Sunovion Pharmaceuticals Inc. Presents Data Showing 12 Months of Latuda® (lurasidone HCl) Treatment Resulted in Higher

  Sunovion Pharmaceuticals Inc. Presents Data Showing 12 Months of Latuda®
  (lurasidone HCl) Treatment Resulted in Higher Remission Rates in Adult
  Patients with Schizophrenia Compared to Seroquel XR® (quetiapine XR)

Presented at the 166^th American Psychiatric Association Annual Meeting in San

Business Wire

MARLBOROUGH, Mass. -- May 21, 2013

Sunovion Pharmaceuticals Inc. today announced results from a post-hoc study
analysis showing that adult patients with schizophrenia who were treated with
Latuda^® (lurasidone HCl) were more likely to achieve sustained remission over
12 months of treatment compared to patients taking Seroquel XR^® (quetiapine
XR). The analysis utilized remission criteria that were established by the
Research in Schizophrenia Working Group in 2005.^1 In addition, over the
12-month study period, patients treated with quetiapine XR discontinued at a
greater rate than patients treated with LATUDA.

“Achieving remission is a key goal for clinicians treating patients with
schizophrenia. Patients who achieve remission tend to have improved functional
and occupational outcomes, as well as lower risk of relapse,” said Antony
Loebel, M.D., Executive Vice President and Chief Medical Officer of Sunovion
Pharmaceuticals Inc. “These findings suggest that remission is an attainable
goal in the treatment of patients with schizophrenia.”

The objective of this post-hoc analysis was to evaluate the frequency of
sustained remission in patients treated for up to 12 months in a double-blind
study. All patients had initially been hospitalized with an acute exacerbation
of schizophrenia and completed a six-week, placebo-controlled, acute phase
study.^i Eligible patients were then continued in a 12-month, double-blind,
parallel-group study involving flexibly dosed LATUDA (40-160 mg/day) or
quetiapine XR (200-800 mg/day). The primary efficacy endpoint of this study
was time to first relapse of psychotic symptoms, applying pre-specified
relapse criteria, in a non-inferiority analysis using a Cox proportional
hazards regression model.

Key findings from this 12-month, double-blind, non-inferiority study (Loebel
et al. Schizophrenia Research 2013;147:95-102) and post-hoc analysis were as

  *Risk of relapse: In this study, LATUDA was found to be non-inferior to
    quetiapine XR for time to relapse. LATUDA was associated with a 27.2%
    reduction in relative relapse risk vs. quetiapine XR, indicated by a
    hazard ratio of 0.728 (95% confidence interval: 0.410, 1.295).
  *Sustained remission^ii: Patients treated with LATUDA were significantly
    more likely than patients treated with quetiapine XR to meet sustained
    remission criteria at Month 12 (61.9% vs. 46.3%; p<0.05; LOCF).
  *Symptomatic remission^iii: Patients treated with LATUDA were significantly
    more likely than patients treated with quetiapine XR to achieve
    symptomatic remission at Month 6 (66.7% vs. 52.7%; p<0.01); numerical
    separation in symptomatic remission rates was maintained at Month 12
    (75.3% vs. 68.6%).
  *Discontinuation rates: Overall discontinuation rates over the 12-month
    study period were 48.3% for LATUDA and 61.2% for quetiapine XR.

^i[A total of 488 patients who participated in a six-week, double-blind,
placebo-controlled study were randomized to treatment with one of the
following: LATUDA 80 mg/day, LATUDA 160 mg/day, quetiapine XR 600 mg/day or
placebo. A total of 292 patients entered the 12-month follow-on study (Loebel
et al. Schizophrenia Research 2013;145:101-9).]

^ii [Sustained remission was defined based on Remission in Schizophrenia
Working Group criteria (RSWG; Andreasen NC et al, Am J Psychiatry
2005;162:441-9), which requires that patients be assessed as mild or better in
eight specific items of the PANSS over an at least six-month period.]

^ii [ Symptomatic remission was defined as meeting the PANSS item criteria
only at the time of evaluation.]

About Schizophrenia

Schizophrenia is a chronic, serious and often severely disabling brain
disorder that affects approximately 1 in 100 American adults (about 2.4
million people).^2 Schizophrenia is characterized by symptoms such as
hallucinations, delusions, disorganized thinking, lack of emotion and lack of
energy, as well as problems with memory, attention and the ability to plan,
organize and make decisions.^3


LATUDA is an atypical antipsychotic agent indicated for the treatment of
patients with schizophrenia. Efficacy was established in five six-week
controlled studies of adult patients with schizophrenia. The effectiveness of
LATUDA for longer-term use, that is, for more than six weeks, has not been
established in controlled studies. Therefore, the physician who elects to use
LATUDA for extended periods should periodically re-evaluate the long-term
usefulness of the drug for the individual patient.

