This report summarizes the input shared by individuals with OUD, caregivers, and other stakeholders during the meeting or through the webcast. It also includes a summary of comments submitted to the public docket. To the extent possible, the terms used in this report to describe specific health effects, impacts, treatment experiences, and perspectives reflect the words used by in-person participants, web participants, or docket commenters. The report is not meant to be representative in any way of the views and experiences of any specific group of individuals or entities. There may be health effects, impacts, treatments, or other aspects of OUD not included in this report.
The input from the meeting and docket comments underscore the diversity in experiences with OUD, the complexity of selecting an appropriate treatment, and the broader challenges individuals with OUD face in accessing care and support. Several key themes emerged from this meeting:
• OUD is a chronic, neurobiological disease with devastating impacts. Participants reiterated both the acute and chronic health effects of OUD, which sometimes last decades into their recovery. Participants described “being a prisoner” to opioid withdrawals often accompanied by nausea, vomiting, and uncontrollable muscle spasms. Participants also offered insight on opioid “cravings,” or desire to use. They highlighted the relationship between craving and anxiety and stressed that cravings are more than a physical liking for a substance. Cravings were described as “the act of doing it, preparing it, consuming it, the immediate relief afterwards.” Participants also stressed that cravings may last well beyond acute withdrawal and can be triggered unpredictably. Other long-term effects included scarring due to IV drug use, insomnia, anxiety, and fear.
• OUD affects all aspects of individuals’ lives. Participants described significant impact on their work and ability to care for themselves and family. Many participants described the devastating loss of meaningful relationships with family and friends due to their OUD. Some participants commented that mending relationships with family and friends was often a key motivator for their journey to recovery. Participants also expressed their worries of relapse in the future.
• Participants emphasized that effective management of OUD requires a holistic approach tailored to the needs of the individual. They expressed varying perspectives on the desired outcomes of treatment, ranging from complete abstinence from opioid use to better managing or controlling use of opioids. The shared focus, however, was to improve their functioning, wellbeing, and safety. Participants also expressed mixed views on the role of MAT in their journey. Some participants said that they accept the need to stay on MAT for the long term. Some, however, hope to “detox off MAT” once they have stabilized in recovery. And some participants said they do not see a role for the currently available MAT in their recovery.
• Participants identified several challenges and barriers to accessing and sustaining MAT. They highlighted the impact of stigma on their interactions with healthcare providers and others, particularly when being perceived as “an addict” or when being labeled as “dirty” or “clean.” Participants also highlighted challenges in access to MAT, including long wait times, difficulty finding facilities that provide MAT, strict requirements for entry into MAT programs, medication cost, and concerns about safety at the facility. They described the added challenges to maintaining recovery due to the intensity of withdrawal and craving, the significant pain or mental health needs, and their own difficulty in coming to terms with their illness.
• More broadly, participants stressed the need for greater awareness of OUD and understanding of their needs as a community. Participants offered insights on how to better help individuals with OUD manage their condition, including working toward development of non-opioid treatment options, integrating MAT into primary care, and implementing holistic approaches that integrate mental health, social support, and medical treatment. Most importantly, participants stressed the need to reduce the stigma of OUD, help individuals create “situations of stability”, and to not lose sight of their underlying pain, trauma, or mental health needs.
The patient input generated through this PFDD meeting and the public docket comments strengthens FDA’s understanding of the impact of OUD on individuals and the treatments currently used to manage OUD. FDA staff will carefully consider this input during the drug development process, including when advising sponsors on their drug development programs and when assessing products under review for marketing approval. This input may also be of value to the drug development process more broadly. For example, it may be useful to drug developers as they explore treatments more specific to symptoms of OUD, or in designing interventions that can facilitate enhanced management of OUD.
U.S. Food and Drug Administration (FDA)
Disease Category: Tobacco, drugs, & alcohol dependence
Disease Name: Opioid use disorder
Age Range: Unknown
Sex:
Nature of Intervention:
- Patient perspectives