Reckitt Benckiser Group plc
Reckitt Benckiser Pharmaceuticals Inc. Receives FDA Approval for Suboxone®
(Buprenorphine and Naloxone) Sublingual Film C-III
Richmond, VA (31st August 2010) - Reckitt Benckiser Pharmaceuticals Inc. today
announces that it has received approval from the U.S. Food and Drug
Administration (FDA) for its New Drug Application (NDA) to manufacture and
market Suboxone® sublingual film. Suboxone® sublingual film has been developed
through an exclusive agreement with MonoSol Rx, utilising its proprietary
PharmFilm® technology, to deliver the opioid dependence treatment Suboxone® in
a fast-dissolving sublingual film.
Suboxone® sublingual film is indicated for maintenance treatment of opioid
dependence and should be used as part of a complete treatment plan to include
counselling and psychosocial support. Prescription use of this product is
limited to physicians certified under the Drug Addiction Treatment Act, 2000.
Suboxone® sublingual film will be available from early October 2010 to patients
in the same doses as currently offered by Suboxone® (buprenorphine and
naloxone) sublingual tablets C-III. A Risk Evaluation and Mitigation Strategy
(REMS) program is being implemented as part of the FDA requirements to ensure
that the benefits of treatment with Suboxone® sublingual film outweigh the
potential risks, particularly risks of accidental overdose, misuse and abuse.
Commenting on the FDA's approval, Shaun Thaxter, President of Reckitt Benckiser
Pharmaceuticals Inc. said: "The development of Suboxone® sublingual film
through our exclusive agreement with MonoSol Rx reinforces our commitment to
our opioid dependence therapy franchise and to its development. During clinical
studies, Suboxone® sublingual film was shown to be faster dissolving than
Suboxone® sublingual tablets. Because of the faster dissolution and the taste
profile, patients preferred the film. Each individual dose of Suboxone®
sublingual film will come in a child-resistant pouch.
Our partnership with MonoSol Rx represents a strategic business opportunity
which will contribute to the longevity of Suboxone® in the U.S."
About Reckitt Benckiser Pharmaceuticals Inc.
Reckitt Benckiser Pharmaceuticals Inc. is a speciality pharmaceutical company
that manufactures and markets Suboxone® (buprenorphine and naloxone [2 mg/0.5
mg and 8 mg/2 mg]) C-III sublingual tablets and Subutex® (buprenorphine [2 mg
and 8 mg]) C-III sublingual tablets, formulations of buprenorphine used to
treat opioid dependence. Reckitt Benckiser Pharmaceuticals Inc. is committed to
expanding access to medical therapies for patients suffering from the chronic,
relapsing brain disease of opioid dependence. For more information, visit
suboxone.com or heretohelp.com. Reckitt Benckiser Pharmaceuticals Inc. is a
wholly-owned subsidiary of Reckitt Benckiser Group plc, a global company
publicly traded on the UK stock exchange.
About MonoSol Rx, LLC
MonoSol Rx, LLC is a speciality pharmaceutical company leveraging its
proprietary PharmFilm® technology to deliver drugs in quick dissolving films.
PharmFilm® is designed to benefit patients by improving the convenience,
efficacy, and compliance of new and currently marketed drugs. The Company's
leadership in thin film drug delivery is supported by strong intellectual
property, a portfolio of commercialised over-the-counter (OTC) drug products,
and a development pipeline of prescription formulations based on PharmFilm®
technology. With a vertically integrated development and production
infrastructure, MonoSol Rx, LLC has the capacity to manufacture OTC drug
products for near-term revenues that fund prescription product development
programmes that will generate long-term value.
The Company's commercialisation strategy for all PharmFilm® products is to
partner with the innovator, other speciality pharma or leading consumer
products companies that can sell-in and manage product sales and marketing. For
existing and future partners, PharmFilm® formulations represent revenue
life-cycle extensions for products with patent lives that have expired or are
approaching expiration. PharmFilm® is a tool to help sales and marketing
partners differentiate in competitive markets while offering unique advantages
over drugs dosed by traditional tablets, capsules and orally disintegrating
tablets (ODTs).
Important Safety Information
Suboxone® (buprenorphine and naloxone) sublingual film (C-III) is indicated for
maintenance treatment of opioid dependence as part of a complete treatment plan
to include counselling and psychosocial support. Treatment should be initiated
under the direction of physicians qualified under the Drug Addiction Treatment
Act.
Suboxone® sublingual film should not be used by patients hypersensitive to
buprenorphine or naloxone.
Suboxone® sublingual film can be abused in a manner to other opioids, legal or
illicit. Clinical monitoring appropriate to the patient's level of stability is
essential.
Chronic use of buprenorphine can cause physical dependence. A sudden or rapid
decrease in dose may result in an opioid withdrawal syndrome that is typically
milder than seen with full agonists and may be delayed in onset.
Suboxone® sublingual film can cause serious life-threatening respiratory
depression and death particularly when taken by the intravenous (IV) route in
combination with benzodiazepines or other central nervous system (CNS)
depressants (ie, sedatives, tranquilisers, or alcohol). It is extremely
dangerous to self-administer nonprescribed benzodiazepines or other CNS
depressants while taking Suboxone® sublingual film. Dose reduction of CNS
depressants, Suboxone® sublingual film, or both when both are being taken
should be considered.
Liver function should be monitored before and during treatment.
Death has been reported in nontolerant, nondependent individuals, especially in
the presence of CNS depressants.
Children who take Suboxone® sublingual film can have severe, possibly fatal,
respiratory depression. Emergency medical care is critical. Keep Suboxone®
sublingual film out of the sight and reach of children.
Intravenous misuse or taking Suboxone® sublingual film before the effects of
full-agonist opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone)
have subsided is highly likely to cause opioid withdrawal symptoms.
Neonatal withdrawal has been reported. Use in pregnant women or during
breast-feeding should be only if the potential benefit justifies the potential
risk. Caution should be exercised when driving vehicles or operating hazardous
machinery, especially during dose adjustment.
Adverse events commonly observed with the sublingual administration of Suboxone
® sublingual film are numb mouth, sore tongue, redness of the mouth, headache,
nausea, vomiting, sweating, constipation, signs and symptoms of withdrawal,
insomnia, pain, swelling of the limbs, disturbance of attention, palpitations
and blurred vision.
Cytolytic hepatitis, jaundice, and allergic reactions, including anaphylactic
shock, have been reported.
This is not a complete list of potential adverse events associated with
Suboxone® sublingual film. Please see full Prescribing Information for a
complete list.
To report an adverse event associated with taking Suboxone® sublingual film,
please call 1-877-782-6966. You are encouraged to report adverse events of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
For further information, please contact:
Reckitt Benckiser Group plc +44 (0)1753 217800
Joanna Speed
Director, Investor Relations
Andraea Dawson-Shepherd
SVP, Global Corporate Communications and Affairs
Reckitt Benckiser Pharmaceuticals Inc.
Harriet Ullman +1 617 761 6776
Feinstein Kean Healthcare
END
RECKITT BENCKISER GROUP PLC
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