A randomized clinical trial found that weekly extended-release buprenorphine achieved significantly higher illicit opioid abstinence during pregnancy compared to daily sublingual doses.
A National Institutes of Health (NIH)-funded, multisite, randomized clinical trial has found that a weekly extended-release formulation of buprenorphine (BRIXADI; Braeburn) is significantly more effective than traditional sublingual buprenorphine at maintaining illicit opioid abstinence in pregnant women.1,2 The study, known as the "Medication treatment for Opioid-dependent expecting Mothers" (MOMs) trial (NCTNCT03918850), was published in JAMA Internal Medicine and represents a landmark evaluation of long-acting injectable treatments in this population.1-3
Opioid use disorder (OUD) remains a formidable public health challenge in the United States, affecting approximately 2% to 3% of pregnancies, or roughly 1 in 40, according to national Medicaid claims data.1,2 Although sublingual buprenorphine is an evidence-based standard of care, it carries disadvantages related to daily adherence and potential medication diversion.¹ Extended-release formulations like BRIXADI (buprenorphine) may address these limitations by providing steady medication levels via subcutaneous injection.²
The open-label, noninferiority trial was conducted between July 2, 2020, and October 30, 2024, across 13 outpatient peripartum OUD treatment sites in the United States.1,2 A total of 140 participants with OUD and a singleton pregnancy between 6 and 30 weeks’ gestational age were randomized to receive either weekly extended-release buprenorphine (n = 69) or sublingual buprenorphine (n = 71). The mean (SD) age of participants was 31.2 (4.6) years, and the cohort was predominantly White (82.9%), with 7.1% Black and 7.1% Hispanic participants.
The primary outcome was the proportion of weekly urine samples negative for illicit opioids during pregnancy. The study not only met the margin for noninferiority but also demonstrated statistical superiority for the injectable formulation.
Abstinence rates from illicit opioids during pregnancy were 82.5% in the extended-release group compared to 72.6% in the sublingual group (mean difference, 9.84 percentage points; 95% CI, 1.72 to 17.95; P = 0.009). During the 12-month postpartum period, abstinence rates declined in both arms and were similar, at 60.2% and 59.5%, respectively (mean difference, 0.65 percentage points; 98% CI, −12.72 to 14.02; P = 0.45).
"Pregnant and postpartum individuals with opioid use disorder face enormous challenges," said John Winhusen, PhD, principal investigator, lead author, and professor at the University of Cincinnati College of Medicine, in a news release. "The trial results support the use of weekly extended-release buprenorphine for treating pregnant individuals with opioid use disorder."²
Maternal safety findings indicated that those receiving the weekly injection experienced fewer serious adverse events.1,2 During pregnancy, serious adverse event rates were 8.7% for the extended-release group versus 26.8% for the sublingual group (P = 0.007). In the postpartum period, these rates were 6.0% and 18.6%, respectively (P = 0.04). While the overall rate of nonserious adverse events did not differ, medication-related nonserious events were more frequent in the extended-release group during pregnancy (26.1% vs 7.0%; P = 0.003).
Infant outcomes showed no significant differences regarding neonatal opioid withdrawal syndrome (NOWS). Opioid treatment for NOWS was required by 30.2% of infants exposed to extended-release buprenorphine compared to 26.5% of those exposed to the sublingual version (relative risk, 1.14; 98% CI, 0.54 to 1.99; P = 0.64).¹ The mean (SE) number of treatment days for NOWS was 10.9 (2.2) days in the extended-release group and 14.8 (3.0) days in the sublingual group (relative risk, 0.73; 98% CI, 0.36 to 1.51; P = 0.28). At birth, neonates in the extended-release group had a larger mean (SE) head circumference (34.0 [0.2] vs 33.4 [0.2] cm; mean difference, 0.63 cm; P = 0.049).
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