New Study Highlights Monthly SUBLOCADE® as a Potential Treatment Option for Opioid Use Disorder During and After Pregnancy

Rhea-AI Summary

Indivior PLC (INDV) announced a groundbreaking study on SUBLOCADE®, their monthly buprenorphine depot injection for treating opioid use disorder (OUD) during pregnancy. The study, published in the American Journal on Addictions, analyzed data from three sources: clinical case studies of four pregnant patients, five-year postmarketing surveillance data covering 322 pregnancy exposures, and a targeted literature review. Key findings showed no increased risk of birth defects, miscarriage, or maternal complications compared to general population rates. All four patients in the clinical case studies delivered healthy, full-term infants with normal birthweight and no neonatal opioid withdrawal syndrome. This research is particularly significant as opioid use during pregnancy increased 131% between 2010-2017, with pregnancy-related overdose deaths involving fentanyl rising from 5.73 to 9.47 per 100,000 from 2017-2020.

Positive

• Study demonstrates SUBLOCADE's safety profile during pregnancy with no increased risks
• All four clinical case study patients delivered healthy full-term infants
• Live births showed no reported birth defects in majority of known cases
• Research addresses critical knowledge gap in treating pregnant OUD patients

Negative

• Limited data with only 21% of pregnancies reporting outcomes in postmarketing surveillance
• Small patient cohort of only four cases in clinical case studies
• Study was funded by Indivior, potentially introducing bias

Insights

Addiction Medicine Specialist

SUBLOCADE shows promising preliminary safety data for pregnant women with OUD, potentially addressing a critical treatment gap during high-risk periods.

This retrospective study provides initial evidence regarding SUBLOCADE's safety profile during pregnancy and postpartum periods. The data amalgamates 322 pregnancy exposures from three sources: clinical case studies (4 patients), postmarketing surveillance spanning over five years, and literature review. The four documented clinical cases all resulted in full-term deliveries with normal birthweight, no fetal anomalies, and no neonatal opioid withdrawal syndrome requiring treatment.

The findings address a significant healthcare challenge, as opioid use during pregnancy has increased 131% from 2010-2017. More concerning is the sharp rise in pregnancy-associated overdose deaths involving synthetic opioids, which jumped from 5.73 to 9.47 deaths per 100,000 between 2017-2020, with most fatalities occurring post-delivery when healthcare engagement typically decreases.

While the monthly injection format could potentially improve medication adherence during vulnerable periods, this study has substantial limitations. The clinical case series is extremely small, and outcome data was available for only 21% of pregnancies in the postmarketing surveillance. This preliminary evidence suggests consistency with buprenorphine's established safety profile but falls short of providing definitive safety guidance.

The postpartum period represents a particularly high-risk window when treatment adherence often declines while overdose risk increases. A monthly formulation might offer advantages over daily medications during this critical transition, though comparative studies would be needed to confirm this hypothesis.

For clinicians, these findings support patient-centered decision-making and consideration of SUBLOCADE among treatment options, particularly when medication adherence is a concern. However, this retrospective, company-funded research requires validation through larger, prospective studies before drawing stronger conclusions about its role in managing OUD during pregnancy.

Pharmaceutical Industry Analyst

SUBLOCADE safety data in pregnancy expands potential market in critical high-need population amid rising maternal opioid overdose deaths.

This publication represents a potentially significant development for Indivior's SUBLOCADE by addressing a critical knowledge gap regarding its use during pregnancy and postpartum. With mental health and substance use disorders identified as the leading cause of pregnancy-related deaths in 36 states, and synthetic opioid overdose deaths increasing dramatically in the postpartum period, this study targets a growing unmet clinical need.

The retrospective data compilation suggests no increased risk of adverse outcomes compared to general population rates, positioning SUBLOCADE as a consideration for a vulnerable patient segment with limited treatment options. While preliminary, these findings could gradually influence treatment guidelines and prescribing patterns for pregnant women with OUD – a population experiencing a 131% increase in opioid use-related diagnoses at delivery over seven years.

From a commercial perspective, SUBLOCADE's monthly administration format offers a potential solution to the critical issue of medication adherence, particularly during the postpartum period when healthcare engagement typically decreases while overdose risk rises. This differentiating feature versus daily medications could be meaningful for both patients and providers.

However, investors should recognize the study's limitations. The clinical case series included just four patients, and outcome data was available for only 21% of pregnancies in the postmarketing surveillance. As company-funded research, these findings represent an early step rather than definitive evidence that would immediately alter prescribing behaviors.

Nevertheless, this publication in a peer-reviewed journal establishes credible preliminary evidence that could eventually support broader adoption in a high-risk population segment, potentially expanding SUBLOCADE's clinical utility and market reach. The focus on patient-centered decision-making aligns with current healthcare trends toward personalized treatment approaches.

SUBLOCADE use during pregnancy showed no increased risk of birth defects, miscarriage, or maternal complications compared to general population rates

RICHMOND, Va., May 1, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq/LSE: INDV) today announced the publication of a study "Monthly Buprenorphine Depot Injection (SUBLOCADE) for Opioid Use Disorder During Pregnancy" in the American Journal on Addictions, evaluating the use of SUBLOCADE for the treatment of opioid use disorder (OUD) during pregnancy and postpartum. Three sources of data evaluated in this retrospective study illustrated that the use of monthly SUBLOCADE during pregnancy demonstrated no increased risk and is consistent with the established buprenorphine safety profile.¹

This retrospective study includes clinical case studies from four pregnant patients treated with monthly SUBLOCADE, postmarketing surveillance data covering more than five years, and a targeted literature review. In total, 322 reports of pregnancy exposures to SUBLOCADE were identified. Of the four patients included in the clinical practice case studies, all delivered full-term infants with normal birthweight, no fetal anomalies, and no need for 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."

