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The guidance discusses acceptable clinical endpoints for demonstrating effectiveness of drugs developed to treat opioid use disorder.
FDA published guidance on October 1, 2020 directed at sponsors developing drugs to treat opioid use disorder (OUD). The guidance discusses acceptable clinical endpoints for demonstrating effectiveness of OUD treatments but does not address the development of drugs that only provide relief of opioid withdrawal symptoms.
Specifically, the guidance encourages the evaluation of the reduction of adverse outcomes related to OUD such as mortality, need for emergency medical interventions, and hepatitis C infection. The guidance also discusses other endpoints such as change in disease status using diagnostic criteria for OUD, change in drug use pattern, and patient-reported outcomes.
The guidance also stresses the importance of benefit-risk considerations. “If a product is associated with a risk of serious adverse events, more compelling demonstrations of clinical benefit may be needed to outweigh this risk. If the product itself has abuse potential, FDA will consider the positive and negative public health effects of the drug, including risk of diversion, the drug’s potential effect on risks to both patients and nonpatients, such as members of the patient’s household (e.g., children, teenagers, visitors, and others). The risks considered include those related to misuse, abuse, OUD, overdose, and accidental exposures, particularly in children,” FDA states in the guidance.