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FDA approves Teva’s Cassipa for treatment of opioid dependence

The Food and Drug Administration has given the nod to Teva’s Cassipa (buprenorphine and naloxone) sublingual film, or applied under the tongue, for the maintenance treatment of opioid dependence. This action provides a new dosage strength (16 ml/4 ml) of buprenorphine and naloxone sublingual film, which also is approved in both brand name and generic versions, as well as in various strengths.

“There’s an urgent need to ensure access to, and wider use and understanding of, medication-assisted treatment for opioid use disorder. The introduction of new treatment options has the potential to broaden access for patients. For example, the FDA recently described a streamlined approach to drug development for certain medication-assisted treatments that are based on buprenorphine. This streamlined approach can reduce drug development costs, so products may be offered at a lower price to patients, and we can broaden access to treatment,” FDA commissioner Scott Gottlieb said.

Gottlieb also said that the FDA is committed to helping those with opioid use disorder transition to lives of sobriety.

“We’ve taken a number of steps to advance the development of new FDA-approved treatments for opioid dependence and encourage healthcare professionals to ensure patients are offered an adequate chance to benefit from these therapies. We’re also working to address the unfortunate stigma that’s sometimes associated with the use of opioid replacement therapy as one approach to the successful treatment of addiction. Despite what some may think, individuals who successfully transition onto medication-assisted treatment are not swapping one addiction for another. Opioid replacement therapy can be an important part of effective treatment. Opioid use disorder should be viewed similarly to any other chronic condition that is treated with medication,” Gottlieb said in a statement.

In June, the FDA approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film in multiple strengths.
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