U.S. FDA approves Orexo drug to treat opioid addiction

July 4 Thu Jul 4, 2013 10:45am EDT

July 4 (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 drug, Zubsolv, is a tablet that dissolves under the tongue. It combines the drugs buprenorphine and naloxone and will compete with similar products, Subutex and Suboxone, made by British's Reckitt-Benckiser Group Plc.

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

In March, the FDA rejected a similar drug 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 .

Orexo said it expects to launch the drug in the U.S. around September. It said on Monday it had signed a deal with contract sales organization Publicis Touchpoint Solutions under which both companies would share in the investment and profit.

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 7.75 kronor, or 11.74 percent, to 73.75 in midmorning trading on the Stockholm Stock Exchange. Earlier they rose as high as 75.50.

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