FDA Approves New Opioid Addiction Drug

A Swedish drug maker says it has won approval from the U.S. Food and Drug Administration for a new tablet designed treat addiction to heroin and opioid painkillers.

Orexo expects to launch the drug in the U.S. in September. The tablet, called Zubsolv, combines the drugs buprenorphine and naloxone. It dissolves under the tongue and has a menthol flavor that Orexo says patients prefer over Suboxone, which has long dominated the market for opioid addiction drugs.

Suboxone, which is also made from buprenorphine and naloxone, comes in both a tablet and a film version that dissolves under the tongue. It generated U.S. sales of $1.5 billion for Reckitt-Benckiser, a British pharmaceutical company.

Zubsolv tablets. Image courtesy of Orexo.

Zubsolv tablets. Image courtesy of Orexo.

Naloxone and the opioid buprenorphine are combined to help wean addicts off powerful narcotics such as Vicodin, OxyContin, oxycodone, and hydrocodone. Naloxone is added to block opioid receptors in the brain and central nervous system.

The FDA recently allowed two generic versions of Suboxone to come on the market and Reckitt faces increasing competition from other competitors. Reckitt warned shareholders last year that “up to 80% of the revenue and profit from the suboxone tablet business in the U.S. might be lost.”

Orexo says the market potential for Zubsolv could reach $500 million in sales annually. The company says Zubsolv dissolves faster and has a better taste than Suboxone. In studies, the Zubsolv tablet was preferred by 9 out of 10 participants over Suboxone film, according to Orexo.

“Orexo has developed Zubsolv as a novel sublingual therapy meeting the needs of millions of patients that suffers from opioid dependence to offer them a new choice of treatment. Zubsolv has in previous studies showed a high acceptability compared to the leading treatment modalities in the market. We expect Zubsolv will be well received by patients and prescribers,” said Nikolaj Sørensen, President and CEO of Orexo.

Buprenophine was first approved as a treatment for opioid addiction in the U.S. in 2002. Over three million Americans with opioid dependence have been treated with Suboxone. Although praised by addiction experts as a tool to wean addicts off opioids, some are fearful the drug is being overprescribed and misused.

report by the Substance Abuse and Mental Health Services Administration (SAMHSA)  found a ten-fold increase in the number of emergency room visits involving buprenorphine. Over half of the hospitalizations were for non-medical use of buprenorphine – with some users taking the drug to get high.

The Center for Substance Abuse Research (CESAR) at the University of Maryland has warned of an epidemic of buprenorphine misuse emerging across the U.S. Researchers say addicts were smuggling buprenorphine into jails and the drug’s street value was growing because it doesn’t show up in drug tests.

“The true magnitude and scope of buprenorphine diversion, misuse, and adverse consequences is unknown because current epidemiologic measures do not systematically monitor buprenorphine,” CESAR warned in a December, 2012 newsletter. “Similarly, buprenorphine-related deaths are not accurately tracked because medical examiners and coroners do not routinely test for the drug.”

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