FAQ

The Abuse Deterrent Coalition was created as a “talk forum” of Abuse Deterrent Formulation Technology Manufacturers, Patient & Issue Associations and Pharmaceutical Manufacturers to educate the public, policy makers and the FDA on the importance of ADF technologies in the fight against prescription drug abuse. Furthermore, the coalition provides a unified voice for legislative and regulatory initiatives that support the required use of abuse deterrent formulations for drugs that have high potential for abuse.

Abuse deterrent formulations for prescription drug products are designed to make manipulation more difficult or less rewarding.

While there are a variety of ADF approaches, there are three main methods for abuse deterrence in use or under nearer-term development that address different manners of abuse:

  1. Physico-chemical barriers (crush/chewing resistance, gelling)
    • Specific ingredients and manufacturing technology make otherwise identical tablets resistant against crushing or breaking as a barrier for abuse through snorting and to an extent by chewing. When attempting to dissolve the drug for injection, these formulations turn into a gel-like mass which makes it very difficult or close to impossible to get the drug through the needle of a typical syringe. This barrier is in the “new” OxyContin and other products.
  2. Pharmacological barriers (opioid agonist/antagonist approach)
    • Opioids work by attaching themselves to receptors in the body. By embedding other drugs -- so-called antagonists -- into the pill, the effect of the narcotic can be blocked when abused (e.g. when crushing or dissolving), while still releasing the appropriate medication when used as prescribed by the patient. This barrier is in the hydromorphone product recently approved by the FDA, Hysingla.
  3. Pro-drugs
    • Pro-drugs are products that release the active drug in the body after swallowing, typically in the digestive tract. For example, when the pill reachs the intestines, enzymes in the gut cause the release of the active ingredient as prescribed and designed. It helps prevent the rapid euphoria that abusers seek. Only one pro-drug of amphetamine is in the market which demonstrates lower rates of abuse compared to the traditional amphetamine products, stimulant products, but abuse by oral and non-oral routes is still possible.

Lastly, combinations of these, and other technologies offer the potential to increase the effectiveness of ADF inclusion in different products. Current abuse deterrent products have reduced abuse for snorting, injecting and chewing. Nothing has yet come to the market that reduces abuse by swallowing. No abuse deterrent technology provides 100% protection.

Schedule II drugs are defined by the Drug Enforcement Agency (DEA) as products with a high potential for abuse with use potentially leading to severe psychological or physical dependence. These drugs are considered dangerous. Download a full list of Schedule II drugs.

Schedule II drugs, by definition, are considered to have a high potential for abuse and misuse. Abuse of prescription drugs (both stimulants and pain medication) can be a gateway for further more dangerous drug use. Abuse deterrent formulations are designed to make pills more difficult to tamper with and they can impede the intense high that abusers and addicts seek through manipulating the medication.

Prescription pain medications such as opioids offer important treatment options for people with severe pain, often providing relief and allowing some to resume their daily activities. Unfortunately, these drugs can be misused, abused, or diverted to others for illicit use—problems that have become pervasive across the country. However, each year approximately 4.5 million Americans use prescription pain medications for non-medical purposes contributing to more than 16,000 deaths annually. Comprehensive approaches must combat the misuse and abuse of prescription pain medications while maintaining access for patients who need them. As one component of this overall strategy, new drug formulations offer promising deterrents against certain types of abuse.

For a full list of Abuse Deterrent Coalition members, please visit the home page.

A reformulated OxyContin® was the first opioid to contain an ADF when it was approved by the FDA in April 2013. In addition, the FDA has approved five additional opioids with ADF qualities: Suboxone®, Embeda®, Opana®, Exalgov®, and Zohydro ER®.

The FDA considers abuse-deterrent opioid formulations a priority and has issued a “Draft Guidance” policy for manufacturers seeking to develop such medications. In that policy, the FDA recognizes that abuse-deterrent opioid formulations represent one aspect of a desperately needed, comprehensive program to address prescription opioid misuse, abuse, and diversion. Still, the FDA draft guidance needs to be issued in final form for manufacturers to have greater confidence that the FDA will approve new ADF product formulations.

No. ADFs are designed to limit the ability of an individual to abuse a product, but no technology is perfect. Today ADF formulations limit the ability for abusers to crush, inject and/or snort products to get an immediate “high.” But oral abuse is still possible.

Since OxyContin® introduced an abuse deterrent version of its product, abuse of the drug dramatically declined. RADARS (Researched Abuse, Diversion and Addiction- Related Surveillance System) monitors the impact of abuse deterrent products on rates of prescription opioid abuse, misuse, overdose, death and diversion. The impact of the reformulation of Opana® Extended Release and OxyContin® was studied. The findings suggest that the introduction of opioid products reformulated to deter abuse corresponded with reductions in intentional abuse exposures by these products.

The Abuse Deterrent Coalition was created to serve as a forum of Abuse Deterrent Formulation Technology Manufacturers, Patient & Issue Associations and Pharmaceutical Manufacturers to educate the public, policy makers and the FDA on the importance of ADF technologies in the fight against prescription drug abuse. Furthermore, the coalition provides a unified voice for legislative and regulatory initiatives that support the required use of abuse deterrent formulations for prescription drugs that have a high potential for abuse.

Ask your doctor or pharmacist if the prescribed medication has ADF properties or label or if substituting your medication for an ADF version is appropriate.

OxyContin® and Opana® both did not raise the cost of their product when reintroduced with an ADF version. Future drugs will come to the market with ADF technology built into the cost of the drug's development.