The FDA has approved the marketing of buprenorphine in sublingual tablets (Reckitt Benckiser) both alone (Subutex) and with naloxone (Suboxone) for treatment of opioid dependence. Previously available only for parenteral use in treatment of pain (Buprenex, and others), it offers an alternative to methadone (Dolophine, and others), which is now often abused (New York Times, February 9, 2003; page 1). As a schedule III narcotic, buprenorphine will be subject to fewer prescribing restrictions than a schedule II drug such as methadone (MJ Kreek and FJ Vocci, J Subst Abuse Treat 2002;...

Methadone, an opioid agonist that can be taken orally, has been used for maintenance treatment for many years in the USA (DM Novick et al, Drug Alcohol Depend, 33:235, 1993). Last year, the US Food and Drug Administration approved the distribution and use of L-alpha-acetyl-methadol (LAAM; ORLAAM - Bio Development Corporation, McLean, VA), a long-acting congener of methadone. LAAM, like methadone, will be available for this indication only through federal and state-regulated treatment programs.

Pharmacologic management of opioid withdrawal symptoms can reduce the intensity of drug craving and improve treatment retention in patients with opioid use disorder who will receive maintenance treatment. Withdrawal management without subsequent maintenance treatment is associated with high rates of relapse, overdose death, and HIV and/or hepatitis C virus infection. Several guidelines on management of opioid withdrawal are available. Maintenance treatment of opioid use disorder was reviewed in a previous issue.

Opioid use disorder is a chronic, relapsing disease with physical and psychiatric components. It is associated with economic hardship, social isolation, incarceration, increased rates of blood-borne infections such as HIV and viral hepatitis, adverse pregnancy outcomes, and increased mortality. According to the NIH, there were 80,411 deaths involving an opioid in the US in 2021, more than in any previous year. Several guidelines on the management of opioid use disorder are available; all recommend maintenance pharmacotherapy as the standard of care.

View Expanded Table: Some Drugs for Management of Opioid Withdrawal Symptoms

The FDA has approved subdermal implants of the partial opioid agonist buprenorphine (Probuphine – Titan) for maintenance treatment of opioid dependence in patients stabilized on low to moderate doses of transmucosal buprenorphine. Probuphine was designed to provide continuous low levels of buprenorphine for 6 months and to safeguard against illicit use of the drug.

View Comparison Table: Some Drugs for Maintenance Treatment of Opioid Use Disorder

The FDA has approved a buccal film formulation of the partial opioid agonist buprenorphine combined with the opioid antagonist naloxone (Bunavail – BioDelivery Sciences) for maintenance treatment of opioid dependence. Sublingual tablet and film formulations of the same combination were approved earlier. The manufacturer of Bunavail claims that the new product is superior to sublingual formulations because of the convenience of buccal administration and better absorption into the blood, permitting use of lower doses.

A new CDC guideline for prescribing opioids for pain recently became available. Nonopioid drugs for pain were reviewed in a previous issue.

The FDA has approved use of lubiprostone (Amitiza) for treatment of opioid-induced constipation in adults with chronic non-cancer pain. The drug was previously approved for chronic idiopathic constipation and irritable bowel syndrome with constipation.