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IRVINE, Calif.(BUSINESS WIRE)
Allergan, Inc. (NYSE: AGN) today announced that the United States Food
and Drug Administration (FDA) has approved BOTOX (onabotulinumtoxinA)
for the treatment of increased muscle stiffness in the elbow, wrist and
fingers in adults with upper limb spasticity.
Spasticity is a debilitating condition impacting approximately 1 million
Americans1, many of whom suffer from spasticity in the upper
limbs following a stroke. Upper limb spasticity may also occur following
a spinal cord or traumatic brain injury or in patients affected by
multiple sclerosis or adults with a history of cerebral palsy.
Although not a life-threatening condition, upper limb spasticity can be
severely debilitating and painful, producing disfiguring muscle
contractions that can result in stiff, tight muscles in the elbow, wrist
and fingers, or a clenched fist. This stiffness hinders a patient's
ability to perform simple tasks, such as dressing or washing the hand,
and often leaves the patient dependent on a caregiver to help with
simple activities.
Upper limb spasticity can manifest weeks, months or even years after
the original injury, possibly after a patient has stopped seeing a
neurologist, physiatrist or their rehabilitation specialist, which is
why it is severely undertreated and there's a low awareness of the
condition,? said Mitchell F. Brin, MD, Allergan's Senior Vice President
Global Development, Chief Scientific Officer, BOTOX. The
approval of BOTOX marks another important evolution in
medical care, as we look to raise greater recognition and understanding
of upper limb spasticity among patients affected by the condition, and
refer them to a neurologist or physiatrist to explore their various
treatment options.?
In patients diagnosed with upper limb spasticity, BOTOX is
injected by a trained specialist directly into the affected muscles,
blocking overactive nerve impulses that trigger these disabling
contractions to reduce the severity of increased muscle tone in the
elbow, wrist and fingers. In clinical studies, the efficacy of BOTOX
persisted up to three months on average. BOTOX is the first
and only neurotoxin approved by the FDA for the treatment of upper limb
spasticity.
Clinical Studies Evaluating BOTOX For the
Treatment of Upper Limb Spasticity
Allergan has conducted multiple studies evaluating the use of BOTOX
to treat upper limb spasticity, including three double-blind,
placebo-controlled studies, two of which were published in The New
England Journal of Medicine,2 and Archives of Physical
and Medical Rehabilitation3.
The first double-blind, placebo-controlled trial compared the safety and
efficacy of BOTOX treatment (200-240 units (U)) with placebo
over a 12-week period in 126 patients who had suffered a stroke at least
6 months prior and experienced increased wrist and finger flexor tone
(scores of at least 3 for wrist flexor tone and at least 2 for finger
flexor tone based on the Ashworth Scale). The Ashworth Scale is a
globally accepted measure of muscle tone4, which rates
passive movement from 1 (normal muscle tone) to 4 (extreme increase in
muscle tone).
The study found that BOTOX neurotoxin produced a
statistically significant reduction in both wrist flexor and finger
flexor muscle tone seen at the week six primary endpoint (P < .05 versus
placebo).5,6 Further, evaluation by the Physician's Global
Assessment score, an investigator's measure of a patient's response to
treatment, correlated with the Ashworth scores, showing a statistically
significant difference favoring BOTOX versus placebo at the
primary endpoint (week 4).7,8
The second study compared three doses of BOTOX (360 U, 180
U, 90 U) with placebo over 24 weeks in 91 patients at least 6 weeks
post-stroke with increased elbow flexor and wrist flexor tone (a score
of at least 2 for elbow flexor tone and at least 3 for wrist flexor tone
based on an expanded Ashworth Scale). 9,10 In this study, the
360 U group achieved statistically significant reduction versus placebo
in wrist flexor tone at the week 6 primary endpoint.
