Pediapharm Announces the Commercial Launch of Cuvposa™ in Canada
April 03 2018 - 8:00AM
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Pediapharm Inc. (the “Company” or "Pediapharm") (TSX VENTURE:PDP)
(OTCQB:PDDPF) is very pleased to announce the Canadian commercial
launch of Cuvposa™ (Glycopyrrolate oral solution 1 mg/ 5 mL) which
is indicated to reduce chronic severe drooling in patients aged
3-18 years with neurologic conditions associated with problem
drooling (e.g. cerebral palsy (CP)).
“Cuvposa is currently being distributed within
the various wholesalers and pharmacy channels. Our sales force has
been trained and is eager to communicate with health care providers
and ultimately, help children with CP, many of whom are facing the
burden of chronic severe drooling on a daily basis.” said Richard
Labelle vice-president and marketing of Pediapharm.
Chronic drooling, or excessive production of
saliva (sialorrhea), is a common condition found in children with
CP but it may also be diagnosed in patients with other neurological
disorders (i.e. severe developmental delay, autism spectrum
disorders, sensory impairments, traumatic brain injuries as well as
neurogenetic and metabolic disorders.)
It is estimated that the cerebral palsy
prevalence ranges from 110-150 out of 100 000 people in the
population1 while prevalence of chronic drooling in children with
CP vary from 37.4% to 58%2. It has been estimated that 25% to 35%
of children with cerebral palsy drool to varying degrees, and 10%
of these children have chronic severe drooling3. The Company
estimates that in Canada, approximately 5,000 patients affected by
sialorrhea could be treated with Cuvposa.
According to Dr. Pierre Marois, Pediatric
Physiatrist at Montreal’s Ste-Justine Hospital ‘’Often
underestimated, sialorrhea implies clinical and social
consequences, and has several impacts related to the overall health
of children with CP, regarding dysphagia and respiratory health,
their socio-emotional development, and emotional and work overload
for families and caregivers’’. Furthermore, Dr. Marois added that
“due to the limited treatment options available, sialorrhea is an
all-too-often poorly managed condition in pediatric patients
suffering from neurologic disorders such as cerebral palsy. Cuvposa
is an important advancement in the treatment of chronic severe
drooling in children with neurologic disorders.’’
About Cuvposa™
Cuvposa (glycopyrrolate) is indicated to reduce
chronic severe drooling in patients aged 3 –18 years with
neurologic conditions associated with problem drooling (e.g.,
cerebral palsy). Cuvposa is available as a 1 mg/ 5 ml cherry
flavored oral solution. Glycopyrrolate is a competitive inhibitor
of acetylcholine muscarinic receptors that are located on certain
peripheral tissues, including salivary glands. Glycopyrrolate
indirectly reduces the rate of salivation by preventing the
stimulation of these receptors. Results of a randomized,
double-blind, placebo-controlled Phase 3 study of 38 patients
showed that 75% of children and adolescents treated with Cuvposa
experienced an improvement in symptoms of chronic severe drooling
at week 8, versus 11% who received placebo. Dry mouth, vomiting,
constipation, flushing and nasal congestion were the most commonly
reported adverse reactions.
About Pediapharm Inc.
Pediapharm is the only Canadian specialty
pharmaceutical company dedicated to serving the needs of the
pediatric community. Its mission is to bring to the Canadian market
the latest innovative pediatric products with the objective to
improve the health and the well-being of children in Canada. Since
its debut in 2008, Pediapharm has entered into numerous commercial
agreements with partners from Canada and other countries around the
world. The Company’s innovative product portfolio includes NYDA®, a
breakthrough treatment for head lice; Relaxa™, an osmotic laxative
used to treat constipation; EpiCeram®, a non-steroid emulsion for
eczema; naproxen suspension, indicated to treat pain and
inflammation due to various conditions, including Juvenile
Idiopathic Arthritis; Rupall™, an innovative new allergy medication
with a unique mode of action; Otixal™, the first and only
antibiotic and steroid combination ear drop available in single,
sterile, preservative-free and unit-dose packaging; and Cuvposa™,
for chronic severe drooling, a condition affecting a significant
proportion of cerebral palsy patients.
REFERENCES
- Mapping Connections: An understanding of neurological
conditions in Canada
http://www.phac-aspc.gc.ca/publicat/cd-mc/mc-ec/section-3-eng.php
- Walshe M. & al., Interventions for drooling in children
with cerebral palsy (review), The Cochrane Library 2012, Issue
11
- Drooling in children, Paediatric Child Health Vol 4 No 6
September 1999
FORWARD LOOKING STATEMENTS
This news release contains forward-looking
statements and other statements that are not historical. Such
forward-looking statements are subject to known and unknown risks,
uncertainties and assumptions that could cause actual results to
vary materially from target results and the results or events
predicted in these forward-looking statements. As a result,
investors are cautioned not to place undue reliance on these
forward-looking statements.
The forward-looking statements contained in this
news release are made as of the date of this release. Except
as required by applicable law, the Corporation disclaims any
intention and assumes no obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise. Forward-looking information
reflects the current expectations or belief of the Corporation
based on information currently available and such information is
subject to a number of assumptions, risks and uncertainties
described in details at pp. 35 to 41 of the Management Information
Circular of Chelsea Acquisition Corporation dated November 12, 2013
available on SEDAR at www.sedar.com and other risks associated with
being a specialty pharmaceutical company.
Neither TSX Venture Exchange nor its
Regulation Services Provider (as that term is defined in the
policies of the TSX Venture Exchange) accepts responsibility for
the adequacy or accuracy of this release.
PEDIAPHARM CONTACT
INFORMATION:
Sylvain Chretien, President and Chief Executive
Officer Pediapharm Inc. Tel.: 514-762-2626 ext. 201 E-mail:
sylvain.chretien@pedia-pharm.com
Roland Boivin, Chief Financial Officer
Pediapharm Inc. Tel.: 514-762-2626 ext. 202 E-mail:
roland.boivin@pedia-pharm.com
Frank CandidoDirect Financial Strategies and
Communication Inc.Tel.: 514-969-5530E-mail:
frank.candido@pedia-pharm.com
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