Orexo Wins U.S. Backing for Opioid-Addiction Tablet

Orexo AB (ORX), a Swedish specialty pharmaceutical company, won U.S. approval for a tablet to treat addiction to heroin and prescription painkillers.

The Food and Drug Administration cleared the drug known as Zubsolv for opioid dependence, the company said today in a statement. The tablet, which dissolves under the tongue, is the first competition to Reckitt Benckiser Group Plc (RB/)’s Suboxone.

Zubsolv combines buprenorphine and naloxone to ease withdrawal symptoms and block the high of opioids. Uppsala, Sweden-based Orexo, which specializes in reformulating drugs in sublingual form, estimates Zubsolv’s market potential to be at least $500 million in annual sales. The company generated about $48 million in revenue last year, according to data compiled by Bloomberg.

The FDA rejected a buprenorphine implant called Probuphine in April from Titan Pharmaceuticals Inc. (TTNP) The FDA asked for more data on the effect of higher doses of the medication and training for doctors on insertion and removal of the implant.

Buprenorphine and another treatment for opioid addiction, methadone, trick the brain into thinking it’s still getting opioids. Methadone users must be enrolled in a treatment program.

Prescription painkillers were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined, the Centers for Disease Control and Prevention said. More than five million U.S. citizens suffer from opioid dependence, Orexo said.

Fighting Abuse

Drugmakers are attempting to make prescription opioids harder to abuse by creating tamper-resistant formulations that deter tablet crushing that gives addicts a greater high. The FDA determined in April that generic-pharmaceutical companies couldn’t make copies of closely held Purdue Pharma LP’s OxyContin that don’t have tamper resistant qualities.

Reckitt’s Suboxone was first approved as a tablet in 2002. The London-based company discontinued the tablets, and focused on film version, after it said in September 2012 it found significantly higher rates of accidental pediatric exposure with the tablets. The Suboxone film was approved in August 2010.

Zubsolv, like Suboxone, will be wrapped in individual child-resistant packages, Orexo said.

Orexo said July 1 that it formed a partnership with Publicis Touchpoint Solutions, based in Yardley, Pennsylvania, to help sell Zubsolv in the U.S..

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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