Clinical Study of Abuse-Deterrent Formulation to Suppress…

Chronic pain affects millions of Americans, with a prevalence higher than heart disease, cancer, and diabetes combined. Chronic pain resulting in osteoarthritis and cancer is often treated with opioid medications. Opioid medications can provide short-, intermediate-, or long-acting analgesia. Hydrocodone is one of the currently approved formulations available in IR and ER forms. Extended-release forms are formulated as both combination products with acetaminophen or non-steroidal anti-inflammatory drugs or single-entity drug. All currently approved oral opioids have limitations, including continued concern about abuse and misuse in the intended patient population. Like other opioids used in analgesia, hydrocodone can be abused and is subject to criminal diversion. A number of the abuse-deterrent formulations in development and available on the market utilize hard-to-crush tablet technologies. Frontage possesses wide experience in running studies with controlled substances. Frontage provided full support in developing the protocol, revising study methodology, developing full package for IRB submission, including Informed Consent Form.

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