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Reducing Risk with Abuse‑Deterrent Formulations

Excerpted from Pharmaceutical Technology's editorial titled, "Reducing Risk with Abuse‑Deterrent Formulations."

Increasing prevalence of drug misuse and abuse is driving a heightened and more stringent approach to abuse-deterrent formulations.

Possibly the most publicized and well-documented form of drug misuse and abuse has been that of opioids—prescription pain-relief medicines. The opioid crisis, which has impacted the global health community for several years, has paved the way for increased demand in abuse-deterrent formulations.

Abuse-deterrent formulations essentially have the potential to provide an effective way of reducing the capabilities of an end-user to abuse or misuse a medical therapy, while maintaining the drug’s clinical benefit. To explore the topic of abuse-deterrent formulations in more detail, Pharmaceutical Technology spoke with Angela Moore, scientist, Analytical Development, Alcami.

Topics: News & Events Abuse-Deterrence Editorials Blogs

eBook: Analytical Testing in Drug Development

Alcami recently contributed to an eBook produced by Drug Development and Delivery. The eBook, titled "Analytical Testing in Drug Development," features four companies and explains how they each help the pharmaceutical and biotech industries comply with drug development regulatory requirements. 

Angela Moore, abuse-deterrence studies subject matter expert at Alcami, contributed to the eBook. Her article focuses on considerations for abuse-deterrent Category 1 studies as well as standard syringeability studies.

Topics: Regulatory Compliance Abuse-Deterrence Editorials Development

Editorial: Overcoming the Opioid Overdose Crisis

Alcami recently contributed to an article in the Greater Wilmington Business Journal titled, "Overcoming the Opioid Overdose Crisis."

Our community has come together, like many others, to combat the opioid crisis. Several local agencies have rallied to create impactful community resources. A 2016 survey by Castlight, which listed Wilmington, NC as the #1 city for opioid abuse in the United States, was a wake-up call to the level of severity this community has been affected by opioid-related fatalities and hardships. At Alcami, we work with our clients to develop abuse deterrence medicines to help combat this nationwide epidemic that hits home, even here in Wilmington.

Topics: Abuse-Deterrence Editorials

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: Abuse-Deterrence Blogs

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: Abuse-Deterrence Editorials

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: News & Events 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: Abuse-Deterrence Analytical Development Blogs

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: Abuse-Deterrence Editorials

Overview and Performance of the Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics

Several agencies within the U.S. Federal government are focused on reducing the prescription drug crisis the country is experiencing. How significant is the crisis?

Over the course of a given year, approximately 100 million people in the United States suffer from pain. An estimated 9 to 12 million have chronic or persistent pain, while the remainder have short-term pain from injuries, illnesses, or medical procedures.1 Education and treatment of pain management, specifically the impact of opioid drug prescription use, continues to challenge the medical community. 

Since 1999, the quantity of prescription opioids sold in the United States has nearly quadrupled, resulting in an average of 650,000 opioid prescriptions dispensed daily. Deaths from prescription opioids—drugs like oxycodone, hydrocodone, and methadone—have also quadrupled, causing more than 165,000 deaths in the United States within a 15-year time period (1999–2014). Additionally, an estimated 1.9 million people in the United States suffer from substance-use disorders related to prescription opioid pain medicines.2

Topics: Abuse-Deterrence Blogs