Reckitt Benckiser plc announced today that its new treatments for
opiate dependence, Suboxone(R) (buprenorphine/naloxone) and
Subutex(R) (buprenorphine) 2mg and 8mg tablets have been approved by
the US Food and Drug Administration for the treatment of opiate
dependence. These products were developed under a Cooperative
Research and Development Agreement between Reckitt Benckiser and the
National Institutes of Health's National Institute on Drug Abuse in
the USA over the past ten years.
Subutex and Suboxone will become useful additions to the available
range of pharmacotherapies that can help opiate-dependent patients
overcome their addiction. The major benefit of Subutex/Suboxone is
that qualified physicians in the US will now be able to treat
patients with these products in the privacy of the Doctor's office
rather than only from the limited number of existing drug treatment
programs.
Subutex first received marketing approval in France and was launched in
February 1996 by Schering-Plough under licence from Reckitt
Benckiser. Since then the product has been launched in 24 countries.
Licence income from these sales forms a modest but growing
contribution to Reckitt Benckiser's core Health & Personal Care
category.
For further information
For further information on Suboxone, www.suboxone.com
Call 1-877-SUBOXONE
For further information on Reckitt Benckiser plc www.reckittbenckiser.com
Announcement in Detail
FIRST NEW ADDICTION TREATMENT PRODUCTS IN 30 YEARS APPROVED FOR
IN-OFFICE TREATMENT
Qualified Physicians Have New Weapon to treat addicted patients With
Office-Based, Private Treatment Regimen
Reckitt Benckiser plc (RB.L) announced today that the U.S. Food and
Drug Administration (FDA) has granted marketing approval for
SUBOXONE(R) (buprenorphine hydrochloride/naloxone hydrochloride) and
SUBUTEX(R) (buprenorphine hydrochloride), sublingual tablets for the
treatment of opioid dependence.
SUBOXONE and SUBUTEX are the first therapies approved for in-office
prescribing under the federal Drug Addiction Treatment Act of 2000
(DATA). The new medications and the new in-office model offer a
discreet, effective and convenient new treatment option.
"The approval of SUBOXONE and SUBUTEX is a much anticipated step toward
opening up access to treatment for patients with opioid dependence
who currently have little or no treatment options," said Herbert D.
Kleber, MD, professor of psychiatry and director, Division of
Substance Abuse at the College of Physicians and Surgeons of Columbia
University and the New York State Psychiatric Institute. "These
treatments have potential for tremendous impact in combating opioid
dependence, especially in formerly underserved communities."
There are up to one million opioid-addicted patients in the U.S.,
including those who are addicted to heroin and prescription pain
medications. The estimated annual cost to society of opioid addiction
is more than $20 billion.
The problem affects people in a variety of communities. Only about 15
percent of these heroin-dependent individuals are in treatment,
partly because of limited access to treatment centers, which, until
now, were among the only places to offer treatment. In addition to
lack of access and privacy, current options for treating opioid
dependence often have a high rate of relapse and can be fraught with
other problems.
"People addicted to opioids like heroin and prescription pain
medications are faced with a number of obstacles to getting effective
treatment," said Dr. Kleber. "We need to change the way we think
about addiction. Science has shown that opioid addiction is a
chronic, relapsing brain disease, not a character flaw, failure of
will or lack of self-control. So we need to stop talking about
'addicts' and start referring to them as 'patients' - people who have
a disease that medication can relieve."
SUBOXONE and SUBUTEX
SUBOXONE is a combination of two proven medications, buprenorphine and
naloxone. Buprenorphine, a partial opioid agonist, reduces
withdrawal symptoms and blocks the effects of subsequently
administered opioids, which suggests that it may help reduce illicit
opioid use. Because it contains naloxone, SUBOXONE is highly likely
to produce intense withdrawal symptoms if misused intravenously by
opioid-addicted individuals, however, when used as prescribed
naloxone has no effect.
