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FDA approves Orexo drug to treat opioid addiction

By Toni Clarke

(Reuters) - The U.S. Food and Drug Administration has approved Swedish drugmaker Orexo AB's drug to treat opioid addiction, the company said on Thursday, sending its shares up as much as 14.3 percent in Stockholm.

The tablet, Zubsolv, dissolves under the tongue. It combines the drugs buprenorphine and naloxone and will compete with similar products, Subutex and Suboxone, made by Britain's Reckitt-Benckiser Group Plc.

Orexo said its drug offers a benefit to patients over Suboxone because less is required to achieve the same effect. It also has a menthol flavor that it said patients in a study preferred.

Nearly three out of four prescription drug overdoses are caused by painkillers known as opioids that include such drugs as oxycodone, hydrocodone, fentanyl, methadone and codeine, according to the Centers for Disease Control and Prevention, and since 2003 have caused more overdose deaths than cocaine and heroin combined.

In March, the FDA rejected a drug similar to Orexo's from Titan Pharmaceuticals Inc and asked for additional data proving it worked. Titan's drug, Probuphine, is a long-acting version of Suboxone that is implanted under the skin.

To date, the market for buprenorphine has been dominated by Reckitt, a consumer goods company whose products range from cleaning supplies to condoms. Suboxone and Subutex generated sales of roughly $1.3 billion in 2012.

Orexo said opioid dependence affects nearly 5 million people in the United States and that only 20 percent receive treatment. The company said it expects peak sales of the drug to be at least $500 million.

Suboxone and Subutex lost market exclusivity in 2009, and while generic competitors introduced cheap copies of Subutex, they were slow to develop alternatives to Suboxone. In the meantime, Reckitt persuaded many physicians to switch from Suboxone tablets to Suboxone Film, a newer, patent-protected wafer-like strip that patients dissolve under the tongue.

At the end of 2012, according to Reckitt, Suboxone Film had captured 64 percent of the market.

Earlier this year, the FDA approved generic versions of Suboxone tablets from Amneal Pharmaceuticals LLC and Actavis Inc.

The agency also said, in April, that it would not approve any generic versions of the original form of OxyContin, which could be crushed and snorted for a quick high. OxyContin's maker, Purdue Pharma LP, stopped shipping its branded version of the drug in August. It now sells a reformulated version that is less easy to abuse.

Orexo said it expects to launch the drug in the United States around September. It said on Monday it had signed an investment and profit-sharing deal with contract sales organization Publicis Touchpoint Solutions.

Once Publicis has recovered its investment and an agreed upon return, the amount of which was undisclosed, Publicis would receive a single digit share of the profit until the contract ends in December 2016.

Orexo's shares were up 8 kronor, or 12.12 percent, at 74.00 on the Stockholm Stock Exchange. Earlier they rose as high as 75.50.

(1.00 SEK = 0.149 USD)

(Reporting by Toni Clarke in Washington; Editing by Steve Orlofsky and Richard Chang)

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