MiddleBrook Pharmaceuticals Launches MOXATAG™, the First and Only FDA-Approved Once-Daily Amoxicillin
16 Marzo 2009 - 2:15PM
Business Wire
MiddleBrook Pharmaceuticals, Inc. (Nasdaq: MBRK) today launched
MOXATAG (extended-release amoxicillin) Tablets, 775 mg, the first
and only FDA-approved once-daily amoxicillin. MOXATAG is approved
for the treatment of pharyngitis/tonsillitis secondary to
Streptococcus pyogenes in patients twelve years and older. MOXATAG
is dosed once-daily at 775 mg, versus the current most commonly
prescribed generic amoxicillin treatment regimen for
pharyngitis/tonsillitis which is 500 mg three times per day
according to the 2008 IMS Health National Drug Therapeutic Index.
There is no AB-rated generic for MOXATAG.
MOXATAG is the first product formulated with MiddleBrook�s
proprietary PULSYS� technology. PULSYS enables the pulsatile
delivery, or delivery in rapid bursts, of amoxicillin from MOXATAG.
MiddleBrook�s PULSYS technology prolongs the release and absorption
of amoxicillin from MOXATAG.
�MOXATAG�s once-daily dosing advances traditional treatment with
amoxicillin, a drug that has been trusted and relied upon for the
treatment of pharyngitis and tonsillitis for decades,� said
MiddleBrook President & CEO John Thievon. �MOXATAG is
effective, and MOXATAG uses a lower overall dose than conventional
amoxicillin or penicillin treatments for pharyngitis and
tonsillitis.�
�Studies show that enhanced patient convenience improves
compliance,� Thievon continued, �and we believe that compliance is
a critical success factor in antibiotic therapy. In fact, studies
show that failure to take antibiotics properly is the number one
reason patients fail antibiotic therapy. Accordingly, MOXATAG has
the potential to help improve clinical outcomes. Our 271-person
field force today began educating healthcare professionals across
the nation about the benefits of MOXATAG. We are excited about
MOXATAG�s commercial potential.�
About MiddleBrook
Pharmaceuticals:
MiddleBrook Pharmaceuticals, Inc. (Nasdaq: MBRK) is a
pharmaceutical company focused on developing and commercializing
anti-infective products that fulfill unmet medical needs. We have
developed a proprietary delivery technology called PULSYS, which
enables the pulsatile delivery, or delivery in rapid bursts, of
certain drugs. We are currently developing a portfolio of
anti-infective PULSYS products. Our near-term corporate strategy is
to improve dosing regimens and/or reduce frequency of dosing which
we believe will result in improved patient dosing convenience and
compliance for antibiotics that have been used and trusted by
physicians and patients for decades. MiddleBrook currently markets
KEFLEX, the immediate-release brand of cephalexin, and MOXATAG �
the first and only FDA-approved once-daily amoxicillin. For more
information about MiddleBrook, please visit
www.middlebrookpharma.com.
About MOXATAG:
MOXATAG (amoxicillin extended-release) Tablets, 775mg, is a
once-a-day extended-release formulation of amoxicillin for oral
administration consisting of three components: one
immediate-release component and two delayed-release components. The
three components of MOXATAG are combined in a specific ratio to
prolong the release of amoxicillin 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.
For more information about MOXATAG, please visit
www.middlebrookpharma.com.
Forward-Looking
Statements:
This announcement contains forward-looking statements, within
the meaning of Section 21E of the Securities Exchange Act of 1934
and Section 27A of the Securities Act of 1933, that involve risks
and uncertainties. In some cases, forward-looking statements are
identified by words such as "believe," "anticipate," "expect,"
"intend," "plan," "potential," "estimate," "will," "may,"
"predict," "should," "could," "would" and similar expressions. You
should not place undue reliance on these forward-looking
statements, which speak only as of the date of this announcement.
All of these forward-looking statements are based on information
available to us at this time. Actual results could differ from
those projected in these forward-looking statements as a result of
many factors, including those identified in the sections titled
"Risk Factors" and "Management's Discussion and Analysis of
Financial Condition and Results of Operations," and elsewhere in
our Annual Report on Form 10-K for the year ended Dec. 31, 2008,
and in similar disclosures made by us from time to time in our
other filings with the Securities and Exchange Commission. We
undertake no obligation to update forward-looking statements,
whether as a result of new information, future events or otherwise.
You are advised, however, to consult any further disclosures we
make on related subjects in our filings with the Securities and
Exchange Commission. KEFLEX, MiddleBrook, MiddleBrook
Pharmaceuticals (stylized), MiddleBrook Pharmaceuticals, Inc., M1
(stylized), MOX-10, MOXAKIT, MOXATAG1 (stylized), MOXATAG, MOXATEN,
MOX-PAK and PULSYS are our trademarks and have been registered in
the U.S. Patent and trademark office or are the subject of pending
U.S. trademarks applications. Each of the other trademarks,
tradenames, or service marks appearing in this document belongs to
the respective holder. As used herein, except as otherwise
indicated by the context, references to �we,� �us,� �our,�
�MiddleBrook,� or the �Company,� refer to MiddleBrook
Pharmaceuticals, Inc., and its subsidiaries.
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