There are a number of brand name and generic versions of buprenorphine and naloxone therapies that are delivered via a sublingual film. Teva’s product contains 16 milligrams of buprenorphine and 4 milligrams of naloxone, bringing a new dosage strength to the market.
“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 Dr. Scott Gottlieb said in prepared remarks.
“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 added.
The FDA noted that Cassipa should be used as part of a plan that also includes counseling and psychosocial support. The U.S. regulatory agency also said that the product should be used after a patient has been stabilized up to a dose of 16 milligrams of buprenorphine using another marketed product.
Adverse events linked to Teva’s buprenorphine and naloxone film include oral numbness, a burning sensation in the mouth, inflammation of the oral mucous membrane and headache.