Between 2010 and 2017, opioid use during pregnancy dramatically increased, with a 131% increase in opioid use-related diagnoses at delivery in the U.S.² The U.S. national maternal morbidity and mortality data reveal mental health and substance use disorders are the leading underlying cause of pregnancy-related deaths in 36 states. While pregnancy-associated overdose deaths have been steadily rising since 2007, those involving fentanyl and other synthetic opioids markedly increased from 5.73 to 9.47 deaths per 100,000 in a span of just 3 years (2017–2020), with most deaths occurring post-delivery.³ This study helps address the current knowledge gap with relevant experience from patients and prescribers who used monthly SUBLOCADE during pregnancy and/or postpartum.

In addition to the case studies, the postmarketing surveillance data showed live births with no reported birth defects in the majority of known cases and rates of spontaneous abortion and other outcomes consistent with or lower than general population rates. Review of relevant literature also aligned with the findings from postmarketing and clinical data sources. These data highlight buprenorphine's established safety profile and offers practical insights into clinical care.

"OUD patients who are pregnant run the risk of experiencing a number of negative health consequences, such as infection, overdose, severe maternal morbidity, postpartum readmission, and even death, and using opioids during pregnancy has been linked to poor results for both the fetus and the newborn," said Christian Heidbreder, Chief Scientific Officer at Indivior. "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."

Treatment decisions during pregnancy and postpartum should reflect a shared decision-making approach between providers and patients, aligning with clinical guidance and product labeling. The patient-centered model is especially critical when managing chronic conditions, like OUD, in the perinatal period. These data support consideration of using SUBLOCADE as part of evidence-based treatment options, which include offering or continuing perinatal medications for OUD, prioritizing patient stability when considering a change of existing pharmacotherapy in pregnancy and postpartum, and assessing the benefits and risks in a patient-centered framework.

This is the largest amount of data available regarding the experience of pregnant patients on SUBLOCADE. Limitations of the study include limited descriptive data for case studies obtained from a small patient cohort and 21% of pregnancies reported outcomes for postmarketing surveillance.

Disclosure:
This work was funded by Indivior Inc., with the exception of the case studies and the time and contributions of Melinda Ramage, which were not supported by Indivior.

About SUBLOCADE®
SUBLOCADE ® (buprenorphine extended-release) injection, for subcutaneous use, CIII
 
INDICATION AND HIGHLIGHTED SAFETY INFORMATION
INDICATION
SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.

SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support.

HIGHLIGHTED SAFETY INFORMATION
WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION;
SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY

• Serious harm or death could result if administered intravenously.  SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life-threatening pulmonary emboli, if administered intravenously.
• Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program call the SUBLOCADE REMS Program.   Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements.

CONTRAINDICATIONS
Hypersensitivity to buprenorphine or any other ingredients in SUBLOCADE.

WARNINGS AND PRECAUTIONS
Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors.
Respiratory Depression: Life threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBLOCADE.
Risk of Serious Injection Site Reactions: Likelihood of may increase with inadvertent intramuscular or intradermal administration. Evaluate and treat as appropriate. The most common injection site reactions are pain, erythema and pruritus with some involving abscess, ulceration and necrosis.
Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy.
Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.
Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately.
Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during treatment.
Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patients have tolerated transmucosal buprenorphine before injecting SUBLOCADE.
Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect.

ADVERSE REACTIONS
Adverse reactions commonly associated with SUBLOCADE (in ≥5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain.

For more information about SUBLOCADE, the full Prescribing information including BOXED WARNING, and Medication Guide, visit www.sublocade.com.

About Opioid Use Disorder (OUD)
Opioid Use Disorder (OUD) is a chronic disease in which people develop a pattern of using opioids that can lead to negative consequences. OUD may affect the parts of the brain that are necessary for life-sustaining functions.

About Indivior
Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.

References:

1. Ramage M, Bishop B, Mangano V, Mankabady B. Monthly Buprenorphine Depot Injection (SUBLOCADE®) for Opioid Use Disorder During Pregnancy. Am J Addict. 2025.
2. Hirai AH, Ko JY, Owens PL, Stocks C, Patrick SW. Neonatal abstinence syndrome and maternal opioid-related diagnoses in the US, 2010–2017. JAMA. 2021; 325(2): 146-155. doi:10.1001/jama.2020.24991
3. Bruzelius E, Martins SS. US trends in drug overdose mortality among pregnant and postpartum persons, 2017–2020. JAMA. 2022; 328(21): 2159-2161. doi:10.1001/jama.2022.17045

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SOURCE Indivior PLC

FAQ

What are the main findings of INDV's SUBLOCADE pregnancy study?

The study found that SUBLOCADE showed no increased risk of birth defects, miscarriage, or maternal complications compared to general population rates. All four clinical case study patients delivered healthy full-term infants with normal birthweight.

How many pregnancy cases were evaluated in INDV's SUBLOCADE study?

The study evaluated 322 pregnancy exposures through postmarketing surveillance data over five years, plus four detailed clinical case studies.

What are the limitations of INDV's SUBLOCADE pregnancy study?

The study's limitations include a small clinical case study cohort of only four patients and limited data, with only 21% of pregnancies reporting outcomes in postmarketing surveillance.

Why is INDV's SUBLOCADE pregnancy study significant for the healthcare industry?

The study is significant because opioid use during pregnancy increased 131% between 2010-2017, and pregnancy-related overdose deaths are rising. This research provides important data about treatment options for pregnant women with opioid use disorder.

What was the outcome for babies born to mothers using SUBLOCADE in the clinical case studies?

All four babies were delivered full-term with normal birthweight, showed no fetal anomalies, and did not require treatment for neonatal opioid withdrawal syndrome (NOWS).