US FDA MARKETING APPROVAL FOR
`RECKITT BENCKISER'S SUBUTEXâ & SUBOXONEâ
`
`9th October 2002
`
`Reckitt Benckiser plc announced today that its new treatments for opiate
`dependence, Suboxoneâ (buprenorphine/naloxone) and Subutexâ (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
`Reckitt Benckiser
`Tom Corran
`SVP Investor Relations & Corporate Communications
`Medical, Physician, US Queries
`Hill & Knowlton
`Kevin Sangsland
`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
`
`+44 (0)1753 217 800
`
`+1 212 885 0507
`
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`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 SUBOXONEâ
`(buprenorphine
`hydrochloride/naloxone
`hydrochloride)
`and
`SUBUTEXâ
`(buprenorphine hydrochloride), sublingual tablets for the treatment of opioid
`dependence.
`in-office
`therapies approved for
`the first
`SUBOXONE and SUBUTEX are
`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
`
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`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
`For Medical, Physician and US queries
`+1 212 885 0507
`Kevin Sangsland
`Hill & Knowlton
`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.
`
`+44 1753 217 800
`
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`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.
`
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