By IB Times Staff Reporter: Subscribe to IB's RSS feed
August 31, 2010 8:17 AM EDT
Reckitt Benckiser Group Plc on Tuesday said its pharmaceutical unit has got US Food and Drug Administration (FDA) approval to make and sell its new drug Suboxone sublingual film to treat opiod dependence.
The specialty pharmaceutical company said the new drug has been developed using MonoSol Rx's proprietary PharmFilm technology through an agreement, to provide the opioid dependence treatment Suboxone in a fast-dissolving sublingual film.
The company said Suboxone sublingual film will be available from early October to patients in same doses as currently offered by Suboxone (buprenorphine and naloxone) sublingual tablets C-III.
Suboxone sublingual film helps maintain treatment of opioid dependence and should be used as part of a complete treatment plan to include counselling and psychosocial support, it said.
"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," said Shaun Thaxter, president of Reckitt Benckiser Pharmaceuticals Inc, in a statement.
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Reckitt Benckiser Pharmaceuticals Inc makes and sells Suboxone (buprenorphine and naloxone) C-III sublingual tablets and Subutex (buprenorphine) C-III sublingual tablets and formulations of buprenorphine used to treat opioid dependence.
MonoSol Rx's PharmFilm technology is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs.
The company has also issued some safety norms for administering its Suboxone sublingual film. It has warned patients against taking this drug for those hypersensitive to buprenorphine or naloxone while cautioning that 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, it said.
Suboxone sublingual film can also 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 (sedatives, tranquilisers, or alcohol), the company said.
The pharma company said the new drug is extremely dangerous to self-administer nonprescribed benzodiazepines or other CNS depressants while taking Suboxone sublingual film and that liver function should be monitored before and during treatment.
Opioid dependence is a medical diagnosis characterized by an individual's inability to stop using opioids (morphine/heroin, codeine, oxycodone, hydrocodone, etc) even when it is in his or her best interest to do so.
At 8:52 BST, shares of Reckitt Benckiser rose about 1.8 percent to 3,247 pence on the London Stock Exchange.
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