BERWYN, Pa., Oct. 11, 2016
/PRNewswire/ -- Vernalis Therapeutics, Inc. today announced that it
has begun promoting MOXATAG® (amoxicillin
extended-release) Tablets to primary care physicians in the U.S.
MOXATAG is the first and only approved once-daily formulation of
the widely-used antibiotic amoxicillin. Parent company, Vernalis
plc (LSE: VER), acquired the U.S. rights to MOXATAG from Pragma
Pharmaceuticals, LLC in 2015.
Approved by the FDA in 2008, MOXATAG is a penicillin-class
antibacterial indicated for the treatment of tonsillitis and/or
pharyngitis secondary to Streptococcus pyogenes (S.
pyogenes) in adults and pediatric patients 12 years of age or
older.
"We are excited to be promoting MOXATAG, the only once-daily
formulation of the well-known antibiotic amoxicillin to physicians
in the U.S. The benefit of taking one pill per day versus
multiple times a day may represent an improvement in convenience
for patients," said Sandy Sommer,
President and Chief Operating Officer, Vernalis Therapeutics, Inc.
"MOXATAG is a natural complement to our 12-hour codeine based
prescription medication, TUZISTRA® XR, as both products
offer physicians and patients an extended-release alternative to
existing treatments."
Product Information
The NDC number for
Vernalis-labeled MOXATAG (amoxicillin extended-release) Tablets in
30-count bottles is 69442-0030-01. The NDC number for 10-count
bottles is 69442-0030-10. For questions about ordering MOXATAG,
please call Vernalis at 1-88VERNALIS (1-888-376-2547).
The U.S. Antibiotic Market
According to IMS Health,
(MAT February 2015 data) 14 million
patients diagnosed with tonsillitis and/or pharyngitis secondary to
S. pyogenes were treated with antibiotics, and of these
patients, three million people 12 years of age and older were
treated with amoxicillin. The target market is estimated to be
between two and three million prescriptions annually for patients
12 years of age or older that are treated by primary care
physicians.
Indication
MOXATAG (amoxicillin extended-release) is a penicillin-class
antibacterial indicated for the treatment of tonsillitis and/or
pharyngitis secondary to Streptococcus pyogenes (S.
pyogenes) in adults and pediatric patients 12 years and
older.
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of MOXATAG and other antibacterial
drugs, MOXATAG should be used only to treat or prevent infections
that are proven or strongly suspected to be caused by bacteria.
Dosage and Administration
The recommended dose of MOXATAG for tonsillitis and/or
pharyngitis is 775 mg once daily taken within 1 hour of finishing a
meal for 10 days. The full 10-day course of therapy should be
completed for effective treatment of tonsillitis and/or pharyngitis
secondary to S. pyogenes. Do not chew or crush
tablet.
The technology behind once-daily dosing
Through its delivery system, MOXATAG releases medicine in 3
separate pulses over time in different parts of the intestinal
tract. This timed release of medicine throughout the day ensures
that there is enough amoxicillin in your system to treat your
infection with 1 dose each day for 10 days.
IMPORTANT SAFETY INFORMATION:
- Contraindications: Patients with known serious hypersensitivity
to amoxicillin or to other drugs in the same class or patients who
have demonstrated anaphylactic reactions to beta-lactams
- Serious and occasionally fatal hypersensitivity (anaphylactic)
reactions have been reported in patients on penicillin therapy and
are more likely to occur in individuals with a history of
penicillin hypersensitivity and/or a history of sensitivity to
multiple allergens, so careful inquiry about a history of
hypersensitivity reactions to penicillins, cephalosporins or other
allergens should be made. Serious anaphylactic reactions require
immediate emergency treatment with epinephrine. Oxygen, intravenous
steroids, and airway management, including intubation, should also
be administered as indicated.
- Clostridium difficile associated diarrhea (ranging from
mild diarrhea to fatal colitis) has been reported with nearly all
antibacterial agents, including amoxicillin. Evaluate if diarrhea
occurs.
- The possibility of superinfections with mycotic or bacterial
pathogens should be kept in mind during therapy. If superinfections
occur, amoxicillin should be discontinued and appropriate therapy
instituted.
- Mononucleosis rash: Ampicillin-class antibiotics should not be
administered to patients with mononucleosis because a high
percentage develops a rash.
- Risk of development of drug-resistant bacteria is increased by
prescribing amoxicillin in the absence of proven or strongly
suspected bacterial infection or treating prophylactically and is
unlikely to provide benefit to the patient.
- False-positive urinary glucose tests may occur with
amoxicillin. Glucose tests based on enzymatic glucose oxidase
reactions (such as Clinistixâ) are recommended.
- The most common drug-related adverse reactions (incidence ≥1.0
%) are vulvovaginal mycotic infection, diarrhea, nausea, vomiting
and headache.
To report SUSPECTED ADVERSE
REACTIONS, contact Vernalis Therapeutics, Inc. at 1-855-705-9546
and www.vernalistherapeutics.com or FDA at
1-800 -FDA-1088 or www.fda.gov/medwatch.
- Probenecid decreases the renal tubular secretion of
amoxicillin. Concurrent use of amoxicillin and probenecid may
result in increased and prolonged blood levels of amoxicillin.
- Reduced efficacy of combined oral estrogen/progesterone
contraceptives may result from use of amoxicillin or other
antibiotics.
- Pediatrics: The safety and effectiveness of MOXATAG in
pediatric patients younger than 12 years has not been
established.
- Renal Impairment: MOXATAG has not been studied in patients with
renal impairment; however a reduction of amoxicillin dose is
generally recommended for patients with severe renal impairment.
