ISSUE NO. 3 — Assessing Human Abuse Potential to Limit the Misuse and Abuse of Prescription Drugs — updated April 2022
Prescription drugs, including opioid analgesics, are an important component of modern pain management; however, along with their euphoric effects comes an increased possibility of misuse and abuse—all of which can lead to addiction, overdose, or death.
The FDA has undertaken many efforts to help clinicians manage this widespread issue by instating guidelines to better understand the abuse potential of new drugs, and ensure drugs currently on the market are less likely to be abused through the use of abuse-deterrent formulations (ADFs). The FDA guidance, Assessment of Abuse Potential of Drugs, states that a broad range of CNS drugs require human abuse potential (HAP) studies, also known as human abuse liability (HAL) studies, to evaluate the abuse liability of drugs in development, and to determine the relative risk of abuse before a drug comes to market.
In Issue 3 of The Altascientist, we look at the intricacies and key considerations involved in conducting these sensitive HAP studies, including:
- FDA’s steps to limit the misuse and abuse of prescription drugs
- human abuse potential study solutions
- study design and protocol
- a case study
Human Abuse Potential Study Designs
HAP studies are clinical pharmacology studies and play a key role in the overall abuse potential assessment of a new chemical entity (NCE). As per the FDA’s guidance, Altasciences’ HAP
Psychedelics are gaining interest for treating psychiatric illnesses. Altasciences’ experts can guide a clinical development strategy to evaluate safety, pharmacokinetics, and pharmacodynamics. With a team recognized in pharmacology, addiction, and regulatory services, we can help build your target product profile and clinical development plan, ensuring comprehensive studies and data early to support regulatory milestones and FDA meetings.
Abuse potential evaluation is also required to evaluate novel formulations designed to specifically reduce or deter abuse of a drug. According to the National Center for Drug Abuse Statistics, 16 million, or 6% of Americans over the age of 12, abuse prescription drugs every year. In addition, many individuals misuse their prescription medications by tampering with the formulation. The FDA has worked to address this problem by encouraging the development of abuse-deterrent formulations (ADFs) for opioids and other drugs that are associated with a high risk of abuse.
These products are formulated with properties expected to meaningfully deter certain types of abuse and/or make abuse more difficult or less rewarding. This allows patients who are in chronic pain to have appropriate access to drugs, such as opioid analgesics, with significantly less risk of abuse through unintended routes, such as intranasal insufflation or injection.
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