BlogHeader.png

Considerations for Abuse-Deterrent Category One Syringeability Studies

The use of opioid medications for pain management continues to increase, generating an inevitable association with abuse and addiction. Government officials and pharmaceutical professionals alike are in need of risk mitigation approaches (Katz, 2008). The Abuse Deterrent Access Act of 2018 requires Medicare and Medicaid to report to Congress the availability of abuse-deterrent opioid pain treatments. The bill is meant to decrease the amount of barriers for their enrollees (Carter, 2018).

The U.S. Department of Health and Human Services (HHS) has estimated that in 2016, the most recent year for which complete data are available, over 42,249 Americans died from opioid overdoses, the most of any year on record. More than 2.1 million Americans had an opioid use disorder (addiction) in 2016, with economic costs from the epidemic estimated to be as high as $504 billion dollars (Johns Hopkins University Bloomberg School of Public Health, 2018).” Pharmaceutical companies have responded to this need through more stringent abuse-deterrent formulations and studies.

Topics: Thought Leadership Abuse-Deterrence

Alcami Donation to Outfit TROSA Medical Department

Durham, NC (USA) – March 15, 2018 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, and Triangle Residential Options for Substance Abusers, Inc. (TROSA), a Durham-based innovative, multi-year residential program that enables substance abusers to be productive, recovering individuals by providing comprehensive treatment, work-based vocational training, education, and continuing care, today announce Alcami’s donation of $10,000 to the nonprofit. Alcami’s gift will fund TROSA’s technology needs for its recently established Comprehensive Care Center.

Topics: Company News Analytical Development Analytical Testing Abuse-Deterrence Alcami in Action Biologics

Editorial: Tackling the Opioid Crisis with Abuse-Deterrent Formulations

Alcami recently contributed to an article featured in Pharmaceutical Technology titled "Tackling the Opioid Crisis with Abuse-Deterrent Formulations." 

The United States is facing an opioid crisis. FDA has expressed concern about the growing epidemic of opioid abuse, dependence, and overdose, and part of its action plan includes a call to pharmaceutical manufacturers to develop opioid formulations with abuse-deterrent properties (1). As a result, there is increasing interest in the development of abuse-deterrent formulations as the technologies to prevent abuse among patients and recreational abusers continue to advance rapidly. 

Topics: Thought Leadership Editorials Abuse-Deterrence

Alcami Helps Fight Opioid Addiction Epidemic

Opioid addiction is a public health crisis impacting millions of individuals of all ages, from all backgrounds and walks of life. Drug overdoses are the leading cause of death in the United States[1]  and communities across the country are struggling to respond to the epidemic. Alcami is committed to combating addiction and fighting substance abuse through its ongoing abuse-deterrence program and is answering the national call for help by dedicating much-needed resources to local treatment, education and recovery services.

Topics: Company News Alcami in Action Thought Leadership Abuse-Deterrence

ON-DEMAND WEBINAR: Abuse-Deterrent Category One Testing: Syringeability Studies

As of July 2017, America’s opioid crisis has been declared a state of emergency. In order to help combat prescription opioid drug misuse and abuse, pharmaceutical drug companies are developing and commercializing drug products that have abuse- deterrent features. The FDA issued guidance in April 2015 for new drug applications (NDAs), and suggested guidance in March 2016 for generic abbreviated new drug applications (ANDAs) to aid in the formal evaluation of the abuse-deterrent nature of drug products. A crucial test for drug products that are abused intravenously are syringeability studies. Because most syringeability studies are performed exclusively in-vitro due to the hazardous nature of abuse-deterrent formulation excipients, accurate experimental design is crucial and carefully reviewed by the FDA.

Topics: Webinars Abuse-Deterrence

Abuse-Deterrent Studies – An Interview with Angela Moore

As one of the key contributors to current abuse-deterrent studies being performed in the Alcami laboratory and having over 11 years of experience performing analytical testing in the pharmaceutical industry, Angela Moore was the perfect scientist to meet up with for a conversation on abuse-deterrent studies.

Moore was drawn to the pharmaceutical industry by having the ability to be a behind the scenes collaborator working on getting new drugs developed and brought to the market. She thrives on learning new technologies and being part of a team that can help save people’s lives through medicines.

Thanks for stepping out of the lab to share your experiences with abuse-deterrent studies. First of all, how would you explain your work with abuse-deterrence to a family member, for instance?
Thanks for having me. Being able to share what my team does is a great way of showing how patients come first in our line of work. I would say to my family that I research how people misuse or abuse long-acting opioid drug products in real life. After researching how people abuse them, I develop methodical scientific ways to mimic the abuse in a laboratory setting to see if new drug products can resist the abuse. This testing is meant to ensure that any new opioid products that are available by prescription cannot be easily used to get high in the future.

Topics: Thought Leadership Abuse-Deterrence

Editorial: Fighting Prescription Drug Abuse with Demonstrated Abuse-Deterrent Formulations

As published in Pharma's Almanac Q3 2017.


As the number of opioid prescriptions in the US has climbed dramatically, so has the abuse and misuse of these drugs, leading to loss of life and significant social costs. The pharmaceutical industry, in conjunction with FDA, has focused on identifying approaches for the development of abuse-deterrent opioid formulations and methods for demonstrating their effectiveness. Choosing the right strategy for a given drug can be difficult. Partnering with a contract development and manufacturing organization (CDMO) that has experience with different abuse-deterrent opioid formulation methods and established expertise in the development of in vitro abuse-deterrent studies can accelerate approval.

Topics: Thought Leadership Abuse-Deterrence Editorials

Executive Brief: An Opioid Abuse-Deterrent Roadmap for the Pharmaceutical Industry

Since 1999, deaths from prescription opioids—drugs like oxycodone, hydrocodone, and methadone—have quadrupled, causing more than 165,000 deaths in the U.S. 

Topics: Resource Center Abuse-Deterrence

White Paper: Abuse-Deterrent Studies for Controlled Drugs - A Changing Landscape

Alcami has recently authored a white paper regarding the changing landscape in abuse-deterrent studies for controlled drugs. 

  • Governmental and regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and Department of Health and Human Services (HHS), have made significant investments towards the reduction of the misuse of prescription drugs.

    Engineering abuse-deterrent properties into prescription forms of drugs with abuse potential has become a primary strategy for abuse prevention.

Topics: Resource Center Abuse-Deterrence

ON-DEMAND WEBINAR: Demonstrate Abuse-Deterrent Properties in Opioid Formulations

Prescription opioid abuse has reached epidemic levels in the United States, with nearly 20,000 deaths in 2014 (the most recent year for which statistics are available) from unintentional overdose of prescription opioids and nearly 36,000 deaths in which prescription opioids were either directly or indirectly implicated. This issue has become a major regulatory focus over the last several years and has resulted in the issuance of FDA guidances requiring abuse-deterrent properties for new opioid drug formulation NDA’s (final guidance April 2015) and generic ANDA’s (draft guidance May 2016). A major component of proving the abuse-deterrent properties for a new formulation is the execution of in vitro manipulation and extraction studies, which companies are increasingly turning to CRO’s to perform.

Topics: Webinars Abuse-Deterrence