EU Scientific Committee Recommends Approval of Cymbalta(R) For the Treatment of Diabetic Peripheral Neuropathic Pain
February 18 2005 - 4:11AM
PR Newswire (US)
EU Scientific Committee Recommends Approval of Cymbalta(R) For the
Treatment of Diabetic Peripheral Neuropathic Pain Committee Makes
Recommendation After Reviewing Data Package Supporting the
Product's Safety and Efficacy Profile INDIANAPOLIS, Indiana,
February 18 /PRNewswire-FirstCall/ -- The medical advisory board of
the European Medicines Agency (EMEA), which regulates
pharmaceuticals in Europe, has recommended the approval of
duloxetine hydrochloride (sold in the United States as Cymbalta) as
safe and effective for the management of diabetic peripheral
neuropathic pain (DPNP) in adults, Eli Lilly and Company announced
today. If, as expected, the European Commisssion accepts the
recommendation of its Committee for Medicinal Products for Human
Use (CHMP), it would be the second major approval of Cymbalta for
the management of DPNP, following the September 2004 approval by
the U.S. Food and Drug Administration. Also, the drug was twice
approved as safe and effective for other major medical conditions
in Europe - once under the name Yentreve(R), for the treatment of
moderate-to-severe stress urinary incontinence, and once as
Cymbalta, for the treatment of major depressive episodes[1].
Duloxetine is not approved in the United States for the treatment
of stress urinary incontinence. "This regulatory opinion could soon
pave the way for a new safe and effective treatment in Europe for a
very debilitating condition," said Dan Ziegler, M.D., German
Diabetes Clinic of the German Diabetes Research Center, M.D. "Many
people with diabetic peripheral neuropathic pain are elderly, have
multiple health problems and are on multiple medications." Although
it does not change the underlying nerve damage caused by diabetic
peripheral neuropathy, Cymbalta does help relieve the burning,
stabbing and shooting pain that is the hallmark of this condition.
In addition to its once-a-day dosing schedule, Cymbalta is not a
controlled substance, unlike some other medications used to manage
DPNP. The CHMP, which comprises regulators from the 25 European
Union countries, based its positive opinion on its review of the
comprehensive data package that included, in part, data from two
randomized, 12-week, double-blind, placebo-controlled, fixed-dose
studies of 60 and 120 mg per day, in 791 non-depressed adults who
had the disorder for at least six months. In both studies,
duloxetine significantly reduced 24-hour average pain, compared
with placebo. Improvements were noted as early as the first week of
treatment and continued for the duration of the studies. In
addition, duloxetine showed rapid onset of action and effect in
reducing pain caused by diabetic neuropathy at both 60mg per day
and 120mg per day, and was effective in relieving pain at night[2].
Nighttime pain is especially troublesome to many patients with
diabetic neuropathy because it can interfere with sleep. On
average, patients in the studies were 60 years old, suffered from
diabetes for 11 years and related diabetic neuropathy for four
years, and rated their pain as moderate to moderately severe at the
start of the trials. Following the CHMP's positive opinion for
duloxetine for diabetic peripheral neuropathic pain, the European
Commission is expected to grant marketing authorization within the
next few months. About Cymbalta Serotonin and norepinephrine are
two neurotransmitters, or chemical messengers, believed to help
regulate a person's emotions and sensitivity to pain. Research
suggests that increasing levels of serotonin and norepinephrine in
the brain and spinal cord can reduce the body's sensation of pain
from the nerve damage caused by diabetes. Based on preclinical
data, Cymbalta (pronounced sim-BAWL'-tuh) is a balanced and potent
reuptake inhibitor of serotonin and norepinephrine[3]. It is
indicated in the United States for the treatment of major
depression and the management of diabetic peripheral neuropathic
pain. The European Commission has also approved duloxetine for the
treatment of major depression and moderate-to-severe stress urinary
incontinence in adults. As duloxetine has not been studied in
children, Lilly discourages its use in those under 18. Cymbalta
should not be confused with Symbyax(TM) (pronounced SIMM-bee-ax), a
medicine for bipolar depression also marketed by Lilly. Symbyax is
a combination of olanzapine, the active ingredient in Zyprexa(R),
and fluoxetine, the active ingredient in Prozac(R). Symbyax is
available in capsules of 6 mg/25 mg (olanzapine/fluoxetine), 12
mg/25 mg, 6 mg/50 mg and 12 mg/50 mg. Cymbalta is available in 20
mg, 30 mg and 60 mg capsules. Important Safety Information In
