In this 3-part series, I share a few thoughts about the benefits and limitations of medication-assisted treatment (MAT) for the moderate to severe opioid use disorder (OUD). In Part 1, I provide a brief introduction to the topic.
Approximately 2.1 million people suffer from OUD, a chronic relapsing illness characterized by repeated, compulsive opioid seeking or use despite harm. The most recent data on fatalities from the opioid overdose crisis (MMWR, January 4, 2019) report an average of 130 deaths each day from opioid overdose in 2017, representing a 12% increase from the previous year. The “silver lining” in the otherwise somber news was the stabilization of deaths from prescription opioids and heroin. Synthetic opioids, primarily illicitly manufactured fentanyl and its analogs were responsible for the upsurge, accounting for 60% of fatalities, an increase of about 45% from the previous year. The devastation would likely be far greater, absent significant congressional appropriations, intervention by various HHS operating divisions, including NIDA, SAMHSA and FDA, and the involvement of other stakeholders at the federal, state and local level.
Efforts by HHS have included: (i) NIDA’s growing emphasis on funding high impact OUD and opioid overdose research directed at FDA approval of putative treatments; (ii) the NIH HEAL Initiative to address the opioid crisis via more effective and safe ways to prevent and treat OUD; (iii) SAMHSA’s robust focus on expanded access by linking individuals with OUD to harm-reduction services; (iv) FDA Division of Anesthesia, Analgesia, and Addiction Products (DAAAP) timely approval of Opiant/Adapt’s intranasal naloxone, an opioid overdose reversal agent (NARCAN®); and (v) DAAAP’s approval of MATs, including the recently introduced monthly extended-release (depot) subcutaneous buprenorphine (Sublocade™) from Indivior and the “tentative approval” for Braeburn’s depot buprenorphine (Brixadi™).
Medication-Assisted Treatment (MAT)
The standard of care for moderate to severe OUD is MAT combined with counseling and psychosocial support. The objectives of MAT are to reduce or eliminate illicit opioid use (by decreasing cravings and withdrawal symptoms), criminal activity, and the spread of infectious diseases, while improving function and quality of life. Pharmacologic interventions assume a far greater role than counseling because medications have a much better evidence base than counseling, and publicly-funded treatments generally do not pay for frequent counseling.
Three FDA-approved medications are available for MAT: (i) daily oral and monthly IM depot naltrexone; (ii) daily oral methadone; and (iii) daily oromucosal (subcutaneous and buccal) and monthly subcutaneous depot buprenorphine. The benefits and shortcomings of available MATs relate to their pharmacologic effects, diversion risk, prescribing restrictions and routes of administration. Despite their important contribution to the field of addiction medicine, the overall success of MATs in achieving abstinence from illicit opioids is modest, particularly for naltrexone.
In part 1 of a 3 part post, I share a few thoughts about the benefits and limitations of oral and oromucosal medication-assisted treatment (MAT) for the moderate to severe opioid use disorder (OUD).
Dr. Najib Babul, PharmD, MBA.