SUBOXONE has demonstrated a low treatment dropout rate in clinical
trials. Since SUBOXONE is a partial agonist, withdrawal upon
discontinuation is milder than with full agonists. SUBOXONE also
exhibits a "ceiling effect" on respiratory depression, which provides
a margin of safety in comparison to other opioids. This "ceiling
effect" decreases the danger of overdose. Unlike SUBOXONE, SUBUTEX
contains no naloxone; patients may be prescribed SUBUTEX during a
short induction period, which will be closely supervised by their
physician, before being switched to SUBOXONE.
Physician Certification
DATA enables physicians who meet certain qualifying criteria to
prescribe Schedules III, IV, or V narcotic drugs in the privacy of
their offices. Under the DATA, qualified physicians can manage a
total of 30 patients at one time. Further announcements regarding
availability will be provided later.
SUBOXONE Clinical Studies
In a comparative study, adverse event profiles were similar for
subjects treated with 16 mg SUBOXONE or 16 mg SUBUTEX. The following
adverse events were reported to occur by at least 5% of patients in a
4-week study.
The most common adverse events associated with SUBOXONE and placebo
were respectively: headache (36 percent vs. 22 percent); withdrawal
syndrome (25 percent vs. 37 percent); pain (23 percent vs. 19
percent); nausea (15 percent vs. 11 percent); and sweating (14
percent vs. 10 percent).
As with other opioid agonists, there is a risk of respiratory
depression. Patients should be warned of the potential danger of not
using SUBOXONE or SUBUTEX according to product information labeling
and physician instructions.
SUBOXONE and SUBUTEX were developed by Reckitt Benckiser plc, U.K., and
Richmond, VA.
For Financial / Investor and General Corporate Queries
Tom Corran Reckitt Benckiser plc +44 1753 217 800
For Medical, Physician and US queries
Kevin Sangsland Hill & Knowlton + 1 212 885 0507
For more information about SUBOXONE and
SUBUTEX, please see full product information and visit
www.suboxone.com or call 1-877-SUBOXONE
For more information on Reckitt Benckiser please visit
www.reckittbenckiser.com.
Editor's Note:
Under the Drug Addiction Treatment Act (DATA) of 2000, a physician is
qualified to prescribe Schedules III, IV, or V narcotic drugs that
are FDA-approved for the treatment of opioid dependence by meeting
one or more of the following criteria:
- Has been an investigator in one or more clinical trials
leading to the approval of a Schedule III, IV, or V narcotic
drug indicated for the treatment of opioid dependence
- Has been subspecialty board-certified in addiction psychiatry
by the American Board of Medical Specialties
- Has been subspecialty board-certified in addiction medicine by
the American Osteopathic Association
- Holds addiction certification from the American Society of
Addiction Medicine
- Has completed no fewer than 8 hours of approved medical
society training in the treatment and management of opioid
dependence
- Has other such training/experience as the State Medical-
licensing Board or Secretary of Health and Human Services
deems appropriate
Reckitt Benckiser plc
Reckitt Benckiser Healthcare's involvement in prescription drugs is a
legacy of Reckitt & Colman's involvement in basic new chemical entity
research in the 1960's and 1970's. Reckitt Benckiser Healthcare now
focuses mainly on Over-the-Counter medicines such as Gaviscon,
Lemsip, Disprin, Senokot and Fybogel.
Reckitt Benckiser plc is the world's largest household cleaning product
company (excluding laundry detergent) with net revenues in 2001 of
3.4bn pounds stirling ($5.25bn) and net income of 340m pounds
stirling ($525m). The Company has many world leading positions
including in disinfecting cleaning (Lysol, Dettol), Automatic
Dishwashing (Finish, Electrasol, Jet Dry), Fabric Treatment (Vanish,
Spray 'n Wash), Fine Fabric (Woolite) and Depilatories (Veet) and is
a major player in Air Care (Air Wick, Wizard). Reckitt Benckiser
operates in some 60 countries, has sales in some 180 countries and is
headquartered in the UK. Reckitt Benckiser plc is listed on the
London Stock Exchange.
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