Similar results were observed in a clinical study that compared the same
dosing regimens of BOTOX (360 U, 180 U, 90 U) with placebo
over 12 weeks in 88 patients at least 6 weeks post-stroke with increased
elbow tone and wrist and/or finger tone (scores of at least 2 for elbow
flexor tone and at least 3 for wrist and/or finger flexor tone based on
the Ashworth Scale)11. This study showed BOTOX
decreased muscle tone and achieved statistically significant decreases
in wrist flexor tone, finger flexor tone and elbow flexor tone in the
360 U group at week 412.
For patients who suffer from upper limb spasticity, simple activities
can be so challenging they must rely on a caregiver to pry open their
hand and stretch back their fingers so they can wash their hands or get
dressed,? said Allison Brashear, M.D., Professor and Chair, Department
of Neurology at Wake Forest University Baptist Medical Center in
Winston-Salem, NC. In the clinical studies, we saw improvement in
muscle tone in patients injected with BOTOX, which was
maintained for up to three months with no further injection.?
In the double-blind, placebo-controlled studies of BOTOX for
the treatment of upper limb spasticity, the most common adverse events
occurred in less than 7 percent of patients and included pain in
extremity, fatigue, muscle weakness, nausea and bronchitis .13
About BOTOX
BOTOX is a prescription-only medical product that contains
tiny amounts of highly purified botulinum toxin protein refined from the
bacterium, Clostridium botulinum. BOTOX has a unique,
protected molecular structure that stabilizes the core toxin in BOTOX
from degradation. When injected at approved and labeled doses into a
specific muscle or gland, BOTOX neurotoxin is
expected to diffuse locally and expected to produce a safe and effective
result by producing a localized and temporary reduction in the
overacting muscle or gland, usually lasting up to approximately 3 to 6.7
months depending on the individual patient and indication. Specifically,
the incidence of immunogenicity in patients treated with BOTOX
for upper limb spasticity is 0.53%.
BOTOX was first approved by the FDA 20 years ago for the
treatment of strabismus and blepharospasm, two eye muscle disorders,
making it the first botulinum toxin type A product approved in the
world. Since its first approval, BOTOX has been recognized
by regulatory authorities worldwide as an effective treatment for 21
different indications in approximately 80 countries, benefiting patients
worldwide. In the United States, BOTOX is also approved to
treat the abnormal head position and neck pain that happens with
cervical dystonia (CD) in adults, and to treat the symptoms of severe
underarm sweating (severe primary axillary hyperhidrosis) when medicines
used on the skin (topical) do not work well enough.
In addition to its therapeutic uses, the same formulation of BOTOX
with dosing specific to glabellar lines was approved by the FDA in 2002
under the trade name BOTOX Cosmetic (onabotulinumtoxinA).
The FDA approval of BOTOX for the treatment of upper limb
spasticity in adult patients marks the fifth therapeutic indication for
the product in the United States since 1989.
In addition to 20 years of clinical experience, the safety and efficacy
of BOTOX have been well-established in approximately 50
randomized, placebo-controlled clinical trials and in approximately
11,000 patients treated with BOTOX and BOTOX Cosmetic
in Allergan's clinical trials14. Worldwide, approximately 26
million vials of BOTOX and BOTOX Cosmetic have
been distributed and approximately 29 million treatment sessions have
been performed over the past 20 years (1989-2009)15. With
approximately 2,100 articles on BOTOX and BOTOX
Cosmetic in scientific and medical journals,16 BOTOX neurotoxin
is one of the most widely researched medicines in the world.
BOTOX is a prescription medicine that is
injected into muscles and used:
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to treat increased muscle stiffness in elbow, wrist, and finger
muscles in adults with upper limb spasticity.
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to treat the abnormal head position and neck pain that happens with
cervical dystonia (CD) in adults.
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to treat certain types of eye muscle problems (strabismus) or abnormal
spasm of the eyelids (blepharospasm) in people 12 years and older.
BOTOX is also injected into the skin to treat
the symptoms of severe underarm sweating (severe primary axillary
hyperhidrosis) when medicines used on the skin (topical) do not work
well enough.
BOTOX Cosmetic is a prescription
medicine that is injected into muscles and used to improve the look of
moderate to severe frown lines between the eyebrows (glabellar lines) in
adults younger than 65 years of age for a short period of time
(temporary).