clinical studies, antidepressants increased the risk of suicidal
thinking and behavior in children and adolescents with depression
and other psychiatric disorders. Anyone considering the use of
Cymbalta or any other antidepressant in a child or adolescent must
balance the risk with the clinical need. Patients who are starting
therapy should be observed closely. Families and caregivers should
discuss with the doctor any observations of worsening depression
symptoms, suicidal thinking and behavior, or unusual changes in
behavior. Cymbalta is not approved for use in patients under the
age of 18. Patients on antidepressants and their families or
caregivers should watch for worsening depression symptoms, unusual
changes in behavior and thoughts of suicide, as well as for
anxiety, agitation, panic attacks, difficulty sleeping,
irritability, hostility, aggressiveness, impulsivity, restlessness,
or extreme hyperactivity. Call the doctor if you have thoughts of
suicide or if any of these are severe or occur suddenly. Be
especially observant at the beginning of treatment or whenever
there is a change in dose. Prescription Cymbalta is not for
everyone. People who are allergic to duloxetine hydrochloride or
the other ingredients in Cymbalta should not take it. If you have
recently taken a type of antidepressant called a monoamine oxidase
inhibitor (MAOI), are taking thioridazine or have uncontrolled
narrow-angle glaucoma, you should not take Cymbalta. Talk with your
doctor before taking Cymbalta if you have liver or kidney problems,
glaucoma or consume large quantities of alcohol. Women who are
pregnant should talk with their doctor before taking Cymbalta.
Breast feeding while taking Cymbalta is not recommended. In
clinical studies of Cymbalta for depression, the most common side
effects were nausea, dry mouth, constipation, decreased appetite,
fatigue, sleepiness, and increased sweating. Cymbalta also is
approved for the management of neuropathic pain associated with
diabetic peripheral neuropathy. In clinical studies of Cymbalta in
these patients, the most common side effects were nausea,
sleepiness, dizziness, constipation, dry mouth, increased sweating,
decreased appetite, and loss of strength or energy. In all clinical
trials, most people were not bothered enough by side effects to
stop taking Cymbalta. Your doctor may periodically check your blood
pressure. Don't stop taking Cymbalta without talking to your
doctor. For full prescribing information, including Boxed Warming,
visit http://www.cymbalta.com/. About Eli Lilly and Company Lilly,
a leading innovation-driven corporation, is developing a growing
portfolio of best-in-class pharmaceutical products by applying the
latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered
in Indianapolis, Ind., Lilly provides answers-through medicines and
information-for some of the world's most urgent medical needs.
Additional information about Lilly is available at
http://www.lilly.com/. P-LLY This press release contains
forward-looking statements about the potential of duloxetine for
the treatment of diabetic neuropathic pain and reflects Lilly's
current beliefs. However, as with any pharmaceutical product, there
are substantial risks and uncertainties in the process of
commercialization. For further discussion of these and other risks
and uncertainties, see Lilly's filings with the United States
Securities and Exchange Commission. Lilly undertakes no duty to
update forward-looking statements. References [1] In November 2002,
Eli Lilly and Company and Boehringer Ingelheim signed a long-term
agreement to jointly develop and commercialize duloxetine
hydrochloride. This partnership covers most countries worldwide
with few exceptions. In the United States, the collaboration
excludes neuroscience indications. In the United States, Cymbalta
for depression and diabetic peripheral neuropathic pain are
marketed by Lilly and Quintiles. [2] Wernicke JF, Lu Y, D'Souza DN,
Waninger A, Tran PV. Duloxetine at doses of 60 mg QD ad 60 mg BID
is effective treatment of diabetic neuropathic pain. Paper
presented at: American Academy of Neurology; April 24-May 1, 2004;
San Francisco, CA. [3] Bymaster F, Dreshfield-Ahmad L, Threlkeld P,
Shaw J, Thompson B, Nelson D, et al. Comparative affinity of
duloxetine and venlafaxine for serotonin and norepinephrine
transporters in vitro and in vivo, human serotonin receptor
subtypes, and other neuronal receptors. Neuropsychopharmacology.
2001;25(6):871-880. DATASOURCE: Eli Lilly and Company and
Boehringer Ingelheim GmbH CONTACT: Refer to: David Shaffer (U.S.)
+1-(317)-651-3710 voice, +1-(877)-656-9084 pager, Jennifer Yoder
(Outside U.S.), +1-(317)-433-3445 voice, +1-(317)-652-0912 mobile
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