The recommended starting dose for LATUDA for the treatment of patients with
schizophrenia is 40 mg once daily taken with food (at least 350 calories) with
no initial dose titration required. LATUDA has been shown to be effective in a
dose range of 40 mg/day to 160 mg/day. The maximum recommended dose is 160
mg/day. For patients with moderate and severe renal or hepatic impairment, the
recommended starting dose of LATUDA is 20 mg/day. The maximum recommended dose
is 80 mg/day in patients with moderate hepatic impairment and 40 mg/day in
patients with severe hepatic impairment. The recommended starting dose of
LATUDA in patients taking a moderate CYP3A4 inhibitor such as diltiazem is 20
mg/day with a maximum recommended dose of 80 mg/day. LATUDA should not be
administered with strong CYP3A4 inhibitors such as ketoconazole or strong
CYP3A4 inducers such as rifampin.

Please see Important Safety Information, including Boxed Warning below, and
full Prescribing Information at

LATUDA received FDA approval for the treatment of adult patients with
schizophrenia on October 28, 2010 and is available in the U.S. and Canada. On
October 30, 2012, the FDA accepted two supplemental New Drug Applications
(sNDAs) for the use of LATUDA as monotherapy and adjunctive therapy to lithium
or valproate, both to treat adult patients with depressive episodes associated
with bipolar I disorder (bipolar depression).



         See full prescribing information for complete boxed warning.

  *Elderly patients with dementia-related psychosis treated with
    antipsychotic drugs are at an increased risk of death.
  *LATUDA is not approved for the treatment of patients with dementia-related


LATUDA is contraindicated in the following:

  *Any patient with a known hypersensitivity to lurasidone HCl or any
    components in the formulation. Angioedema has been observed with
  *Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole).
  *Concomitant use with strong CYP3A4 inducers (e.g., rifampin).


Cerebrovascular Adverse Reactions, Including Stroke: In placebo-controlled
trials with risperidone, aripiprazole, and olanzapine in elderly subjects with
dementia, there was a higher incidence of cerebrovascular adverse reactions
(cerebrovascular accidents and transient ischemic attacks) including
fatalities compared to placebo-treated subjects. LATUDA is not approved for
the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom
complex, has been reported with administration of antipsychotic drugs,
including LATUDA. NMS can cause hyperpyrexia, muscle rigidity, altered mental
status and evidence of autonomic instability (irregular pulse or blood
pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs
may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis),
and acute renal failure. The management of NMS should include: 1) immediate
discontinuation of antipsychotic drugs and other drugs not essential to
concurrent therapy; 2) intensive symptomatic treatment and medical monitoring;
and 3) treatment of any concomitant serious medical problems for which
specific treatments are available.

Tardive Dyskinesia (TD): TD is a syndrome consisting of potentially
irreversible, involuntary, dyskinetic movements that can develop in patients
with antipsychotic drugs. There is no known treatment for established cases of
TD, although the syndrome may remit, partially or completely, if antipsychotic
treatment is withdrawn. The risk of developing TD and the likelihood that it
will become irreversible are believed to increase as the duration of treatment
and the total cumulative dose of antipsychotic drugs administered to the
patient increase. However, the syndrome can develop, although much less
commonly, after relatively brief treatment periods at low doses. Given these
considerations, LATUDA should be prescribed in a manner that is most likely to
minimize the occurrence of TD. If signs and symptoms appear in a patient on
LATUDA, drug discontinuation should be considered.

Metabolic Changes

Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases extreme and
associated with ketoacidosis or hyperosmolar coma or death, has been reported
in patients treated with atypical antipsychotics. Patients with risk factors
for diabetes mellitus (e.g., obesity, family history of diabetes) who are
starting treatment with atypical antipsychotics should undergo fasting blood
glucose testing at the beginning of and periodically during treatment. Any
patient treated with atypical antipsychotics should be monitored for symptoms
of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness.
Patients who develop symptoms of hyperglycemia during treatment with atypical
antipsychotics should undergo fasting blood glucose testing. In some cases,
hyperglycemia has resolved when the atypical antipsychotic was discontinued;
however, some patients required continuation of anti-diabetic treatment
despite discontinuation of the suspect drug.

Dyslipidemia:  Undesirable alterations in lipids have been observed in
patients treated with atypical antipsychotics.

Weight Gain: Weight gain has been observed with atypical antipsychotic use.
Clinical monitoring of weight is recommended.

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors,
LATUDA elevates prolactin levels. Galactorrhea, amenorrhea, gynecomastia, and
impotence have been reported in patients receiving prolactin-elevating
compounds. In short-term, placebo-controlled studies, the median change from
baseline to endpoint in prolactin levels for LATUDA-treated females was -0.2
ng/mL and was 0.5 ng/mL for males. The proportion of female patients with
prolactin elevations ≥5x ULN was 5.7% for LATUDA-treated patients versus 2.0%
for placebo-treated female patients. The proportion of male patients with
prolactin elevations > 5x ULN was 1.6% versus 0.6% for placebo-treated male

Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia/neutropenia has been
reported during treatment with antipsychotic agents. Agranulocytosis
(including fatal cases) has been reported with other agents in the class.
Patients with a preexisting low white blood cell count (WBC) or a history of
drug induced leukopenia/neutropenia should have their complete blood count
(CBC) monitored frequently during the first few months of therapy, and LATUDA
should be discontinued at the first sign of a decline in WBC in the absence of
other causative factors.

