Laboratory Services

Abuse Deterrence Studies

Laboratory Services
Specialty Capabilities

Enhancing Safety with FDA-Compliant Abuse Deterrence

The abuse of prescription medications is a critical issue in the United States and its neighboring countries. In an effort to control this epidemic, the FDA has updated its guidelines on opioid formulations to include strategies to reduce or eliminate the potential for abuse and misuse.

To evaluate how easily a product can be abused or compromised, the FDA now requires a scientifically rigorous laboratory-based in-vitro manipulation and extraction study to be performed. Your abuse-deterrent studies project will be in experienced hands here at Alcami.

  • Key Concepts of Abuse-Deterrence Studies

    Abuse-deterrence studies are essential in evaluating how a drug product can withstand various forms of physical manipulation, including both actual and speculative abuse techniques. These studies also focus on extractability and solubility, carefully analyzing the chemical properties of active ingredients and excipients to determine the potential for abuse. The selection of a valid comparator and the application of complex analytical methodologies are critical due to the diverse matrices encountered, making these studies challenging yet crucial for ensuring product safety.

  • Various types of physical manipulation, reflecting actual and speculative abuse techniques

  • Extractability and solubility studies designed around an understanding of the chemical characteristics of the active and excipient components

  • Determination of a valid comparator

  • Complex analytical methodology due to the wide variety of matrices encountered

  • Particle size characterization for drugs that may be crushed and inhaled, and evaluation of the ease/difficulty of pushing through a syringe for drugs that may be injected

  • Why Perform Abuse-Deterrence Studies?

    Performing abuse-deterrence studies is not only a regulatory requirement by the FDA and Health Canada for new opioid formulations but also a strategic advantage for pharmaceutical companies. These studies are crucial for NDA and ANDA filings, often placing products on the FDA fast track for priority approval. Additionally, they can reduce the scope and cost of subsequent studies, addressing a significant public health concern while offering a marketing edge over competitors.

  • Required by the FDA and Health Canada for new opioid formulations

  • Necessary for NDA filings

  • Necessary for ANDA filings for generic solid oral opioid drug products

  • Products with these studies are placed on the FDA fast track and often given priority approval

  • May reduce the scope (and cost) of subsequent pharmacokinetic and clinical studies

  • Politicians in the US have highlighted this issue as the nation’s fastest-growing drug problem and requested regulation supporting abuse-deterrence programs

  • Gain the marketing advantage over competitors making products with the propensity for abuse

  • Benefits of Working With Alcami on Your Next Abuse-Deterrence Study

    Partnering with Alcami for your abuse-deterrence studies ensures compliance with FDA guidelines, backed by a robust cGMP traceability system and a proven track record in successful NDA filings. Our expert team builds challenges into each study to anticipate and mitigate potential issues, providing flexible project management, a full range of complementary services, and access to extensive knowledge from previous programs. Alcami is committed to delivering reliable, high-quality outcomes tailored to your specific needs.

  • Experts performing abuse-deterrence studies per FDA guidelines

  • Full cGMP traceability

  • Experience building challenges into the study

  • Success in a number of studies used for NDA filings

  • Capability to perform preliminary studies to determine study conditions and minimize the chance of issues occurring throughout the study

  • Excellent reputation for responsiveness, problem-solving, and reliable outcomes

  • cGMP compliant with robust quality systems

  • Exemplary compliance record

  • Experienced project management team ensures scope and timeline are communicated and achieved

  • Flexibility to change the project scope when needed

  • Full range of complementary development and manufacturing services

  • Access to knowledge gained from long-term experience interpreting the general guidance across multiple programs – no two programs are the same

Summary

Alcami offers specialized abuse-deterrence testing services. Our expertise helps pharmaceutical companies comply with FDA regulations and develop opioid formulations resistant to abuse. Through rigorous laboratory testing and analysis, Alcami supports clients in bringing innovative and safer products to market.

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