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Abuse-Deterrent Formulations Save Lives

abuse deterrence blog post quoteThis guest blog post is written by Dan Cohen. Dan is the Forum Chair of the Abuse Deterrent Coalition. For more information, go to www.abusedeterrent.org.

As we near the end of 2015, it is obvious that the prescription drug crisis identified by the White House in 2011 has gotten even more desperate and requires urgent action. An estimated 16,000 lives are lost each year due to prescription opioid abuse. That’s 46 mothers, fathers, sisters and brothers lost every single day of the year.

Prescription drug abuse is a complex issue that requires multiple approaches to treat. While there are many solid efforts underway to combat Rx drug abuse through law enforcement, patient and physician education, rehabilitation, and regulation, the rapid growth of the problem demands a broader approach to solutions.

Technological approaches that reduce the likelihood of drug abuse are not yet widely adopted, and this has to change. The growing field of Abuse Deterrent Formulations (ADFs) offers new and meaningful approaches to help fight this epidemic. Current ADF technology limits the abuser from crushing, snorting and/or injecting powerful painkillers that would otherwise be preferred for an immediate high. If the industry continues to invest in this technology, the possibilities are limitless.

In April, the FDA issued new guidelines for the manufacture of abuse deterrence in opioids, believing that opioids formulated with abuse-deterrent properties are a public health priority. Since then, the FDA Advisory Committee on Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committee unanimously voted to support approval of Collegium Pharmaceutical’s Xtampza ER. Around the same time, Egalet Pharmaceutical’s Oxaydo IR went into commercial sales in the U.S. Both of these products included effective abuse-deterrent technologies.

This signal hopefully implies that the FDA may require all future Schedule II drugs to feature an ADF. Such a requirement is absolutely essential to help make prescription pain medication safer. Widespread adoption of ADFs is a critical element in the fight against prescription drug abuse, and it must be mandatory in all opioids and stimulants that have a high abuse potential.

Currently, 31 states are considering legislation requiring drugs to have ADFs — but state-by-state solutions for drugs sold across the country will not effectively curb this national crisis. We need to think bigger. To incentivize and ensure that pharmaceutical companies produce abuse-deterrent drugs, Congress must introduce and adopt federal legislation requiring the FDA to mandate such features in all Schedule II drugs. Mandatory legislation that clearly protects patient access to needed therapies, while making it harder for abusers to misuse today’s medications, will provide the necessary incentives for manufacturers to continue to research, develop and — most critically — deploy more abuse-deterrent technologies as part of the solution to the prescription drug abuse crisis in this nation.

The Abuse Deterrent Coalition was created to serve as a forum through which abuse-deterrent formulation technology manufacturers, patient and issue-advocacy associations, and pharmaceutical companies can educate the public, policy makers and the FDA on the importance of ADF technologies. The coalition provides a unified voice for legislative and regulatory initiatives that support the required use of abuse-deterrent formulations. We are making progress, but a comprehensive approach is needed to combat prescription pain medication abuse while still maintaining access for pain patients who need them. ADFs are a valuable tool in that effort — but only if the FDA and Congress require that this technology be used. Please take a look at the Abuse Deterrent Coalition website and help spread our mission to save lives. 

Interested in Learning More? Attend the 2nd Human Abuse Liability & Abuse-Deterrent Formulations Summit.

Dan Cohen will join a speaking faculty of more than 20 experts representing Cara Therapeutics, Egalet, Janssen, Kempharm, Pfizer, Reckitt Benckiser, Teva, Upsher-Smith, and many other organizations at the 2nd Human Abuse Liability & Abuse-Deterrent Formulations conference. Taking place November 2-3 in Bethesda, MD, this is the largest and most specifically focused drug industry event about the clinical and preclinical approaches necessary to reduce prescription drug abuse potential and thus improve regulatory compliance and market success. Register now to attend or view the program brochure for more information.

 

posted in Preclinical/R&D, Regulatory Affairs
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