It is not known whether BOTOX is safe or effective in
children younger than:
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18 years of age for treatment of spasticity
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16 years of age for treatment of cervical dystonia
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18 years of age for treatment of hyperhidrosis
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12 years of age for treatment of strabismus or blepharospasm
BOTOX Cosmetic is not recommended for
use in children younger than 18 years of age.
It is not known whether BOTOX and BOTOX
Cosmetic are safe or effective for other types of muscle spasms or
for severe sweating anywhere other than your armpits.
IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING:
BOTOX and BOTOX
Cosmetic may cause serious side effects that can be life
threatening. Call your doctor or get medical help right away if you have
any of these problems after treatment with BOTOX
or BOTOX Cosmetic:
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Problems swallowing, speaking, or breathing. These problems can
happen hours to weeks after an injection of BOTOX
or BOTOX Cosmetic usually because the
muscles that you use to breathe and swallow can become weak after the
injection. Death can happen as a complication if you have severe
problems with swallowing or breathing after treatment with BOTOX
or BOTOX Cosmetic.
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Swallowing problems may last for several months. People who already
have swallowing or breathing problems before receiving BOTOX
or BOTOX Cosmetic have the
highest risk of getting these problems.
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Spread of toxin effects. In some cases, the effect of botulinum
toxin may affect areas of the body away from the injection site and
cause symptoms of a serious condition called botulism. The symptoms of
botulism include: loss of strength and muscle weakness all over the
body, double vision, blurred vision and drooping eyelids, hoarseness
or change or loss of voice (dysphonia), trouble saying words clearly
(dysarthria), loss of bladder control, trouble breathing, trouble
swallowing.
These symptoms can happen hours to weeks after you receive an injection
of BOTOX or BOTOX
Cosmetic.
There has not been a confirmed serious case of spread of toxin effect
away from the injection site when BOTOX has
been used at the recommended dose to treat severe underarm sweating,
blepharospasm, or strabismus, or when BOTOX
Cosmetic has been used at the recommended dose to treat frown lines.
Do not take BOTOX or BOTOX Cosmetic
if you: are allergic to any of the ingredients in BOTOX or
BOTOX Cosmetic. See the end of this
Medication Guide for a list of ingredients in BOTOX and
BOTOX Cosmetic; had an allergic
reaction to any other botulinum toxin product such as Myobloc
or Dysport?, have a skin infection at the planned
injection site.
Tell your doctor about all your medical conditions, including if you
have: a disease that affects your muscles and nerves (such as
amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia
gravis or Lambert-Eaton syndrome).
Tell your doctor about all the medicines you take, including
prescription and nonprescription medicines, vitamins and herbal products.
BOTOX and BOTOX Cosmetic
may cause loss of strength or general muscle weakness, or vision
problems within hours to weeks of taking BOTOX
or BOTOX Cosmetic. If this happens,
do not drive a car, operate machinery, or do other dangerous activities.
BOTOX can cause serious side effects. Other
side effects of BOTOX or BOTOX
Cosmetic include: dry mouth, discomfort or pain at the injection
site, tiredness, headache, neck pain, and eye problems, double vision,
blurred vision, decreased eyesight, drooping eyelids, swelling of your
eyelids, and dry eyes. Symptoms of an allergic reaction to BOTOX
or BOTOX Cosmetic may
include: itching, rash, red itchy welts, wheezing, asthma symptoms, or
dizziness or feeling faint. Tell your doctor or get medical help right
away if you are wheezing or have asthma symptoms, or if you become dizzy
or faint.
Tell your doctor if you have any side effect that bothers you or that
does not go away.
For additional information refer to the Medication Guide. This
Medication Guide summarizes the most important information about BOTOX
or BOTOX Cosmetic. If you would
like more information, talk with your doctor.
Forward-Looking Statement
This press release contains forward-looking statements,? including the
statements by Dr. Brin, and other statements regarding the safety,
effectiveness, approvals, adverse events and market potential of BOTOX
and BOTOX Cosmetic. These statements are based on
current expectations of future events. If underlying assumptions prove
inaccurate or unknown risks or uncertainties materialize, actual results
could vary materially from Allergan's expectations and projections.
