Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Abuse Deterrent Formulation: The new approach to reduce prescription drug abuse in the United States ***

Dr. Fatima Bicane (Abschlußjahr: 2013)

Summary

Language: English

Prescription drug abuse is a significant public health issue in the United States, and drug overdose death rates have risen steadily over the last 10 years. To address this issue the FDA announced in 2009 that manufacturers dealing with high-potency opioids would be required to implement risk evaluation and mitigation strategies. Developing abuse deterrent formulations (ADF) is one measure to achieve this goal. Two main formulation approaches can be distinguished to minimize the risk of drug abuse: The physical approach is based on incorporation of a physical barrier that makes the dosage form resistant to crushing, impeding the key step in most forms of non-oral opioid abuse. The chemical approach uses the incorporation of an aversive stimulus intended to create an unpleasant effect if the drug product is tampered with prior to ingestion. Co-formulation with a sequestered opioid-antagonist that is released upon tampering is a further effective chemical approach.

The development of such ADF formulations presents several challenges to the pharmaceutical companies from a technological, pharmaceutical, clinical, and regulatory perspective. So far relevant guidance on the subject is hardly available since only a draft of the FDA exists leading to a low predictability of the success of a development program.

This Master Thesis summarizes historical and current approaches to abuse deterrence and analyses the challenges for companies and recent decisions by regulatory bodies. The draft Guidance of the FDA is presented and critical remarks are given. Suggestions for improvements are made, as it is conceivable that ADFs can be helpful to overall efforts to reduce prescription drug abuse and can play a valuable role in broad scale programs focused on achieving such reductions.

Pages: 44