Cassipa, a Teva Phaarmaceuticals manufactured sublingual film containing naloxone and buprenorphine in new dosage amounts, receives FDA approval on the 7^th of September as a continuing therapy for opioid addiction.

In a press release, the FDA announced that the buprenorphine and naloxone sublingual film, formulated in a 16 mg/4 mg dose for Cassipa, is sanctioned not only in its brand version but also in its generic edition. The two drugs in different strength combinations are also approved by the FDA.

A set management protocol including psychotherapy and counseling should comprise of Cassipa post the patient is administered and stabilized with a step-ladder buprenorphine 16 mg dose of another brand. Drug Addiction Treatment Act (DATA) certified professionals only can prescribe these drugs.

“There’s an urgent need to ensure access to, and wider use and understanding of, medication-assisted treatment for opioid use disorder ... 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, MD, mentioned in the statement.

Adding that, “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.”

Opioid use disorder patients are recommended to be treated with Medication-assisted treatment (MAT), a methodical way amalgamating counseling, psychotherapy and drug formulae approved by the FDA. 

Suboxone sublingual film’s safety and efficacy testing by the FDA proved beneficial, partly, in getting approval for Cassipa via the abbreviated 505(b)(2) approval pathway.