FDA Approves New Dosage Strength of Buprenorphine and Naloxone Sublingual Film for Opioid Dependence Treatment

Officials with the FDA have approved a new dosage strength (16 milligrams/4 milligrams) of buprenorphine and naloxone sublingual film (Cassipa, Teva Pharmaceuticals) for the maintenance treatment of opioid dependence. The combination also is approved by the agency for both brand name and generic versions, and in various strengths.

In a prepared statement, FDA Commissioner Scott Gottlieb, MD, said the agency recently described a streamlined approach to drug development for certain medication-assisted treatments that are based on buprenorphine. This approach can reduce drug development costs, so products may be offered at a lower price to patients and we can broaden access to treatment, he added.

“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 Gottlieb, in the prepared statement. “The FDA is committed to helping those with opioid use disorder transition to lives of sobriety. 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.”

According to Gottlieb, individuals who successfully transition onto medication-assisted treatment are not swapping 1 addiction for another. Rather, he said, the prepared statement, 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,”” Gottlieb added.

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 (OUD). 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. At proper doses, buprenorphine also decreases the pleasurable effects of other opioids, making continued opioid abuse less attractive. According to the Substance Abuse and Mental Health Services Administration, patients receiving MAT for treatment of their OUD cut their risk of death from all causes in half.

Cassipa was approved through an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act, called the 505(b)(2) pathway. A new drug application submitted through this pathway may rely on the FDA’s finding that a previously approved drug is safe and effective or on published literature to support the safety and/or effectiveness of the proposed product, if such reliance is scientifically justified.

According to the FDA, 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 milligrams of buprenorphine using another marketed product.

Adverse events commonly observed with the buprenorphine and naloxone sublingual film are oral numbness, burning mouth, inflammation of oral mucous membrane, headache, nausea, vomiting, excessive sweating, constipation, signs and symptoms of withdrawal, insomnia, pain and accumulation of fluid causing swelling in lower limbs.

These products may only be prescribed by Drug Addiction Treatment Act-certified prescribers.

Visit this link to learn how pharmacists can play a greater role in addressing the opioid crisis.

Reference

FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence [news release]. Silver Spring, MD; September 7, 2018. FDA website. http://www.pharmacytimes.com/link/217. Accessed September 8, 2018.