NASHVILLE, Tenn., Oct. 10,
2023 /PRNewswire/ -- Cumberland Pharmaceuticals
Inc. (NASDAQ: CPIX) announced today a new publication in
Antimicrobial Agents and Chemotherapy1 detailing
the results of the first clinical study investigating the safety
and pharmacokinetics of Vibativ® (telavancin)
injection in children 2 to 17 years of age. Vibativ is an
intravenous antibiotic approved by the FDA for the treatment of
hospital-acquired and ventilator-associated bacterial pneumonia
(HABP/VABP) as well as complicated skin and skin structure
infections (cSSSIs) caused by certain gram-positive bacteria in
adults2. This is the first reported study evaluating
Vibativ in pediatric patients.
"Methicillin-resistant Staphylococcus aureus (MRSA) continues to
be a problem for children. New, effective and safe therapy,
particularly once-daily therapy, will be welcomed by those who care
for children with serious MRSA infections requiring intravenous
therapy," said first author Dr. John
Bradley, Distinguished Professor of Pediatrics, University of California San Diego School of
Medicine and Medical Director of Infectious Disease at Rady
Children's Hospital of San Diego.
This publication describes results of an open-label study aimed
at characterizing a single 10 mg/kg dose of Vibativ in children 2
to 17 years of age who required systemic antibiotics for the
treatment of a known or suspected bacterial infection. Of the 22
patients treated in the study, 14 were 12 to 17 years of age, 7
were 6 to 11 years of age and one was 2 years of age. The study
found a single 10 mg/kg dose of Vibativ was safe with no serious
adverse events or renal concerns. Drug exposure to Vibativ was
lower in children compared with observations in adult
patients3.
"Antimicrobial resistance poses a significant challenge in the
treatment of bacterial infections, necessitating the development of
new antibiotic therapies. The results of this study suggest that a
single dose of Vibativ is safe in children and they experience
reduced exposure to Vibativ, compared with the same body
weight-based dosing in adults," said corresponding author Dr.
Antonio Arrieta, Professor of
Pediatrics, University of California
Irvine and Medical Director of Pediatric Infectious Disease,
Children's Hospital of Orange County.
For full prescribing and important safety information, please
see the brand's website at www.vibativ.com.
- Bradley JS, Goldman JL, James, LP, Kaelin B, Gibson BHY,
Arrieta A. Pharmacokinetics and Safety of a Single Dose of
Telavancin in Pediatric Subjects Aged 2 to 17 Years of Age.
Antimicrob Agents Chemother. October
10, 2023.
- Vibativ® (telavancin) [Package Insert]. Cumberland
Pharmaceuticals Inc. Nashville,
TN; 2020.
- Worboys PD, Wong SL, Barriere SL. Pharmacokinetics of
intravenous telavancin in healthy subjects with varying degrees of
renal impairment. Eur J Clin Pharmacol. 2015 Jun 1;71(6):707–14.
About Vibativ® (telavancin) for Injection
Vibativ is a patented, FDA-approved injectable anti-infective
for the treatment of certain serious bacterial infections including
hospital-acquired and ventilator-associated bacterial pneumonia and
complicated skin and skin structure infections. It addresses a
range of Gram-positive bacterial pathogens, including those that
are considered difficult-to-treat and multidrug-resistant.
Intravenous unfractionated heparin sodium is contraindicated with
Vibativ administration due to artificially prolonged activated
partial thromboplastin time (aPTT) test results for up to 18 hours
after Vibativ administration. Vibativ is contraindicated in
patients with a known hypersensitivity to telavancin. For more
information please visit www.vibativ.com.
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical
company focused on the delivery of high-quality prescription brands
to improve patient care. The company develops, acquires, and
commercializes brands for the hospital acute care, gastroenterology
and rheumatology market segments. The company's portfolio of
FDA-approved brands includes:
- Acetadote® (acetylcysteine) injection,
for the treatment of acetaminophen poisoning;
- Caldolor® (ibuprofen) injection,
for the treatment of pain and fever;
- Kristalose® (lactulose) for oral
solution, a prescription laxative, for the treatment of
constipation;
- Omeclamox®-Pak, (omeprazole,
clarithromycin, amoxicillin) for the treatment of Helicobacter
pylori (H. pylori) infection and related duodenal ulcer
disease;
- Sancuso® (granisetron)
transdermal system, for the prevention of nausea and vomiting in
patients receiving certain types of chemotherapy treatment;
- Vaprisol® (conivaptan) injection,
to raise serum sodium levels in hospitalized patients with
euvolemic and hypervolemic hyponatremia; and
- Vibativ® (telavancin) injection,
for the treatment of certain serious bacterial infections including
hospital-acquired and ventilator-associated bacterial pneumonia, as
well as complicated skin and skin structure infections.
The company also has a series of Phase II clinical programs
underway evaluating its ifetroban product candidates in patients
with cardiomyopathy associated with Duchenne Muscular Dystrophy
("DMD") and Systemic Sclerosis ("SSc").
For more information on Cumberland's approved products, including full
prescribing information, please visit the individual product
websites, links to which can be found on the company's website
www.cumberlandpharma.com.
Forward-looking Statements:
This press release contains forward-looking statements, which
are subject to certain risks and reflect Cumberland's current views on future events
based on what it believes are reasonable assumptions. No assurance
can be given that these events will occur. Forward-looking
statements include, among other things, statements regarding the
company's intent, belief or expectations, and can be identified by
the use of terminology such as "may," "will," "expect," "believe,"
"intend," "plan," "estimate," "should," "seek," "anticipate" and
other comparable terms or the negative thereof. As with any
business, all phases of Cumberland's operations are subject to factors
outside of its control, and any one or combination of these factors
could materially affect Cumberland's operation results. These factors
include market conditions, competition, an inability of
manufacturers to produce Cumberland's products on a timely basis,
failure of manufacturers to comply with regulations applicable to
pharmaceutical manufacturers, natural disasters, public health
epidemics, maintaining an effective sales and marketing
infrastructure, and other events beyond the company's control as
more fully discussed in its most recent 10-Q as filed with the SEC.
There can be no assurance that results anticipated by the company
will be realized or that they will have the expected effects.
Readers are cautioned not to place undue reliance on
forward-looking statements, which speak only as of the date hereof.
The company does not undertake any obligation to publicly revise
these statements to reflect events after the date hereof.
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