LEXINGTON, Mass., Jan. 30, 2015 /PRNewswire/ -- Shire plc
(LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Food and
Drug Administration (FDA) approved Vyvanse®
(lisdexamfetamine dimesylate) Capsules (CII), the first and only
medication for the treatment of moderate to severe binge eating
disorder (B.E.D.) in adults, shown to significantly reduce the mean
number of binge days per week. Vyvanse is not indicated or
recommended for weight loss or the treatment of obesity. Other
sympathomimetic drugs used for weight loss have been associated
with serious cardiovascular reactions.
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"Binge eating disorder is the most common adult eating disorder
in the United States, and we are
excited to provide the first FDA-approved treatment for moderate to
severe B.E.D. in adults," said Philip J.
Vickers, Ph.D., Global Head of Research and Development at
Shire. "This new indication for Vyvanse is a critical milestone in
the treatment of this condition and reflects our ongoing commitment
to address the needs of patients."
"The management of B.E.D. is continuously being studied, and
though advancements have been made to increase awareness and
understanding of this real disorder, rates of diagnosis remain
low," said Susan L. McElroy, M.D.,
Professor of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine; and
principal investigator of the B.E.D. clinical trials. "The
development of new treatment options for adults with B.E.D. is
important to the patients who continue to live with this complex
disorder."
The efficacy of Vyvanse in the treatment of B.E.D. was
demonstrated in two 12-week randomized, double-blind, multi-center,
parallel-group, placebo-controlled, dose-optimization studies in
adults aged 18 to 55 years (Study 1: N=374, Study 2: N=350) with
protocol-defined moderate to severe B.E.D. (severity was defined as
having at least 3 binge days per week for 2 weeks prior to the
baseline visit and a Clinical Global Impression Severity score of
greater than or equal to 4 at baseline). The primary efficacy
outcome for the two studies was defined as the change from baseline
at week 12 in the number of binge days per week. Baseline is
defined as the weekly average of the number of binge days per week
for the 14 days prior to the baseline visit.
Subjects from both studies on Vyvanse had a statistically
significant greater reduction from baseline in mean number of binge
days per week at Week 12. In study 1, Vyvanse reduced the mean
number of binge days per week from 4.79 at baseline to 0.78 at
study endpoint compared with 4.60 to 2.22 for placebo. The least
squares mean change from baseline in binge days per week was –3.87
and –2.51 for Vyvanse and placebo, respectively. Similar
results were seen in study 2.
Vyvanse is a federally controlled substance (CII) because it
can be abused or lead to dependence. Keep in a safe place to
prevent misuse and abuse. Selling or sharing Vyvanse may harm
others and is illegal.
Greater improvement across key secondary outcomes was also
observed in subjects treated with Vyvanse as compared to placebo,
including a higher proportion of subjects rated improved on the
Clinical Global Impressions-Improvement (CGI-I) rating scale,
higher proportion of subjects with 4-week binge cessation, and
greater reduction in the Yale-Brown Obsessive Compulsive Scale
Modified for Binge Eating (Y-BOCS-BE) total score in both
studies.
Patients with current anorexia or bulimia nervosa; current
comorbid psychiatric disorder; and cardiovascular risk factors
other than obesity and smoking were excluded from the studies. In
both studies, there were 4 patients each in the Vyvanse and placebo
treated groups who reported serious adverse events (SAEs). There
were no deaths in either of the studies. Of patients treated with
Vyvanse, 5.1% (19/373) discontinued due to adverse reactions
compared with 2.4% (9/372) of placebo-treated patients. The most
common adverse reactions (incidence greater than or equal
to 5% and at least twice placebo) reported in adults with
moderate to severe B.E.D. were dry mouth, insomnia, decreased
appetite, increased heart rate, constipation, feeling jittery, and
anxiety.
About B.E.D.
Binge eating disorder, now recognized as a distinct disorder, is
defined as recurring episodes (greater than or equal to once
weekly, for at least 3 months) of consuming a large amount of food
in a short time, compared with others. Patients feel a lack
of control during a binge eating episode and marked distress over
their eating. They typically experience shame and guilt,
among other symptoms, about their binge eating, and may conceal the
symptoms. 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.
