- NDS Included 48 Clinical Studies Involving More Than 2,900 Subjects
Treated With Lurasidone
MISSISSAUGA, ON, June 15, 2012 /CNW/ - Sunovion Pharmaceuticals Canada
Inc. today announced that the New Drug Submission (NDS) for LATUDA™
(lurasidone HCl), for the treatment of adult patients with acute
schizophrenia has been approved by Health Canada. "We are pleased that
LATUDA has achieved this significant milestone," said Douglas Reynolds,
President, Sunovion Pharmaceuticals Canada Inc. "More importantly,
LATUDA will provide patients in Canada suffering from schizophrenia a
new option that can help support their treatment goals for this serious
and complex disorder."
"Schizophrenia is a disease that is complex and a challenge to treat
effectively," said Dr. Philip Tibbo, Psychiatrist at Capital District
Health Authority and Director of the Nova Scotia Early Psychosis
Program in Halifax. "Each person suffering from schizophrenia is
different, and new treatment options are always needed. Effective,
individualized treatment that offers a balance between efficacy, safety
and tolerability can help support each patient to reach their treatment
"It is important to always have a number of treatment options available
for those living with schizophrenia." said Chris Summerville, Chief
Executive Officer of the Schizophrenia Society of Canada.
"Schizophrenia is treatable, and individual patient recovery is
possible. More choice in finding the right medication is vital, and
having more treatment options accessible to patients by all private and
public drug plans in Canada can help greatly in supporting their
Schizophrenia is a chronic, disabling disorder that is characterized by
symptoms such as hallucinations, delusions, disorganized thinking, lack
of emotion, lack of energy, as well as problems with memory, attention
and the ability to plan, organize and make decisions. This disease
affects approximately one percent of the population, which translates
to more than 335,000 Canadians. The goal of treatment is to reduce
symptoms, achieve remission, and facilitate illness recovery. While
there are many treatment options available, each patient responds to
their medications differently. A key obstacle is the ability to
tolerate medications and unfortunately treatment discontinuation in
this disease is as high as 40-50%2. Discontinuation is only partly due to intolerability; lack of efficacy
plays the biggest role. Effective treatment for each patient requires
the right balance of efficacy, safety and tolerability.
LATUDA (lurasidone HCl) is a new medication in the atypical
antipsychotic class that has been approved by Health Canada for the
acute treatment of adult patients with schizophrenia.
LATUDA has been extensively studied through 48 clinical studies
involving more than 2,900 lurasidone-treated subjects. The efficacy of
LATUDA was demonstrated in five six-week, placebo-controlled studies,
involving hospitalized patients with schizophrenia. The efficacy of
LATUDA for long-term use, that is, for more than 6 weeks, has not been
systemically evaluated in controlled studies. LATUDA was associated
with low rates of change in metabolic parameters versus placebo.
Further, the pharmacokinetic properties provide once-daily dosing. The
most common adverse events in patients treated with LATUDA are
somnolence, akathisia, nausea, and parkinsonism.
About Sunovion Pharmaceuticals Canada Inc.
Sunovion Pharmaceuticals Canada Inc. is focused on the development and
commercialization of prescription products in Canada. In addition to
commercializing Sunovion Pharmaceuticals Inc.'s products, our strategy
is to license pharmaceutical products that meet the needs of patients
and the Canadian health care system, currently focusing on
cardiovascular disease, infectious disease and central nervous system
(CNS) disorders. More information about Sunovion Pharmaceuticals
Canada Inc. is available at www.sunovion.ca
Sunovion Pharmaceuticals Canada Inc., a subsidiary of the U.S. based
Sunovion Pharmaceuticals Inc., is headquartered in Mississauga,
Ontario. Sunovion Pharmaceuticals Inc., an indirect, wholly-owned
subsidiary of Dainippon Sumitomo Pharma Co., Ltd., is headquartered in
Marlborough, Mass. More information about Sunovion Pharmaceuticals
Inc. is available at www.sunovion.com.
About Dainippon Sumitomo Pharma Co., Ltd. (DSP)
DSP is a multi-billion dollar, top-ten listed pharmaceutical company in
Japan with a diverse portfolio of pharmaceutical, animal health and
food and specialty products. DSP aims to produce innovative
pharmaceutical products in the CNS field, which has been designated as
the key therapeutic area and will also focus in on other specialty
disease categories with significant unmet medical needs, which are
designated as frontier therapeutic areas. DSP is based on the merger in
2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo
Pharmaceuticals Co., Ltd. Today, DSP has more than 7,000 employees
worldwide. Additional information about DSP is available through its
corporate website at www.ds-pharma.com.
LATUDATM is a registered trademark of Dainippon Sumitomo Pharma Co., Ltd.
1 Public Health Agency of Canada, Available at: http://www.phac-aspc.gc.ca/publicat/miic-mmac/chap_3-eng.php. Accessed June 11, 2012.
2 IMS Brogan, March 2012
For a copy of this release or any recent release,
visit Sunovion's web site at www.sunovion.ca
SOURCE Sunovion Pharmaceuticals Canada Inc.
For further information:
Sunovion Pharmaceuticals Canada Inc.
Vice President, Corporate Communications
Sunovion Pharmaceuticals Inc.