FDA Approves New Dosage Strength of Sublingual Film for Opioid Dependence

On Sept. 7, 2018, FDA approved Teva Pharmaceutical’s Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid dependence. 

The approval provides a new dosage strength (16 mg/4mg) of buprenorphine and naloxone sublingual film, which is also approved in both brand name and generic versions and in various strengths, FDA reports.

Medication-assisted treatment (MAT) is a comprehensive approach that combines FDA-approved medications (currently methadone, buprenorphine, or naltrexone) with counseling and other behavioral therapies to treat patients with opioid use disorder. According to the agency, regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse. When administered in the proper doses, buprenorphine also decreases the pleasurable effects of other opioids, making continued opioid abuse less attractive.

In August 2018, the FDA issued draft guidance, Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment,outlining new ways for drug developers to consider measuring and demonstrating the effectiveness and benefits of new or existing MAT products, building on another draft guidance, Opioid Dependence: Developing Depot Buprenorphine Products for Treatment, issued in April 2018 outlining the agency’s current thinking about drug development and trial design issues relevant to the study of depot buprenorphine products (i.e., modified-release products for injection or implantation). In June 2018, the agency also approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film in multiple strengths.

FDA states that Cassipa should be used as part of a complete treatment plan that includes counseling and psychosocial support and should only be used after patient induction and stabilization up to a dose of 16 mg of buprenorphine using another marketed product.

“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,” said FDA Commissioner Scott Gottlieb, MD, in an agency press release. “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.”

Source: FDA