The FDA commissioner noted that the approval will expand access for patients and reduce drug development costs.
The U.S. Food and Drug Administration (FDA) approved a new dosage strength for a maintenance drug for the treatment of opioid addiction.
Cassipa, which is a sublingual (applied under the tongue) film that combines the opioid treatment drug buprenorphine and the opioid overdose reversal drug naloxone, will now be available in a 16 milligrams/4 milligrams dosage, and according to FDA Commissioner Scott Gottlieb, should be used in conjunction with counseling and therapy.
The new dosage strength is approved by the FDA in both brand name and generic versions, and in various strengths.
The approval underscores the agency’s emphasis on greater development of and access to medication-assisted treatment (MAT) for substance use disorder. The full range of MAT is a key element of the U.S. Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis, and was the focus of guidelines issued to drug manufacturers for evaluating the effectiveness of new or existing MAT products.
In a statement issued in April 2018, Gottlieb described the FDA-approved MAT drugs—methadone, buprenorphine and naltrexone—as “safe and effective in combination with counseling and psychosocial support to stabilize brain chemistry [and] reduce or block the euphoric effects of opioids.”
The FDA has also cited statistics from the Substance Abuse and Mental Health Services Administration (SAMHSA), which found that patients using MAT for opioid dependency have reduced their chance of overdose death by half.
In addition to its suggested efficacy for opioid use disorder, Gottlieb noted that newer treatment options like the increased dosage strength for Cassipa will not only “broaden access for patients,” but may also “reduce drug development costs, so products may be offered at a lower price to patients” via the agency’s “streamlined approach to drug development for certain medication-assisted treatments that are based on buprenorphine.”
This approach is the abbreviated 505(b)(2) pathway under the Federal Food, Drug and Cosmetic Act, which allows manufacturers to use the FDA’s findings regarding the safety of their product to grant approval.
The FDA is advising that Cassipa should be used in conjunction with a complete treatment plan that includes counseling and other support, and should only be used after the patient is introduced to the drug and stabilized up to a dose of 16 mg of buprenorphine using another marketed product. Additionally, Cassipa can only be prescribed by Drug Addiction Treatment Act-certified prescribers.
