Regulatory Approval
9thOctober 2002
US FDA MARKETING APPROVAL FOR
RECKITT BENCKISER'S SUBUTEX®& SUBOXONE®
Reckitt Benckiser plc announced today that its new treatments for opiate
dependence, Suboxone® (buprenorphine/naloxone) and Subutex® (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 24countries. Licence income from these
sales formsa modest but growing contribution to Reckitt Benckiser's core Health
& Personal Care category.
For further information
Tom Corran Reckitt Benckiser
SVP Investor Relations & Corporate Communications +44 (0)1753 217 800
Medical, Physician, US Queries
Kevin Sangsland Hill & Knowlton +1 212 885 0507
For further information on Suboxone
www.suboxone.com
Call Centre at +1-877 437 3314
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®
(buprenorphine hydrochloride/naloxone hydrochloride) and SUBUTEX®
(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 centre on +1-877 437 3314
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 ($5.25bn) and
net income of £340m ($525m). The COmpany has many world leading positions
including in disinfecting cleaning (Lysol, Dettol), Automatic Dishwashing
(Finish, Electrasol, Jet Dry), Fabric Treatment (Vanish, Spray `nWash), 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.