A new retrospective study published in the American Journal on Addictions suggests that monthly buprenorphine depot injection (SUBLOCADE) could be a safe and effective treatment option for pregnant patients with opioid use disorder (OUD). The research, announced by Indivior PLC on May 1, 2025, found no increased risk of birth defects, miscarriage, or maternal complications compared to general population rates.
The study represents the largest collection of data available regarding pregnant patients treated with SUBLOCADE, examining three distinct data sources: clinical case studies from four pregnant patients, postmarketing surveillance data spanning more than five years, and a targeted literature review. In total, researchers identified 322 reports of pregnancy exposures to the medication.
Clinical Outcomes and Safety Profile
All four patients included in the clinical practice case studies delivered full-term infants with normal birthweight. Notably, no fetal anomalies were reported, and none of the newborns required treatment for neonatal opioid withdrawal syndrome (NOWS).
"The findings shared in this manuscript support perinatal, patient-centered decision-making," said Melinda Ramage, FNP-BC, CARN-AP, LCAS, Director of the North Carolina Perinatal Substance Use Disorder Network and lead author of the publication. "Treatment is not one-size-fits-all, and it is important to explore safe and effective options for the mother–baby dyad."
The postmarketing surveillance data revealed live births with no reported birth defects in the majority of known cases. Rates of spontaneous abortion and other outcomes were consistent with or lower than general population rates, aligning with buprenorphine's established safety profile.
Addressing a Growing Public Health Crisis
The research addresses a critical need as opioid use during pregnancy has dramatically increased in recent years. Between 2010 and 2017, there was a 131% increase in opioid use-related diagnoses at delivery in the United States.
Dr. Baher Mankabady, Senior Vice President at Indivior, emphasized the severity of the situation in a recent interview: "Substance use disorder is now the leading cause of death in the US, and it tripled since 2007."
U.S. national maternal morbidity and mortality data reveal that mental health and substance use disorders are the leading underlying cause of pregnancy-related deaths in 36 states. Pregnancy-associated overdose deaths have been steadily rising since 2007, with those involving fentanyl and other synthetic opioids markedly increasing from 5.73 to 9.47 deaths per 100,000 between 2017 and 2020. Most of these deaths occur post-delivery.
Benefits of Long-Acting Formulation
As a partial opioid agonist, buprenorphine has been established as a safe and effective treatment for OUD for over 20 years. The monthly injectable formulation offers potential advantages over daily oral medications.
"Buprenorphine is not only safe and efficacious, but also improves adherence, reduces rediversion, misuse, abuse and maintains persistent therapeutic range for patients," Dr. Mankabady explained.
Christian Heidbreder, Chief Scientific Officer at Indivior, highlighted the broader implications: "As public health professionals and policymakers look for ways to reduce maternal overdose deaths, this study offers important new information about how long-acting medications like SUBLOCADE might be incorporated into a broader strategy to increase access and enhance outcomes for families affected by OUD."
Patient-Centered Approach to Treatment
The researchers emphasize that treatment decisions during pregnancy and postpartum should reflect a shared decision-making approach between providers and patients, aligning with clinical guidance and product labeling. This patient-centered model is especially critical when managing chronic conditions like OUD in the perinatal period.
"Pregnancy is a unique, motivating time. When patients with OUD get pregnant, this is the time that they will be open for treatment and engagement with healthcare providers," noted Dr. Mankabady. "This study offers promising evidence that SUBLOCADE can be safely considered during treatment of OUD during pregnancy."
Expanding Access to Treatment
To improve outcomes for pregnant patients with OUD, Dr. Mankabady recommends three key steps: eliminating stigma and misinformation that discourage providers from treating pregnant individuals with OUD, updating medical guidelines to reflect the use of long-acting formulations like SUBLOCADE, and expanding access to medication-assisted treatment, especially in OB-GYN and primary care settings.
While the study provides valuable insights, the researchers acknowledge limitations, including limited descriptive data for case studies obtained from a small patient cohort and the fact that only 21% of pregnancies reported outcomes for postmarketing surveillance.
The work was funded by Indivior Inc., with the exception of the case studies and the contributions of Melinda Ramage, which were not supported by the company.
SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine product or who are already being treated with buprenorphine. It should be used as part of a complete treatment plan that includes counseling and psychosocial support.
