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FDA Approves MiddleBrook's Amoxicillin PULSYS For Pharyngitis/Tonsillitis In Adolescents And Adults
MiddleBrook
Pharmaceuticals, Inc. (Nasdaq: MBRK), a pharmaceutical company focused on
developing and commercializing novel anti-infective products,
announced that it has received approval of its New Drug Application (NDA)
from the U.S. Food and Drug Administration (FDA), for its once-daily
MOXATAG(TM) Tablets 775 mg (amoxicillin extended-release tablets) for the
treatment of adults and pediatric patients 12 years and older with
pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes
(commonly referred to as strep throat).
The FDA approval was based on results from a Phase 3 clinical study
conducted with more than 600 patients that found once-daily MOXATAG for 10
days was effective in eradicating bacteria responsible for strep throat and
demonstrated statistical non-inferiority to a four times daily dose of
penicillin for 10 days. MOXATAG was very well tolerated in the clinical
trial.
"We are extremely gratified to have received FDA approval of our
MOXATAG NDA," stated Edward Rudnic, Ph.D., president and CEO of
MiddleBrook. "As the first and only once-daily amoxicillin therapy approved
for marketing in the United States, we believe MOXATAG represents a major
advance for patients and doctors seeking safe, effective, and convenient
treatment options for strep throat. We now look forward to continuing our
ongoing strategic evaluation process from a position of greater strength
with this approval in hand."
In accordance with the requirements of the Pediatric Research Equity
Act, MiddleBrook has agreed with the FDA to further evaluate its MOXATAG
product candidate for pediatric patients less than 12 years of age with
pharyngitis and/or tonsillitis as part of a post-marketing commitment. The
Company has agreed to submit a completed study report and data set for
MOXATAG in pediatric patients less than 12 years old within the next five
years as part of this commitment.
"Compared to four times daily penicillin, once-daily MOXATAG has shown
comparable efficacy and tolerability in eradicating Group A streptococcal
infections of the pharynx. However, the once-daily dosing of MOXATAG is a
major advantage," said lead study investigator Stan L. Block, M.D.,
professor of clinical pediatrics at the Universities of Louisville and
Kentucky Medical Schools. "For the first time, physicians in the U.S. have
the option of an FDA-approved once-daily amoxicillin therapy to treat their
adolescent and adult patients with pharyngitis/tonsillitis. This should
ensure better first- line therapy compliance with a penicillin class of
antibiotic."
Clinical Trial Results Summary
The approval of MOXATAG was based on MiddleBrook's Phase 3 clinical
study of more than 600 adults and pediatric patients 12 years and older in
a double- blind, double-dummy, randomized, parallel-group, 50-center
non-inferiority trial. The Company compared its MOXATAG tablet for the
treatment of pharyngitis/tonsillitis due to Streptococcus pyogenes (Group A
streptococcus) delivered in a once-daily, 775 milligram tablet for a period
of 10 days to 250 milligrams of penicillin dosed four times daily, for a
total of one gram per day, for 10 days.
Bacteriological eradication at the post-therapy test-of-cure visit in
the per-protocol population was 85.0 percent (198/233) of patients with
MOXATAG and 83.4 percent (191/229) with penicillin. These results
demonstrate statistical non-inferiority (95 percent confidence interval of
-5.1, 8.2). The per-protocol patient population included patients with
confirmed Group A streptococcal infections, who were compliant with
treatment and did not have major protocol violations. Other results from
the trial were consistent with the per-protocol population, with MOXATAG
therapy demonstrating statistical non-inferiority to the comparator therapy
in all primary and secondary endpoints.
Important Safety Information
MOXATAG is indicated for the treatment of tonsillitis and/or
pharyngitis secondary to Streptococcus pyogenes in adults and pediatric
patients 12 years or older.
MOXATAG is contraindicated in patients with known serious
hypersensitivity to amoxicillin or to other drugs in the same class or in
patients who have demonstrated anaphylactic reactions to beta-lactams.
Serious and occasionally fatal hypersensitivity (anaphylactic)
reactions have been reported in patients on penicillin therapy. These
reactions are more likely to occur in individuals with a history of
penicillin hypersensitivity and/or a history of sensitivity to multiple
allergens. Before initiating therapy with MOXATAG, careful inquiry should
be made concerning previous hypersensitivity reactions to penicillins,
cephalosporins, or other allergens. If an allergic reaction occurs, MOXATAG
should be discontinued and appropriate therapy instituted.
Clostridium difficile associated diarrhea (CDAD) has been reported with
nearly all antibacterial agents, including amoxicillin, and may range in
severity from mild diarrhea to fatal colitis. CDAD must be considered in
all patients who present with diarrhea following antibiotic use. Careful
medical history is necessary since CDAD has been reported to occur over two
months after the administration of antibacterial agents. If CDAD is
suspected or confirmed, ongoing antibiotic use not directed against C.
difficile may need to be discontinued.
In a controlled U.S. clinical trial, the majority of treatment-emergent
adverse reactions were of a mild and transient nature. The most frequently
reported adverse reactions (> 1%) which were suspected or probably drug-
related were vaginal yeast infection (2.0%), diarrhea (1.7%), nausea
(1.3%), and headache (1.0%).
Safety and effectiveness of MOXATAG in pediatric patients less than 12
years of age has not been established.
About MOXATAG(TM):
MOXATAG (amoxicillin extended-release tablets) is a once-a-day
extended- release formulation of amoxicillin for oral administration
consisting of three components: one immediate-release and two
delayed-release. The three components are combined in a specific ratio to
prolong the release of amoxicillin from MOXATAG compared to
immediate-release amoxicillin.
