DDS-08B:
Abuse/Misuse-Deterrent Formulation of Twice-Daily Oxycodone-Acetaminophen
It is estimated by the American Pain Foundation and others that up to 75 million people in the United States suffer from pain. In 2009, there were 288 million prescriptions, valued at US$15 billion, written for the treatment of pain. Of all the prescriptions written for pain, 87% (251 million) were written for opioid analgesics, making them one of the highest prescribed drug classes in the United States.
Opioid analgesics are delivered by various methods. The most widely used form is oral delivery, which can release the opioid immediately or over an extended period of time. Extended release (ER) opioids have many advantages over immediate release (IR) opioids, especially for patients suffering from chronic, persistent, or reoccurring pain. By their nature, ER opioids can contain up to six to eight times the active ingredient found in IR formulations.
Despite the benefits of ER opioids, serious health consequences could occur if the extended release properties are compromised, resulting in an immediate "dose dump" of a large amount of active ingredient. Dose dumping could occur with the unintentional misuse or intentional abuse of ER tablets by splitting, crushing, combining with alcohol, or dissolving in water.
Our Products
We are developing a twice-daily abuse and misuse-deterrent formulation of the combination analgesic oxycodone-acetaminophen based on our INTELLITAB™ technology platform. INTELLITAB™ provides for the extended release of single and combination drug medications while mitigating the risk of "dose dumping". INTELLITAB™’s proprietary delivery mechanisms maintain the extended release properties of the formulation if the tablet is broken, crushed or consumed with common beverages or alcohol. INTELLITAB™ technology also prevents intravenous injection after crushing and mixing with water, alcohol or other solvents. The platform is also designed to prevent intoxication after insufflation (snorting) of a crushed tablet.
Market Opportunity
Currently, there is no extended-release combination opioid product with abuse/misuse-deterrent properties on the market. Approximately 40 million prescriptions for IR and ER oxycodone-acetaminophen combination products were written in the U.S. in 2009.
Status
- Positive in vitro evidence of extended drug release after bisecting and crushing.
- Positive pharmacokinetics (PK) study results with both intact and crushed tablets demonstrative proof of principle in humans.
- Exploring partnership opportunities.