Risks and uncertainties include, among other things, general industry
and pharmaceutical market conditions; technological advances and patents
attained by competitors; challenges inherent in the research and
development and regulatory processes; challenges related to product
marketing, such as the unpredictability of market acceptance for new
products and/or the acceptance of new indications for such products;
inconsistency of treatment results among patients; general economic
conditions; and governmental laws and regulations affecting domestic and
foreign operations. Allergan expressly disclaims any intent or
obligation to update these forward-looking statements except as required
by law. Additional information concerning these and other risk factors
can be found in press releases issued by Allergan, as well as Allergan's
public periodic filings with the Securities and Exchange Commission,
including the discussion under the heading Risk Factors? in Allergan's
2009 Form 10-K. Copies of Allergan's press releases and additional
information about Allergan is available on the World Wide Web at www.Allergan.com
or you can contact the Allergan Investor Relations department by calling
(714) 246-4636.
About Allergan, Inc.
Founded in 1950, Allergan, Inc., with headquarters in Irvine,
California, is a multi-specialty health care company that discovers,
develops and commercializes innovative pharmaceuticals, biologics and
medical devices that enable people to live life to its greatest
potential to see more clearly, move more freely, express themselves
more fully. The Company employs more than 8,000 people worldwide and
operates state-of-the-art R&D facilities and world-class manufacturing
plants. In addition to its discovery-to-development research
organization, Allergan has global marketing and sales capabilities with
a presence in more than 100 countries.
2010 Allergan, Inc. Irvine, CA 92612. marks
owned by Allergan, Inc.
Myobloc is a registered
trademark of Solstice Neurosciences, Inc.
Dysport? is owned by
Tercica, Inc., a subsidiary of the Ipsen Group
1 Allergan data on file; Global Literature & Information
Services
2 Brashear A, Gorden MF, Elovic E, et al; for BOTOX
Post-Stroke Spasticity Study Group. Intramuscular injection of botulinum
toxin for the treatment of wrist and finger spasticity after a stroke. N
Engl J Med. 2002;347(6):395-400
3 Childers MK, Brashear A, Jozefczyk P, Reding M,
Alexander D, Good D, Walcott JM, Jenkins SW, Turkel C, Molloy PT.
Dose-dependent response to intramuscular botulinum toxin type A for
upper-limb spasticity in patients after a stroke. Arch Phys Med Rehabil
2004;85:10639.
4 BOTOX Prescribing Information
5 Brashear A, Gorden MF, Elovic E, et al; for BOTOX
Post-Stroke Spasticity Study Group. Intramuscular injection of botulinum
toxin for the treatment of wrist and finger spasticity after a stroke. N
Engl J Med. 2002;347(6):395-400
6 Data on file, Allergan, Inc. 2009. CSR 191622-008,
Table 11.4.1.4-1
7 Brashear A, Gorden MF, Elovic E, et al; for BOTOX
Post-Stroke Spasticity Study Group. Intramuscular injection of botulinum
toxin for the treatment of wrist and finger spasticity after a stroke. N
Engl J Med. 2002;347(6):395-400
8 Data on file, Allergan, Inc., 2009. CSR 191622-008,
Table 11.4.1.2-1
9 BOTOX Prescribing Information
10 BOTOX Prescribing Information
11 BOTOX Prescribing Information
12 CSR BTOX 412-422-8051
13 BOTOX Prescribing Information
14 Allergan data on file; Medical Affairs
15 Allergan data on file; Global Regulatory Affairs
16 Allergan data on file; Global Literature &
Information Services
Allergan Contacts
Caroline Van Hove, 714-246-5134 (media)
Crystal
Muilenburg, 714-246-5842 (media)
Jim Hindman, 714-246-4636
(investors)
Joann Bradley, 714-246-4766 (investors)
Emil
Schultz, 714-246-4474 (investors)
Source: Allergan, Inc.
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