Evaluated by in vitro testing
Hysingla ER is formulated with physicochemical properties intended to make the tablet more difficult to manipulate for misuse and abuse
Physical and chemical tablet manipulation studies were performed to evaluate the success of different extraction methods in defeating the extended-release formulation.
Physical and chemical tablet manipulation studies included1:
- Physical manipulation
- Dissolution
- Solvent extraction
- Syringeability
- Organic extraction
Results of in vitro testing
- Hysingla ER resists crushing, breaking, and dissolution using a variety of tools and solvents and retains some extended-release properties despite manipulation
- When subjected to an aqueous environment, Hysingla ER gradually forms a viscous hydrogel (i.e., a gelatinous mass) that resists passage through a hypodermic needle
- The outcome of these studies supports that by incorporating hardness and gelling into a drug formulation, the time and effort needed to manipulate the drug for abuse and misuse is increased
- Abuse-deterrent properties do not prevent or reduce the risk of addiction2
- Abuse of Hysingla ER by the intravenous, intranasal, and oral routes is still possible
- All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use
- With parenteral abuse, the inactive ingredients in Hysingla ER can result in local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis and valvular heart injury, embolism, and death
- Additional data, including epidemiological data, when available, may provide further information on the impact of Hysingla ER on the abuse liability of the drug. Accordingly, section 9.2 (titled Abuse) of the Full Prescribing Information may be updated in the future as appropriate
