In September 2018, the U.S. Food and Drug Administration approved Cassipa which is buprenorphine and naloxone in a sublingual film to be used for opiate maintenance treatment. The action provides a new dose of 16 mg of buprenorphine and 4 mg of naloxone, which is approved in both brand name and generic formulation and in differing strengths. It’s all part of the FDA’s new efforts to combat the nations opiate crisis and to save lives lost to opiate overdose.
FDA Commissioner Dr. Scott Gotlieb said, “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. 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.”
Why is MAT Successful for Opioid Maintenance Treatment?
Medication-assisted treatment is a comprehensive approach using FDA-approved medications (methadone, buprenorphine, or naltrexone), for opiate dependence treatment. Patients who regularly adhere to MAT with buprenorphine experience reduced withdrawal symptoms and a reduction in the desire to use opiates. At proper dosage, buprenorphine also decreases the euphoria associated with opiate abuse, which means continuing to abuse opiates isn’t as appealing to an addicted person. MAT works so well because with strict medical supervision, regular suboxone clinic visits and additional counseling, it reduces cravings and allows a person to become clean gradually without experiencing all the discomfort of withdrawal and detox.
The goal of approving a medication like Cassipa is to improve access to prevention, opioid maintenance treatment and recovery services, which includes offering a full range of MAT services. The Food and Drug Administration is working hard to reduce the scope of the opiate crisis and the draft guidance issued in August 2018, is just the beginning. Cassipa was approved through a shorter pathway covered under the Federal Food, Drug and Cosmetic Act, also known as the 505 (b)(2) pathway. The FDA remains committed to addressing the US opiate crisis on all fronts and is taking important steps to promote and improve MAT.