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FDA Approves Antidepressant Cymbalta
FDA Approves Antidepressant Cymbalta -- Posted by Gumbo on 12-24-04 06:14
FDA Approves Antidepressant Cymbalta
Agency grants priority approval to first medicine to treat common, painful
complication of diabetes
The U.S. Food and Drug Administration (FDA) has approved the antidepressant
Cymbalta® (duloxetine HCl; pronounced SIM-BALL-TA), judging it safe and
effective for the management of diabetic peripheral neuropathic pain, a
symptom of nerve damage that affects up to 5 million Americans, Eli Lilly
and Company (NYSE: LLY) announced today.
Cymbalta, a balanced and potent serotonin and norepinephrine reuptake
inhibitor, is the first and only FDA-approved treatment for pain caused by
diabetic peripheral neuropathy. This approval came after a six-month
priority review. More than 18 million Americans have diabetes and are at
risk for developing persistent pain - often described as burning, stabbing
or shooting pain - as a result of nerve damage believed to be caused by high
blood sugar.
"It has been a phenomenal month for Lilly, with four drug approvals since
early August," said Sidney Taurel, Lilly's chairman, president and chief
executive officer.1 "Our long-term investment in drug research continues to
pay dividends, both to the company and, more importantly, to patients around
the world suffering from a variety of illnesses."
This is the second time in a month that the FDA has judged Cymbalta a safe
and effective therapy for a major medical disorder. On Aug. 3, the agency
approved Cymbalta as a treatment for major depression in adults. It's
available immediately by prescription in pharmacies across the United States
for the treatment of major depression or pain associated with diabetic
peripheral neuropathy.
Lilly proved Cymbalta's safety and efficacy in the treatment of pain caused
by diabetic peripheral neuropathy at doses of 60 and 120 mg per day in two
randomized, 12-week, double-blind, placebo-controlled, fixed-dose studies in
non-depressed adults who had the disorder for at least 6 months. However,
doses of 120 mg per day, although safe and effective, were not as well
tolerated as 60 mg per day. On average, patients in the studies were 60
years old, suffered from diabetes for 11 years and from related diabetic
neuropathy for four years, and at the beginning of the studies, rated their
pain as moderate to moderately severe.
In both studies, Cymbalta 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,
Cymbalta showed rapid onset of action and sustained effect in reducing pain
caused by diabetic neuropathy at both 60 mg per day and 120 mg per day, and
was effective in relieving pain at night. Nighttime pain is especially
troublesome to many patients with diabetic neuropathy, because it can
interfere with sleep.
"Until now, we didn't have a simple and effective therapy for patients
living with diabetic neuropathic pain. Instead, we were left with
medications that often required multiple dose adjustments, or for patients
to take several pills throughout the day. This is difficult for many of
these patients, as they already take a host of medications for their
diabetes and other conditions, which can put them at increased risk for drug
interactions and dose-limiting side effects," said Timothy Smith, M.D.,
R.Ph., Medical Director, Mercy Health Research, St. Louis, and a Cymbalta
investigator. "With Cymbalta, we finally have a therapy proven to provide
real relief for many of these patients, without the complicated dosing
schedule."
Although Cymbalta does not change the underlying nerve damage caused by
diabetic peripheral neuropathy, it does help relieve the stabbing, burning
and shooting pain often associated with the disorder. Scientists believe it
does this by increasing levels of serotonin and norepinephrine, two
neurotransmitters, or chemical messengers, believed to be important in
regulating a person's emotions as well as sensitivity to pain. Increasing
these levels in a balanced way is thought to improve the body's natural
ability to regulate pain.
"We know that Cymbalta, as an antidepressant, is effective at treating both
the emotional and painful physical symptoms of depression," said Stephen
Stahl, M.D., Ph.D., chairman of the Neuroscience Education Institute and
adjunct professor of psychiatry at the University of California at San Diego
School of Medicine. "Seeing significant benefit in diabetic neuropathic
pain, among patients who did not have depression, helps confirm that this
drug has a positive impact on pain that is separate from improvement in
mood."
