Swedes win U.S. approval

The Swedish drug company Orexo has won approval of a drug for treating opioid dependence in the U.S.
Foto: Orexo AB/ PR
Foto: Orexo AB/ PR
by Martin Havtorn Petersen

U.S. authorities, FDA, has approved the drug Zubsolv from Swedish pharma outfit, Orexo AB, the Swedes reveal in a press release.

Zubsolv, an oral drug consisting of the substances buprenorphine and naloxone, has been approved for the treatment of patients suffering from dependence of opioids, such as codeine or methadone.

The drug is not the first of its kind on the American market, but unlike rival drugs the Swedes stress that their pill is smaller, dissolves easier and comes with a fresh menthol taste.

New treatment option

“Orexo has developed Zubsolv as a novel sublingual therapy meeting the needs of millions of patients [who suffer] from opioid dependence to offer them a new choice of treatment,” says Nikolaj Sørensen, President and CEO of Orexo AB, in the press release and adds:

“Zubsolv has in previous studies [shown] a high acceptability compared to the leading treatment modalities in the market. We expect Zubsolv will be well received by patients and prescribers and we anticipate a peak market potential of at least $500M.”

The CEO also explains that Zubsolv will be the company’s third marketed product in the U.S. when it is launched in the country in September. The technology relating to this latest product in Orexo’s portfolio will be patent protected on a number of markets worldwide. Projected expiry dates for this IP range from 2019 to 2032, the company reveals.

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