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Food and Drug Administration (FDA) approves Cassipa®: a new dosage strength sublingual film of buprenorphine and naloxone for maintenance treatment of opioid dependence

By: Maria Spilios, PharmD Candidate c/o 2019

Opioid dependence is a major public health concern. Misuse of prescription opioids and heroin affects more than two million Americans and an estimated fifteen million people worldwide per year; the prevalence of misuse and addiction is rapidly increasing with each passing year. More than 20,000 deaths in the United States were caused by an overdose of prescription opioids in 2017 and another 13,000 deaths were a result of heroin overdose. According to Dr. Robert Anderson, PhD, chief of the Centers for Disease Control and Prevention mortality statistics branch, “Drug overdoses are now the leading cause of death in U.S. adults under age 50, and opioids account for more than half of all drug overdose deaths.”1

Opioids are a class of drugs that act on the nervous system to produce feelings of pleasure and pain relief.1 They work as mu-opioid receptor antagonists to inhibit ascending pain pathways. The causes of opioid dependence and addiction are complex and vary from patient to patient. The condition results from a combination of genetic, environmental, and lifestyle factors and treatment of patients with acute and chronic pain not attributed to cancer or end-of-life conditions is a challenge for many clinicians. Evidence-based guidelines on duration of therapy postoperatively and in acute care settings is lacking. Over the last two decades, the over prescribing of opioids has resulted in many unintended consequences, including dependence and abuse.2 In terms of genetic factors, the mu-opioid receptor is produced from the OPRM1 gene and variations in this gene appear to influence how the body responds to opioids, including the amount of opioid needed to achieve pain relief. FDA Commissioner Scott Gottlieb, M.D. stated, “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”.3

On September 7, 2018, the Food and Drug Administration (FDA) approved Cassipa® (buprenorphine and naloxone) sublingual film. This film provides a new dosage strength – 16 milligrams/4 milligrams – in hope of promoting wider use and understanding of medication assisted treatment for opioid use disorder. Medication-assisted treatment (MAT) is an approach that combines FDA-approved medications, which currently include methadone, buprenorphine, and naltrexone, with behavioral therapies to treat opioid use disorder.3 At appropriate doses, buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids while simultaneously decreasing the pleasurable effects of other opioids. Buprenorphine works by binding to mu opioid receptors in the central nervous system with high affinity and is a partial mu agonist. Naloxone is a pure opioid antagonist that competes with and displaces opioids at the opioid receptor sites. Using these two drugs in combination allows for a slow, decreasing titration of opioids which is aided by weaning down with buprenorphine and naloxone in the event that the patient does take an opioid during the titration process. According to the Substance Abuse and Mental Health Services Administration, patients receiving MAT for treatment of their opioid use disorder cut their risk of death from all causes in half.3

Cassipa® was approved through an abbreviated approval pathway, relying on the FDA’s finding that a previously approved drug is safe and effective.3 In this case, the previously approved drug included multiple strengths of Suboxone®. Cassipa® should be used as part of a complete treatment plan along with psychosocial support and counseling after patient induction and stabilization. Adverse effects commonly seen with buprenorphine and naloxone sublingual films are oral hypoesthesia, glossodynia, nausea, vomiting, constipation, oral mucosa erythema, and hyperhidrosis. Pharmacists should counsel their patients on how to identify these adverse effects and can provide supportive care, if needed, in order to help an individual patient combat the opioid epidemic. Signs and symptoms of withdrawal may also occur with medications such as buprenorphine and naltrexone and as a result, only Drug Addiction Treatment Act (DATA) certified prescribers may prescribe these products to ensure they are used safely. The FDA will continue to evaluate additional therapies that can be beneficial in treating opioid use disorder and addressing the national crisis of opioid addiction.


  1. Genetics Home Reference. Available at: https://ghr.nlm.nih.gov/condition/opioid-addiction#statistics. Accessed 10/11/2018.
  2. Alexander LM, Keahey D, Dixon K. Opioid use disorder: A public health emergency. JAAPA. 2018;31(10):47-52.
  3. U.S. Food and Drug Administration. FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence. Updated 9/7/2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619864.htm. Accessed: 9/30/18.
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