MOXATAG is intended to provide a lower treatment dose, once-daily
alternative to currently approved penicillin and amoxicillin regimens for
the treatment of adults and pediatric patients 12 years and older with
tonsillitis and/or pharyngitis. MiddleBrook utilized its proprietary
PULSYS(R) once-daily pulsatile delivery technology to develop MOXATAG. The
company currently has a total of 26 issued U.S. patents and two issued
foreign patents covering its PULSYS technology. Patents specifically
relating to MOXATAG run to 2020.
Amoxicillin is indicated for a broad range of infections, and is
commonly prescribed as a first-line therapy for common infections such as
otitis media (middle ear infection), pharyngitis (sore throat), and
sinusitis (sinus infection). Group A streptococcus, the primary bacteria
causing pharyngitis, have been uniformly susceptible to amoxicillin and
have not developed resistance to the penicillins, despite the long-term use
of amoxicillin for pharyngitis.
According to data from IMS Health, a pharmaceutical research company,
approximately one-quarter of amoxicillin prescriptions are written for
pharyngitis, strep throat, and tonsillitis in adults and children.
Approximately 60 million prescriptions for amoxicillin were written in 2006
with total retail sales of more than $650 million. For pediatricians,
amoxicillin is the most prescribed drug among all therapeutic classes.
Among family physicians, amoxicillin is the twelfth most prescribed drug
among all therapeutic classes.
The most commonly prescribed treatment for the management of Group A
streptococcal pharyngitis is 500 milligrams of amoxicillin dosed
three-times daily for a period of 10 days. With the FDA approval of
MOXATAG, physicians now have available the first once-daily product in the
aminopenicillin class for the treatment of pharyngitis while utilizing
approximately one-half the amount of amoxicillin currently used.
About pharyngitis/tonsillitis:
Pharyngitis is a painful inflammation of the throat caused by a variety
of microorganisms, both viral and bacterial. About 15 million patients
annually seek relief of sore throat symptoms in the United States. The most
common bacterial cause of acute pharyngitis is Streptococcus pyogenes, or
Group A streptococcus, which is referred to as "strep throat." Symptoms of
strep throat include fever, painful swallowing, swelling of the throat, and
headache. Symptomatic strep throat can lead to complications, such as
rheumatic fever, and should be treated with antibiotic therapy. Pharyngitis
ranks in the top ten diagnoses made by pediatricians, family physicians,
and emergency medicine specialists.
About Middlebrook Pharmaceuticals:
MiddleBrook Pharmaceuticals, Inc. (Nasdaq: MBRK) is a pharmaceutical
company focused on the development and commercialization of anti-infective
drug products that fulfill substantial unmet medical needs in the treatment
of infectious disease. The Company is developing anti-infective drugs based
on its novel biological finding that bacteria exposed to antibiotics in
front- loaded staccato bursts, or "pulses," are killed more efficiently and
effectively than those under standard treatment regimens. Based on this
finding, MiddleBrook has developed a proprietary, once-a-day pulsatile
delivery technology called PULSYS(TM). By applying its delivery
technologies, MiddleBrook has the potential to improve drug efficacy,
shorten length of therapy, and reduce drug resistance versus currently
available antibacterial products. For more on MiddleBrook, please visit
http://www.middlebrookpharma.com.
This announcement contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. These
statements are based on MiddleBrook's current expectations and assumptions.
These statements are not guarantees of future performance and are subject
to a number of risks and uncertainties that would cause actual results to
differ materially from those anticipated. The words, "believe," "expect,"
"intend," "anticipate," and variations of such words, and similar
expressions identify forward-looking statements, but their absence does not
mean that the statement is not forward- looking. Statements in this
announcement that are forward-looking include, but are not limited to,
statements about the Company's future development plans, clinical trials,
potential commercial success, and any financial forecasts included in this
announcement.
The actual results realized by MiddleBrook could differ materially from
these forward-looking statements, depending in particular upon the risks
and uncertainties described in the Company's filings with the Securities
and Exchange Commission. These include, without limitation, risks and
uncertainties relating to the Company's financial results and the ability
of the Company to (1) raise additional capital and continue as a going
concern, (2) increase Keflex 750 sales, (3) retain marketing approval for
its MOXATAG product, (4) successfully reduce costs, (5) reach
profitability, (6) prove that the preliminary findings for its product
candidates are valid, (7) receive required regulatory approvals, (8)
successfully conduct clinical trials in a timely manner, (9) establish its
competitive position for its products, (10) develop and commercialize
products that are superior to existing or newly developed competitor
products, (11) develop products without any defects, (12) have sufficient
capital resources to fund its operations, (13) protect its intellectual
property rights and patents, (14) implement its sales and marketing
strategy, (15) successfully attract and retain collaborative partners, (16)
successfully commercialize and gain market acceptance for its Keflex
products, (17) successfully obtain sufficient manufactured quantities of
its drug products at acceptable rates, and (18) retain its senior
management and other personnel. Existing and prospective investors are
cautioned not to place undue reliance on these forward-looking statements,
which speak only as of today's date. MiddleBrook undertakes no obligation
to update or revise the information in this announcement, whether as a
result of new information, future events or circumstances or otherwise.
MiddleBrook Pharmaceuticals, Inc.
http://www.middlebrookpharma.com
View drug information on Moxatag.
FDA a aprobat MiddleBrook de Amoxicilinã PULSYS pentru faringitã / amigdalitã la adolescenþi ºi adulþi - FDA Approves MiddleBrook's Amoxicillin PULSYS For Pharyngitis/Tonsillitis In Adolescents And Adults - articole medicale engleza - startsanatate