The deal will see Japan’s Daiichi sell MorphaBond in the US in return for an upfront fee and royalty payments. The firm will also commercialize a second undisclosed opioid product if it goes on to be approved by the US Food and Drug Administration (FDA).
Both drugs use Inspirion’s SentryBond anti-abuse technology, which is designed to make pills resistant to cutting, crushing, or breaking. In addition, when the pills are subjected to a liquid environment they form a viscous material that resists passage through a needle.
MorphaBond was approved by the FDA in 2015 for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
US opioid abuse
Concerns about the misuse of opioid medications in the US have increased significantly in recent years.
To address this, the US FDA has encouraged drug firms to use anti-abuse technologies to try and prevent misuse.
In April last year the agency released final guidance explaining to manufacturers how to conduct studies to demonstrate that an opioid formulation has abuse-deterrent properties.
The abuse deterrent properties suggested by the FDA include physical and chemical barriers to abuse, agonist/antagonist combinations, aversion techniques to create unpleasant effects if a dosage form is manipulated and prodrugs.