About Cymbalta
Cymbalta comes in a capsule and can be taken once a day. The recommended
daily dose for Cymbalta is 60 mg. Cymbalta has not been studied in children,
and therefore Lilly discourages its use in those under 18. In addition to
depression and pain caused by diabetic peripheral neuropathy, duloxetine
hydrochloride, the active ingredient in Cymbalta, also has been approved in
Europe for the treatment of moderate to severe stress urinary incontinence,
another condition believed to respond to treatment that affects serotonin
and norepinephrine levels.
Cymbalta should not be confused with SymbyaxT (pronounced SIMM-bee-ax), a
medicine for bipolar depression also marketed by Lilly. Cymbalta is
available in 20 mg, 30 mg and 60 mg capsules. Symbyax is a combination of
olanzapine, the active ingredient in Zyprexa®, and fluoxetine, the active
ingredient in Prozac®. 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.
About Diabetic Peripheral Neuropathy
According to the National Institute of Diabetes & Digestive & Kidney
Diseases, approximately half of those with diabetes have some form of nerve
damage, or neuropathy, but not all will develop symptoms. While nerve
problems can occur at any time, the highest rates are among those who have
had diabetes for at least 25 years. People who have had problems controlling
their blood sugar levels, have high blood pressure, are overweight, have
high levels of blood fat, or are over the age of 40, may also have a greater
risk of developing diabetic peripheral neuropathy.
Symptoms can include numbness, tingling or pain and weakness in the toes,
feet, legs, hands, arms and fingers. These symptoms are often worse at
night.2
Important Safety Information
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 serious liver or kidney
problems, glaucoma or consume large quantities of alcohol. Women who are
pregnant should talk with their doctor before taking Cymbalta. Nursing while
taking Cymbalta is not recommended.
In clinical studies of Cymbalta for pain caused by diabetic neuropathy, the
most common side effects were nausea, sleepiness, dizziness, constipation,
dry mouth, increased sweating, decreased appetite and fatigue. 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.
Cymbalta is also used to treat depression. Patients being treated with
antidepressants should be observed closely for clinical worsening of
depressive symptoms and suicidality. Patients and their families should
watch for these as well as for anxiety, agitation, panic, difficulty
sleeping, irritability, hostility, aggressiveness, impulsivity,
restlessness, or over excitement and hyperactivity. Call the doctor if any
of these are severe or occur suddenly. Be especially observant when starting
any antidepressant therapy and whenever there is a change in dose.
For full patient information, visit www.Cymbalta.com.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and 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 www.lilly.com.
This press release contains forward-looking statements about the potential
of Cymbalta 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 development and
commercialization. There is no guarantee that the product will prove to be
commercially successful. 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.
--------------------------------------------------------------------------------
1. The four approvals include:
a.. On Aug. 3, the FDA approved Cymbalta for the treatment of major
depressive disorder in adults.
b.. On Aug. 12, YentreveT received approval across the European Union for
the treatment of stress urinary incontinence in women. (Yentreve is a
trademark of Eli Lilly and Company. This trademark is pending approval by
the FDA as a proprietary drug name for the established name, duloxetine
hydrochloride. In November 2002, Eli Lilly and Company and Boehringer
Ingelheim signed a global long-term agreement to jointly develop and
commercialize duloxetine hydrochloride for the treatment of stress urinary
incontinence (SUI), depression and diabetic neuropathic pain. This
partnership covers most countries worldwide with few exceptions. In the
U.S., the collaboration focuses on SUI.)
c.. On Aug. 19, the FDA approved Alimta® (pemetrexed) for the second-line
treatment of advanced lung cancer
d.. On Sept. 3, the FDA approved Cymbalta for the treatment of pain caused
by diabetic peripheral neuropathy.
2. National Diabetes Information Clearinghouse. Diabetic Neuropathies: The
Nerve Damage of Diabetes. National Institute of Diabetes and Digestive and
Kidney Diseases. http://www.diabetes.niddk.nih.gov/dm/pubs/neuropathies/,
August 2004.
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