Prescription Drug Abuse

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Prescription Drug Abuse

Chronic pain is a widespread and growing problem for which many patients do not receive adequate treatment.  In many cases pain is undertreated due to concerns about abuse and tampering with currently available opioid formulations. Many opioids are diverted for abuse/misuse by a growing number of people including teenagers.

    • FDA estimates that more than 33 million Americans age 12 and older misused extended-release and long-acting opioids during 2007—up from 29 million just five years earlier.
    • And in 2006, nearly 50,000 emergency room visits were related to opioids.

The most recently available data from the National Survey on Drug Use and Health (2009) highlights the significant problems associated with prescription pain reliever abuse:

    • In 2009, an estimated 7.0 million (2.8%) people 12 years or older reported using pain relievers non-medically in the past month
    • From 2002 to 2009, there was an increase among young adults aged 18 to 25 in the rate of current non-medical use of prescription-type drugs (from 5.5 to 6.3%), driven primarily by an increase in pain reliever misuse (from 4.1 to 4.8 percent).
    • In 2009, the illicit drug categories with the largest number of past year initiates among persons aged 12 or older were marijuana use (2.4 million) and non-medical use of pain relievers (2.2 million).

Tampering/Misuse

Extended release formulations are attractive targets for non-medical abuse since they contain relatively large doses of the active drug. Although the drug is intended to be released over a prolonged period, abusers frequently destroy the time-release mechanism by chewing, crushing or dissolving the formulation in commonly available household beverages or solvents. Formulation “tampering” is reported to be widely prevalent. It has been suggested that as abuse progresses, many individuals shift from ingesting their medications orally to snorting then injecting the drug. Since formulations must be tampered with to snort or inject the drug, tampering is frequently a critical step along the path of drug abuse progression.

Effective Pain Treatment

Despite problems with misuse and abuse of prescription pain relievers, extended release (ER) formulations of opioids such as OxyContin® (oxycodone), Opana ER® (oxymorphone), and Kadian® (morphine) remain the mainstay of successful treatment with greater than 16 million prescriptions a year written in the US ($4.3 Billion market in 2009).  Market research has confirmed that there is a tremendous unmet need for safer formulations of these products (i.e. more tamper-resistant). The opportunity for a new product entering this market with competitive, differentiated product labeling is in excess of $1 Billion per year.


“Most participants in a market research study of high prescribers of ER Opioids are concerned about abuse potential with opioids, as the physicians say it is a possibility with every patient, despite careful screening and check points during treatment.”

(Jan 2010, G&S Research, Inc.)


“Opioid abusers seek fast onset euphoria, and therefore, typically rely on tampering (physical and/or chemical manipulation) to facilitate their preferred route of abuse”

- ABC News


“(COL-003) Gives me an option to write oxycodone XR, which I am not writing now, I need that option, I feel oxycodone is more effective than morphine in pain control. Potential for abuse for this (Col-003) is much less”

- Pain Management Specialist after reviewing COL-003 profile