B.E.D. is the most common eating disorder in the United States, affecting an estimated 2.8
million adults, according to a national survey. B.E.D. occurs in
both men and women, and is more common than anorexia and bulimia
combined. B.E.D. can occur in normal weight, overweight, and obese
adults, and is seen across racial and ethnic groups. Medication is
not appropriate for all adults with B.E.D.
More About Vyvanse (lisdexamfetamine dimesylate) B.E.D.
Clinical Trials
In the two 12-week studies, patients were confirmed with a
diagnosis of B.E.D. using DSM-IV-TR® criteria for
B.E.D. For both studies, a binge day was defined as a day with at
least 1 binge episode, as determined from the subject's daily binge
diary and confirmed by the clinician.
About VYVANSE (lisdexamfetamine dimesylate)
INDICATION
Vyvanse is a prescription medicine 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 in a safe place to prevent misuse
and abuse. Selling or sharing Vyvanse may harm others and is
illegal.
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- Do not take Vyvanse if you:
- are taking or have taken within the past 14 days an
anti-depression medicine called a monoamine oxidase inhibitor or
MAOI
- are sensitive to, allergic to, or had a reaction to other
stimulant medicines
- Some people have had the following problems when taking
stimulant medicines, such as Vyvanse:
1.
Heart-related problems including:
- sudden death in people who have heart problems or heart
defects
- sudden death, stroke and heart attack in adults
- increased blood pressure and heart rate
Tell your doctor if you have any heart problems, heart defects,
high blood pressure, or a family history of these problems. The
doctor should check your blood pressure and heart rate regularly
during treatment. Call your doctor right away if you have any
signs of heart problems such as chest pain, shortness of breath, or
fainting while taking Vyvanse.
2.
Mental (psychiatric) problems including:
- new or worse behavior and thought
problems
- new or worse bipolar illness
- new psychotic symptoms such as:
- seeing things or hearing voices that are not real
- believing things that are not true
- being suspicious
Tell your doctor about any drug abuse, alcohol abuse or mental
problems that you have had, or about a family history of suicide,
bipolar illness, or depression.
Call your doctor right away if you have any new or worsening
mental symptoms or problems while taking Vyvanse.
3.
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 your doctor right away if you have any of these signs or
symptoms or develop unexplained wounds on fingers or toes while
taking Vyvanse.
- Tell the doctor if you are pregnant, breast-feeding, or plan to
become pregnant or breast-feed.
- The most common side effects of Vyvanse reported in studies
of adults with moderate to severe B.E.D. were:
- dry mouth
- trouble sleeping
- decreased appetite
- increased heart rate
- constipation
- feeling jittery
- anxiety
For additional safety information, click here for
Prescribing Information and
Medication Guide and discuss with your
doctor.
Shire is committed to helping patients get the Shire medicines
their physician has prescribed and is developing various programs
to extend this commitment to adults with moderate to severe B.E.D.
For more information, please visit www.shire.com.
For further information please contact:
Investor
Relations
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Sarah
Elton-Farr
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seltonfarr@shire.com
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+44 1256 894157
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Media
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Gwen
Fisher
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gfisher@shire.com
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+1 484 595 9836
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NOTES TO EDITORS
Shire enables people with life-altering conditions to lead
better lives.
Our strategy is to focus on developing and marketing innovative
specialty medicines to meet significant unmet patient needs.
We focus on providing treatments in Neuroscience, Rare Diseases,
and Gastrointestinal and Internal Medicine and are developing
treatments for symptomatic conditions treated by specialist
physicians in other targeted therapeutic areas, such as
Ophthalmology.
www.shire.com
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and other risks and uncertainties detailed from time to time in
Shire's or NPS Pharma's filings with the U.S. Securities and
Exchange Commission, including their respective most recent Annual
Reports on Form 10-K.
Vyvanse® (lisdexamfetamine dimesylate) is a
registered trademark of Shire LLC. Vyvanse is available in 10, 20,
30, 40, 50, 60 and 70 mg
capsules.
DSM-5® is a registered trademark of the
American Psychiatric Association.
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