LEXINGTON, Massachusetts,
October 17, 2016 /PRNewswire/ --
Labeling Update
Based on Maintenance of Efficacy Data from a 38-Week
Phase 3 Study
For U.S. Audiences Only - Shire plc (LSE: SHP,
NASDAQ: SHPG) announces an update to the Vyvanse®
(lisdexamfetamine dimesylate) labeling to include information
regarding the approval of a supplemental New Drug Application
(sNDA) by the U.S. Food and Drug Administration (FDA). The labeling
will now include maintenance of efficacy data from SPD489-346, the
first-ever longer-term pharmacologic study (38 weeks) in adults
with moderate to severe binge eating disorder (B.E.D.). Results
from SPD489-346, which were announced in July 2015, indicated that Vyvanse (n=136)
demonstrated significant maintenance of efficacy compared to
placebo (n=131) based upon the primary endpoint of time to relapse
(p<0.001). Vyvanse is approved in the U.S. for adults with
moderate to severe B.E.D. Vyvanse is not for weight loss. It is not
known if Vyvanse is safe and effective for the treatment of
obesity.
"The FDA approval for the labeling update to include maintenance
of efficacy data from the first-ever longer-term pharmacologic
study in adults with moderate to severe B.E.D. advances our
understanding of the efficacy and safety profile of Vyvanse for
adults living with the disorder," said Philip J. Vickers, Ph.D., Global Head of
Research and Development at Shire. "Collectively, the data and
labeling update represent Shire's commitment to supporting patients
and the health care community by expanding the growing body of
research on B.E.D. with longer-term data in this disorder."
In the 26-week, double-blind, placebo-controlled,
randomized-withdrawal phase of this study, relapse was defined as
having two or more binge days per week for two consecutive weeks
prior to any visit and an increase in Clinical Global
Impressions-Severity (CGI-S) score of two or more points relative
to the randomized-withdrawal baseline visit. At the conclusion of
the study, maintenance of efficacy for patients who had an initial
response to Vyvanse during the open-label treatment phase, and then
continued on Vyvanse during the randomized-withdrawal phase, was
demonstrated with Vyvanse being superior over placebo as measured
by time to relapse. The safety profile for Vyvanse in this study,
which evaluated treatment-emergent adverse events (TEAEs) and vital
signs, was generally consistent with the known profile reported in
previous studies in adult patients with moderate to severe
B.E.D.
Vyvanse is a federally controlled substance (CII) because it
can be abused or lead to dependence. Keep Vyvanse in a safe place
to prevent misuse and abuse. Selling or giving away Vyvanse may
harm others, and is against the law.
"These data help health care professionals make more informed
decisions when discussing treatment options for B.E.D. in adults,"
said Susan L. McElroy, M.D.,
Professor of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine.
"Further, the updated Vyvanse labeling with this longer-term
maintenance of efficacy data will offer health care professionals a
better understanding of how the medication may be incorporated into
broader treatment plans for adults with moderate to severe
B.E.D."
Vyvanse is not appropriate for all adults with moderate to
severe B.E.D. Adult patients who think they may have symptoms of
B.E.D. should talk to their health care professional (HCP).
Patients should work with their HCP to develop an appropriate
treatment plan.
About The Study
Study SPD489-346
This Phase 3, 38-week, multi-center, double-blind,
placebo-controlled, randomized-withdrawal study evaluated the
maintenance of efficacy between dose-optimized Vyvanse and placebo
based on the primary endpoint of time to relapse in adults aged 18
to 55 (N=267) with moderate to severe B.E.D. A diagnosis of B.E.D.
was based on the Diagnostic and Statistical Manual of Mental
Disorders, Fourth Edition - Text Revision
(DSM-IV-TR®) criteria.
The study consisted of a four-week screening period and a
12-week open-label treatment phase, followed by a 26-week,
double-blind, placebo-controlled, randomized-withdrawal phase.
During the four-week dose-optimization period, all patients were
initiated on Vyvanse 30 mg per day, and then titrated weekly in 20
mg increments to their optimal dose (either 50 mg or 70 mg per
day). Patients who met response criteria (one or fewer binge days
each week for four consecutive weeks prior to the last visit and
had a CGI-S score of two or less at the same visit) at the end of
the 12-week open-label phase were randomized to Vyvanse or placebo
treatment groups. During this 26-week randomized-withdrawal phase,
patients either continued with the same optimized dose of Vyvanse
(n=136) from the open-label phase or were switched to placebo
(n=131). The primary endpoint was defined as the time to relapse
from randomization. Relapse was defined as having two or more binge
days per week for two consecutive weeks prior to any visit and an
increase in CGI-S score of two or more points relative to the
randomized-withdrawal baseline visit. Vyvanse demonstrated
superiority over placebo based on the primary endpoint of time to
relapse.
The safety profile for Vyvanse in this study, which evaluated
TEAEs and vital signs, was generally consistent with the known
profile reported in previous studies in adult patients with
moderate to severe B.E.D.
During the open-label phase (N=411), three patients experienced
serious adverse events (SAEs) and 22 patients reported TEAEs that
led to study discontinuation. The most commonly reported TEAEs
(reported in 5 percent or more of patients) included dry mouth,
headache, insomnia, decreased appetite, nausea, anxiety,
constipation, hyperhidrosis, feeling jittery, and diarrhea.
