Orexo Wins FDA Approval for Zubsolv for Opioid Dependence

Andrew Klips  |

Swedish drugmaker Orexo AB (ORXOF) reported Friday that the U.S. Food and Drug Administration approved Zubsolv (buprenorphine and naloxone), a once-daily sublingual tablet for the maintenance treatment of opioid dependence. Orexo says that the drug, which eases withdrawal symptoms, should be used as part of a complete treatment plan, including counseling and psychosocial support.

Zubsolv will be direct competition to Reckitt Benckiser Group Plc's Suboxone and Subutex. Reckitt dominates the market, but lost patent protection on the two drugs in their original form in 2009. Since, Reckitt has successfully brought to market Suboxone Film, a strip that dissolves under the tongue.

Orexo says that Zubsolv will give physicians and patients a new choice with better bioavailability, faster dissolve time, smaller tablet size and a menthol flavor.

Titan Phamaceuticals was hoping to enter the space with Probuphine, a long-lasting version of Suboxome implanted under the skin to treat opioid addition, but the drug failed to gain FDA approval in April. In a complete response letter, the FDA requested additional information from Titan on several points, including the effect of higher doses of Probuphine and training on insertion and removal of the implant.

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Opioid dependence has been a hot topic a discussion at the FDA in 2013, encouraging manufacturers to utilize technologies that help deter abuse, amid growing pressures on the agency to limit opioid use. On Tuesday, Acura Pharmaceuticals (ACUR) reported that Pfizer, Inc. (PFE) is expanding its commercialization efforts of Oxectar (oxycodone HCl) tablets that employ Acura's Aversion technology to prevent abuse of the opioid by keeping it from being crushed. Abusers will pulverize painkillers like oxycodone, hydrocodone and codeine for snorting or injecting.

According to Orexo, about five million Americans are affected by opioid dependence, costing the economy about $56 billion annually and resulting in nearly 17,000 deaths each year. For a decade now, opioid-related deaths annually have outpaced the number of deaths resulting from heroin and cocaine overdoses.

"The advanced formulation of Zubsolv was developed using our proprietary technology to meet the needs of patients not satisfied with previously approved buprenorphine/naloxone formulations," said Robert DeLuca, President, Orexo U.S., Inc.

Zubsolv's better bioavailability than Suboxone equates to less drug being required and, thus, lower drug amounts for potential misuse.

Orexo expects to launch the Zubsolv sometime around September and thinks sales can peak around $500 million for the drug.

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