FDA Approves Suboxone Sublingual Film
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: Feinstein Kean Healthcare +1 617 761 6776
Posted: August 2010
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