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Opioid-Dependence Drug Zubsolv (Buprenorphine/Naloxone) Set for U.S. Launch

Sublingual tablets approved in July (September 5)

The Swedish drug-maker Orexo has announced that Zubsolv (buprenorphine and naloxone) sublingual tablets (CIII) will be available in U.S. pharmacies from September 16. The product received FDA approval in July 2013 for the maintenance treatment of opioid dependence as part of a complete treatment plan, including counseling and psychosocial support.

According to Orexo, Zubsolv will be reimbursed in more than 70% of the current market for opioid replacement therapy. The drug will be launched with list-pricing comparable with that of Suboxone (buprenorphine and naloxone, Reckitt Benckiser) sublingual film, but with co-pay support initiatives.

Zubsolv sublingual tablets reportedly deliver more buprenorphine to the bloodstream, allowing patients to use a lower dose and thereby reducing the amount of available drug for potential misuse and diversion. The naloxone component of Zubsolv further reduces the potential for intravenous misuse and diversion.

The tablets, however, can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient’s level of stability is essential.

Adverse events commonly observed with the sublingual administration of buprenorphine/naloxone sublingual tablets during clinical trials and post-marketing experience include headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.

Source: Orexo; September 5, 2013.

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