Orthostatic Hypotension and Syncope: LATUDA may cause orthostatic hypotension.
Orthostatic vital signs should be monitored in patients who are vulnerable to
hypotension and in patients with known cardiovascular disease or
cerebrovascular disease.

Seizures: LATUDA should be used cautiously in patients with a history of
seizures or with conditions that lower seizure threshold (e.g., Alzheimer’s

Potential for Cognitive and Motor Impairment: In short-term,
placebo-controlled trials, somnolence was reported in 17.0% (256/1508) of
patients treated with LATUDA compared to 7.1% (50/708) of placebo patients,
respectively. Patients should be cautioned about operating hazardous
machinery, including motor vehicles, until they are reasonably certain that
therapy with LATUDA does not affect them adversely.

Body Temperature Regulation: Disruption of the body’s ability to reduce core
body temperature has been attributed to antipsychotic agents. Appropriate care
is advised when prescribing LATUDA for patients who will be experiencing
conditions that may contribute to an elevation in core body temperature, e.g.,
exercising strenuously, exposure to extreme heat, receiving concomitant
medication with anticholinergic activity, or being subject to dehydration.

Suicide: The possibility of suicide attempt is inherent in psychotic illness
and close supervision of high-risk patients should accompany drug therapy.
Prescriptions for LATUDA should be written for the smallest quantity of
tablets consistent with good patient management in order to reduce the risk of

Dysphagia: Esophageal dysmotility and aspiration have been associated with
antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity
and mortality in elderly patients, in particular those with advanced
Alzheimer’s dementia. LATUDA and other antipsychotic drugs should be used
cautiously in patients at risk for aspiration pneumonia.


Commonly Observed Adverse Reactions: (incidence ≥ 5% and at least twice the
rate of placebo) in patients treated with LATUDA were somnolence, akathisia,
nausea and parkinsonism.

Before prescribing LATUDA, please read the full Prescribing Information,
including Boxed Warning at

About Sunovion Pharmaceuticals Inc. (Sunovion)

Sunovion is a leading pharmaceutical company dedicated to discovering,
developing and commercializing therapeutic products that advance the science
of medicine in the Psychiatry, Neurology and Respiratory disease areas and
improve the lives of patients and their families. Sunovion's drug development
program, together with its corporate development and licensing efforts, has
yielded a portfolio of pharmaceutical products including LATUDA^® (lurasidone
HCl) tablets, LUNESTA^® (eszopiclone) tablets, XOPENEX^® (levalbuterol HCI)
inhalation solution, XOPENEX HFA^® (levalbuterol tartrate) inhalation aerosol,
BROVANA^® (arformoterol tartrate) inhalation solution, OMNARIS^® (ciclesonide)
nasal spray, ZETONNA^® (ciclesonide) nasal aerosol and ALVESCO^® (ciclesonide)
inhalation aerosol.

Sunovion, 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

About Dainippon Sumitomo Pharma Co., Ltd. (DSP)

Dainippon Sumitomo Pharma Co., Ltd. (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 Psychiatry & Neurology
field, which has been designated as one of the two key 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

LATUDA ^ is a registered trademark of Dainippon Sumitomo Pharma Co., Ltd.
LUNESTA, XOPENEX, XOPENEX HFA and BROVANA are registered trademarks of
Sunovion Pharmaceuticals Inc. OMNARIS and ALVESCO are registered trademarks of
Nycomed GmbH, used with permission.

Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Dainippon Sumitomo
Pharma Co., Ltd.^© 2013 Sunovion Pharmaceuticals Inc.

  For a copy of this release, visit Sunovion’s web site at


1 Andreasen NC, Carpenter WT Jr, Kane JM, Lasser RA, Marder SR, Weinberger DR,
Am J Psychiatry 2005;162:441–9.

2 Regier DA, Narrow WE, Rae DS, Mandercheid RW, Locke B2, Goodwin, FK. The de
Facto US Mental and Addictive Disorders Service System. Arch Gen Psychiatry.
1993;50:85-94. Calculated by extrapolating from the 2008 United States Census
Bureau population estimates.

3 National Alliance on Mental Illness. Schizophrenia. [Internet]. Available
form: Accessed May 20, 2013. (To Access: Inform
Yourself, About Mental Illness, Mental Illnesses, Schizophrenia).


Sunovion Pharmaceuticals Inc.
Patricia Moriarty, 508-787-4279
Senior Director, Corporate Communications
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