FDA approves new formulation for addiction drug

FDA approves new opioid-addiction drug
FDA approves new opioid-addiction drug

The FDA has approved a new sublingual tablet formulation of the opioid-addiction drug buprenorphine-naloxone (Zubsolv), according to the drug's manufacturer, Orexo.

The once-daily tablet is indicated for maintenance treatment against opioid dependence in combination with a treatment plan that includes counseling and pyschological support, the drug maker said in a press release.

The medication is a partial-agonist of opioid receptors -- buprenorphine is an opioid agonist while naloxone is an opioid antagonist. During clinical trials, the most common adverse effects were headache, nausea, vomiting, hyperhidrosis, constipation and insomnia, as well as withdrawal symptoms.

Opioid addiction is a growing problem in the United States, affecting 5 million people. Only about 1 million of those affected seek treatment, and approximately 17,000 people die from opioid-related causes annually.

The FDA approval is the latest development in the increasingly competitive market of opioid-addiction medications. The agency approved generic sublingual tablets of buprenorphine-naloxone (Suboxone, Reckitt-Benckiser) in February. In 2010, the manufacturer replaced the tablet formulation of Suboxone with a sublingual film version.

Orexo said Zubsolv has greater bioavailability, smaller size and a menthol flavor in response to patient complaints that Suboxone has a bitter taste and takes too long to dissolve.

“The approval of Zubsolv provides a new treatment option that offers unique advantages specifically designed to meet the unmet needs expressed by patients and has the potential to improve patient adherence, thereby reducing relapse rates and improving successful patient outcomes," Louis E. Baxter, Sr., MD, FASAM, former president of the American Society of Addiction Medicine said in statement.

Patient liver function should be determined prior to treatment with Zubsolv and monitored throughout the duration of treatment, Orexo said. The medication should be stored away from children, as it can cause severe and potentially fatal respiratory depression in this age group.

by Walker Harrison, an undergraduate student at Columbia University and editorial intern with Clinical Advisor.

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