope in the
battle against MRSA
Tigecycline offers new hope in the battle against MRSA
Study data presented at a major recent
conference has demonstrated that Wyeth's novel
antibacterial
tigecycline acts against drug-resistant pathogens in some serious bacterial
infections, including MRSA. While Wyeth
will have to work hard to establish tigecycline in this competitive area, its
encouraging tolerability profile could give it a useful advantage over existing
treatments.
Tigecycline offers new hope in the battle against MRSA
Tigecycline offers new hope in the battle
against MRSA
(Date of publication 26 November 2004)
Study data
presented at a major recent conference has demonstrated that Wyeth's novel
antibacterial tigecycline acts against drug-resistant pathogens in some serious
bacterial infections, including
MRSA. While Wyeth
will have to work hard to establish tigecycline in this competitive area, its
encouraging tolerability profile could give it a useful advantage over existing
treatments.
US pharmaceuticals company Wyeth presented a range of
clinical data at the 44th Interscience Conference on Antimicrobial Agents and
Chemotherapy (ICAAC) in October, including Phase III data from a clinical trial
in patients with complicated intra-abdominal infections and from another in
complicated skin and soft tissue infections (cSSI). The first trial, which
compared tigecycline to Merck & Co's carbapenem Primaxin
(imipenem/cilastin), found that a twice-daily dose of tigecycline was
non-inferior to a comparable regime of Primaxin. In addition, adverse events
occurred as often with Primaxin as with tigecycline, with the most common being
gastrointestinal in nature.
The tigecycline 305 cSSI trial compared
50mg of tigecycline, taken twice daily after an initial loading dose of 100mg,
to a twice daily regimen of 1g vancomycin combined with 2g of aztreonam.
Tigecycline was again found to be non-inferior to the comparator regime
demonstrating a lower incidence of serious side effects, in particular raised
alanine aminotransferase and aspartate aminotransferase levels.
In
addition to the Phase III trial data presented, Wyeth also provided details of
a number of in vitro resistance studies. The Tigecycline Evaluation
Surveillance Trial (TEST) examined the activity of the drug against a number of
resistant strains of bacteria, including methicillin susceptible staphylococcus
aureus (MSSA) and methicillin resistant staphylococcus aureus (MRSA). One study
found that tigecycline had good activity against clinical strains of
community-acquired MRSA and multi-drug resistant MRSA. Furthermore, oxacillin
resistant strains of staphylococcus aureus (ORSA) were also susceptible to
tigecycline.
New treatment option
The development of
tigecycline, the first in the novel glycylcycline class, has provided a new
option in the ongoing fight against resistant pathogens, particularly in severe
or hospital treated infections. Although the drug's efficacy against resistant
strains of bacteria is a key advantage, Professor Peter Hawkey, Professor of
Public Health Bacteriology at the
West Midlands Public Health Laboratory, commented that its tolerability profile
would also help to position it favorably.
Currently, there are several
injectable antibacterials available for the treatment of resistant infections,
such as Pfizer's Zyvox (linezolid), King Pharmaceutical's Synercid
(quinupristin/dalfopristin) and Cubist's recently approved Cubicin
(daptomycin). However, there are a variety of adverse effects associated with
these drugs, for example the development of myelosuppression with the prolonged
use of Zyvox. Professor Hawkey believes that this will ensure tigecycline will
not only establish itself in the treatment of severe infections, but may also
lead to it being used instead of some of the already available narrow-spectrum
drugs.
Recent Datamonitor research found that some of the newer, novel
antibacterials acting against drug-resistant pathogens tend to be reserved for
use when other options have been exhausted. There are several reasons for this,
but primarily it is due to the need to protect against the development of
resistance to these products. With so few drugs in the antibacterials pipeline,
especially with activity against gram-negative bacteria, physicians are wary of
shortening the useful life of newly launched drugs through premature resistance
development.
The future use of tigecycline
A second
reason is often the cost of the drugs, with many commanding a premium price
point due to the sizeable unmet need and their use in niche markets. However,
Professor Hawkey commented that, in reality, the cost-effectiveness of these
drugs is comparable to some other antibacterials, since associated costs, such
as longer hospitalization and additional nursing time, are reduced through the
drugs' rapid efficacy.
In a partial reflection of these concerns,
recent Datamonitor key opinion leader research in the seven major
pharmaceutical markets found there were mixed opinions regarding the future use
of tigecycline in the hospital antibacterial market: "It's about the only
gram-negative that's actually offering anything new just now, and even that is
marginal," one opinion leader commented.
In an increasingly crowded
market, Wyeth will have to strategically position tigecycline to ensure maximum
uptake in the hospital treatment market. Products such as Zyvox, which offers
the advantage of an IV/oral switch option enabling earlier discharge from
hospital, are already established in this segment and real benefits will have
to be demonstrated by tigecycline to encourage physicians to switch. However,
the data presented at the 44th ICAAC has gone some way towards establishing the
drug's utility in complicated bacterial infections. Subsequent studies could be
crucial in cementing that position.
Disclaimer
Net Media Marketing excludes any
warranty, express or implied, as to the quality, accuracy, timeliness,
completeness or fitness for a particular purpose of this briefing. Net Media
Marketing will not be liable for any claims, penalties, losses, damages, costs,
or expenses arising from the use of or inability to use this briefing or from
any unauthorised access to or alteration of the Briefing. Net Media Marketing
makes no warranty that the contents of this briefing are compatible with all
computer systems and browsers.
All jobs &
Vacancies, Pharmaceutical
sales jobs, Healthcare sales
jobs, Laboratory sales jobs,
Veterinary sales jobs,
Dental sales jobs,
Trainee
medical sales jobs, Nurse Advisor
jobs, Sales Management
jobs, Marketing
jobs, Senior Management
jobs, Regulatory &
Clinical jobs, Scientific Sales
Jobs, Pharmaceutical jobs,
Pharmaceutical Company,
British National Formulary,
Medical & Pharmaceutical sales
books
|