During the randomized-withdrawal phase (Vyvanse, n=136; Placebo,
n=134), two patients treated with Vyvanse experienced SAEs and six
patients on Vyvanse reported TEAEs that led to study
discontinuation. The most commonly reported TEAEs (reported in 5
percent or more of patients) in patients taking Vyvanse included
nasopharyngitis, headache, upper respiratory tract infection, and
dry mouth, and in patients taking placebo included nasopharyngitis,
headache, and fatigue.
About B.E.D.
Binge eating disorder (B.E.D.), recognized in the Diagnostic
and Statistical Manual of Mental Disorders, Fifth Edition
(DSM-5®) as a distinct eating disorder in 2013,
is defined as recurring episodes (on average, at least once weekly,
for three months) of consuming an unusually large amount of food in
a short time, compared with what others would consume under the
same or similar circumstances. Adults with B.E.D. feel a sense of
lack of control over eating during a binge eating episode and
marked distress over their binge eating episodes. They typically
experience shame and guilt about their binge eating, among other
symptoms, and may conceal their eating problems. Unlike people with
other eating disorders, adults with B.E.D. don't routinely try to
"undo" their excessive eating with extreme actions like purging or
over-exercising. Only a doctor or other qualified HCP can diagnose
B.E.D. and determine an appropriate treatment plan.
B.E.D. is the most common eating disorder among U.S. adults, and
is more common than anorexia nervosa and bulimia nervosa combined.
The disorder occurs in both men and women, is seen across racial
and ethnic groups in U.S. adults, and can occur in normal weight,
overweight, and obese adults.
About Vyvanse® (lisdexamfetamine
dimesylate)
What is Vyvanse?
Vyvanse is a prescription medicine used for the treatment of
moderate to severe binge eating disorder (B.E.D.) in adults.
Vyvanse is not for weight loss. It is not known if Vyvanse is safe
and effective for the treatment of obesity.
IMPORTANT SAFETY INFORMATION
Vyvanse is a federally controlled substance (CII) because it
can be abused or lead to dependence. Keep Vyvanse in a safe
place to prevent misuse and abuse. Selling or giving away Vyvanse
may harm others, and is against the law.
Vyvanse is a stimulant medicine. Tell the doctor if you have
ever abused or been dependent on alcohol, prescription medicines,
or street drugs.
Who should not take Vyvanse?
Do not take Vyvanse if you are:
- taking or have taken an anti-depression medicine called a
monoamine oxidase inhibitor (MAOI) within the past 14 days
- sensitive or allergic to, or had a reaction to other
stimulant medicines
Problems that can occur while taking Vyvanse. Tell the doctor
if you:
- have heart problems or heart defects, high blood pressure, or a
family history of these problems. This is important because sudden
death has occurred in people with heart problems or defects who
were taking stimulant medicines, and sudden death, stroke and heart
attack have happened in adults taking stimulant medicines. Since
increases in blood pressure and heart rate may occur, the doctor
should regularly check these during treatment. Call the doctor
right away if you have any signs of heart problems such as chest
pain, shortness of breath, or fainting while taking
Vyvanse.
- have mental problems, or a family history of suicide, bipolar
illness, or depression. This is important because new or worsening
behavior and thought problems or bipolar illness may occur. New
symptoms such as seeing or hearing things that are not real,
believing things that are not true, being suspicious, or having new
manic symptoms may occur. Call the doctor right away if there
are any new or worsening mental symptoms during treatment.
- have circulation problems in fingers and toes (peripheral
vasculopathy, including Raynaud's phenomenon). Fingers or toes may
feel numb, cool, painful, sensitive to temperature and/or change
color from pale, to blue, to red. Call the doctor right
away if any signs of unexplained wounds appear on fingers or
toes while taking Vyvanse.
- are pregnant or plan to become pregnant. It is not known if
Vyvanse may harm your unborn baby. Are breastfeeding or plan to
breastfeed. Do not breastfeed while taking Vyvanse. Talk to your
doctor about the best way to feed your baby if you take
Vyvanse.
What are possible side effects of Vyvanse?
The most common side effects of Vyvanse reported in studies of
adults with moderate to severe B.E.D. include:
· dry mouth · constipation
· trouble sleeping · feeling jittery
· decreased appetite
· increased heart rate · anxiety
For additional safety information, click here for
Prescribing Information and
Medication Guide and discuss with your
doctor.
Vyvanse® is a registered trademark of Shire LLC.
Vyvanse is available in 10, 20, 30, 40, 50, 60, and 70 mg capsules.
DSM-IV-TR® and
DSM-5® are registered trademarks of the
American Psychiatric Association.
NOTES TO EDITORS
About Shire
Shire is the leading global biotechnology company focused on
serving people with rare diseases and other highly specialized
conditions. We strive to develop best-in-class products, many of
which are available in more than 100 countries, across core
therapeutic areas including Hematology, Immunology, Neuroscience,
Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal
Medicine/Endocrine and Hereditary Angioedema; and a growing
franchise in Oncology.
Our employees come to work every day with a shared mission: to
develop and deliver breakthrough therapies for the hundreds of
millions of people in the world affected by rare diseases and other
high-need conditions, and who lack effective therapies to live
their lives to the fullest.
http://www.shire.com
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SOURCE Shire plc