Therefore, MOXATAG is not recommended for use in patients with
severe renal impairment (CrCl < 30 mL/min) or patients on
hemodialysis.
Click here for full Prescribing Information
TUZISTRA® XR (codeine polistirex and
chlorpheniramine polistirex) extended-release oral suspension,
CIII
WARNING: DEATH
RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO
MORPHINE
Respiratory
depression and death have occurred in children who received codeine
following tonsillectomy and/or adenoidectomy and had evidence of
being ultra-rapid metabolizers of codeine due to a CYP2D6
polymorphism
|
INDICATIONS AND USAGE
TUZISTRA XR is a combination of codeine, an opiate agonist
antitussive, and chlorpheniramine, a histamine-1 (H1)
receptor antagonist indicated for relief of cough and symptoms
associated with upper respiratory allergies or a common cold.
Limitation of Use: Not indicated for pediatric patients under 18
years of age.
IMPORTANT SAFETY INFORMATION
- CONTRAINDICATIONS
- Postoperative pain management of children undergoing
tonsillectomy and/or adenoidectomy.
- Patients with known hypersensitivity to codeine,
chlorpheniramine, or any of the product components of TUZISTRA
XR.
- WARNINGS AND PRECAUTIONS
- Risk of death in ultra-rapid metabolizers: Conversion of
codeine into its active metabolite, morphine, may occur more
rapidly and completely resulting in higher than expected morphine
levels and respiratory depression or death. Some individuals may be
ultra-rapid metabolizers because of a specific CYP2D6 genotype,
which prevalence varies widely, and is estimated at 0.5 to 1% in
Chinese and Japanese, 0.5 to 1% in Hispanics, 1 to 10% in
Caucasians, 3% in African Americans, and 16 to 28% in North
Africans, Ethiopians, and Arabs.
- Dose-related respiratory depression: Use with caution,
including when used postoperatively, in patients with pulmonary
disease or shortness of breath, or whenever ventilator function is
depressed. Overdose of codeine in adults has been associated
with fatal respiratory depression, and the use of codeine in
children has been associated with fatal respiratory
depression. If respiratory depression occurs, discontinue the
drug and use naloxone or other supportive measures as
necessary.
- Drug dependence: Prescribe with caution that is appropriate to
the use of other opioids.
- Head injury and increased intracranial pressure: Avoid in
patients with head injury, intra-cranial lesions, or increased
intracranial pressure.
- Activities requiring mental alertness: Avoid engaging in
hazardous tasks requiring complete mental alertness such as driving
or operating heavy machinery. Avoid concurrent use of alcohol or
other central nervous system depressants.
- Obstructive Bowel Disease Caution: Chronic use may result in
constipation or chronic obstructive bowel disease, especially in
patients with underlying intestinal motility disorders.
- Acute abdominal conditions: Use with caution in patients with
acute abdominal conditions.
- Dosing Caution: Measure dose with an accurate milliliter
measuring device; a household teaspoon is not accurate and could
lead to overdosage, resulting in serious adverse reactions.
- Special risk patients: Caution in elderly patients and those
with asthma, hypothyroidism, Addison's disease, prostatic
hypertrophy or urethral stricture.
- ADVERSE REACTIONS:
- Common adverse reactions of TUZISTRA XR include: nausea and
vomiting, constipation, abdominal distension, abdominal pain,
blurred vision, diplopia, visual disturbances, confusion,
dizziness, depression, drowsiness, sedation, headache, euphoria,
facial dyskinesia, feeling faint, light-headedness, general feeling
of discomfort or illness, excitability, nervousness, agitation,
restlessness, somnolence, insomnia, dyskinesia, irritability,
tremor.
To report SUSPECTED ADVERSE REACTIONS, contact Vernalis Therapeutics, Inc. at 1-855-705-9546 and www.vernalistherapeutics.com
or FDA at 1-800 -FDA-1088 or
www.fda.gov/medwatch.
Click here for full Prescribing Information
About Vernalis Therapeutics, Inc.
Vernalis
Therapeutics, Inc., commercializes prescription pharmaceutical
products in the U.S. on behalf of its parent organization, Vernalis
plc (LSE: VER). The Company is currently focused on marketing and
distributing prescription products that are uniquely engineered to
relieve respiratory symptoms for extended periods of time. In
addition to MOXATAG and TUZISTRA XR, the Company has four
extended-release cough cold products in active development.
For more information, visit www.vernalistherapeutics.com.
Vernalis Forward-Looking Statement
This news release
may contain forward-looking statements that reflect the Company's
current expectations regarding future events including the clinical
development and regulatory clearance of the Company's products, the
Company's ability to find partners for the development and
commercialization of its products, as well as the Company's future
capital raising activities. Forward-looking statements involve
risks and uncertainties. Actual events could differ materially from
those projected herein and depend on a number of factors including
the success of the Company's research strategies, the applicability
of the discoveries made therein, the successful and timely
completion of clinical studies, the uncertainties related to the
regulatory process, the ability of the Company to identify and
agree to beneficial terms with suitable partners for the
commercialization and/or development of its products, as well as
the achievement of expected synergies from such transactions, the
acceptance of TUZISTRA XR, MOXATAG, frovatriptan and other products
by consumers and medical professionals, the successful integration
of completed mergers and acquisitions and achievement of expected
synergies from such transactions, and the ability of the Company to
identify and consummate suitable strategic and business combination
transactions.
© 2016 Vernalis Therapeutics, Inc. All rights reserved.
MOXATAG and TUZISTRA are licensed trademarks of Vernalis
Therapeutics, Inc.
VTI-0024 09/2016
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SOURCE Vernalis Therapeutics, Inc.