The US Food and Drug Administration (FDA) has approved new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence.
FDA approval
With this announcement, Cassipa (buprenorphine and naloxone) sublingual film is available in a new dosage strength (16 milligrams/4 milligrams) and both brand name and generic versions are approved.
“There’s an urgent need to ensure access to, and wider use and understanding of, medication-assisted treatment for opioid use disorder,” said FDA Commissioner Dr Scott Gottlieb. “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.
“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.”
Cassipa was approved through an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act, called the 505(b)(2) pathway. This approval was granted to Teva Pharmaceuticals USA. It should be used as part of a complete treatment plan that includes counselling and psychosocial support and should only be used after patient induction and stabilisation up to a dose of 16 mg of buprenorphine using another marketed product.