FDA Approves New Dosage Strength for Buprenorphine and Naloxone Film Therapy

September 8, 2018
Kevin Kunzmann

The sublingual film therapy has been approved under a 16 mg/ 4 mg dosage strength for the maintenance treatment of opioid dependence, adding to therapy options which include both brand name and generic versions.

The US Food and Drug Administration (FDA) has approved buprenorphine and naloxone (Cassipa) sublingual film therapy for the maintenance treatment of opioid dependence.

The treatment, indicated for application under the tongue, has been approved under a new dosage strength (16 mg/ 4 mg) of the buprenorphine and naloxone film—adding to therapy options which include both brand name and generic versions in multiple dosage strengths.

Buprenorphine and naloxone 16 mg/4 mg was approved under the 505(b)(2) pathway—an abbreviated regulatory process which may rely on the FDA’s finding that a previously approved therapy is beneficial and safe—following its approval in other dosage strengths.

As a medication-assisted treatment (MAT), the therapy joins other FDA-approved medications—methadone, buprenorphine, naltrexone—as a combining treatment for patients with opioid use disorder (OUD) who also receive counseling and other behavioral therapies. According to the FDA, MAT adherence plus buprenorphine reduces symptoms of OUD withdrawal without adding to the cyclical “highs” and “lows” associated with opioid abuse.

Buprenorphine has also been found to decrease the pleasurable effects of opioids. Patients with OUD receiving MAT therapy cut their risk of death from all causes in half, according to the Substance Abuse and Mental Health Services Administration.

There is currently an urgent need to provide more access to, and provide more education of, MAT for OUD, FDA commissioner Scott Gottlieb, MD, said in a statement. Introducing more treatment options only adds to the potential that in-need patients will gain access.

“We’ve taken a number of steps to advance the development of new FDA-approved treatments for opioid dependence and encourage health care professionals to ensure patients are offered an adequate chance to benefit from these therapies,” Gottlieb said. “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.”

Gottlieb said that, contrary to popular belief, individuals transitioning onto MAT are not “swapping one addiction for another.”

“Opioid replacement therapy can be an important part of effective treatment,” Gottlieb said. “Opioid use disorder should be viewed similarly to any other chronic condition that is treated with medication.”

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