Abuse Deterrent Program
Prescription opioid abuse epidemic
Non medical use of prescription opioids in USA has increased over threefold since 1990 to epidemic proportion.1 Approximately 100 million adults in the United States experience pain that can affect performance on daily tasks, quality of life, and productivity in the workplace2.Approximately 4.5 million individuals use prescription pain medications for nonmedical purposes3.
The rate of opioid overdoses has tripled since 20004. In 2014, rates of opioid overdose deaths increased significantly, from 7.9 per 100,000 in 2013 to 9.0 per 100,000 – a 14% increase5. In the same year, prescription opioids were involved in almost 19,000 deaths6.
Routes of opioid abuse
Opioids can be abused and misused in a variety of ways. For example, an abuser may swallow a greater quantity of the unaltered drug than what is prescribed. This typically occurs with extended-release opioids. Also, abusers may crush extended-release opioids and ingest the drug in a number of ways, including: Swallowing, Snorting, Smoking or Dissolving and injecting7.
Abuse Deterrent opioid formulations
Abuse-deterrent opioids are formulated to deter abuse and misuse of the drug. The goal of abuse-deterrent opioids is to limit access to or attractiveness of the active ingredient that is highly attractive to abusers, while still assuring the safe and effective release of the medication for patients7.
The FDA guidance provides that abuse-deterrent formulations are categorized into one of the following groups: Physical/Chemical barriers, Agonist/Antagonist combinations, Aversion, Delivery system, new molecular entities and Prodrug, Combination and Novel approaches7.
SPARC has developed an abuse deterrent technology that has ability to deter the most common route of abuse - oral ingestion of multiple pills. It is designed to deliver clinically effective dose if used as prescribed. Upon ingestion of multiple pills the technology reduces and delays the release of drug, thereby resulting in lower peak plasma concentration. The technology also has ability to tailor the number of pills beyond which release inhibition is desired.
Additionally, the technology can also deter drug abuse by snorting or injecting and can prevent the drug extraction by common solvents.
Non medical use of prescription opioids in USA has increased over threefold since 1990 to epidemic proportion. Approximately 100 million adults in the United States experience pain that can affect performance on daily tasks, quality of life, and productivity in the workplace.Approximately 4.5 million individuals use prescription pain medications for non-medical purposes.