The FDA has approved a new formulation of Endo Pharmaceuticals' ($ENDP) opioid analgesic, Opana ER, that's intended to resist being crushed. Endo says in a statement that the tablets are based on a formulation technology from German pain specialist Grünenthal Group, a collaborator in the drug's development.
The technology, called Intac, provides "tailor-made release properties to achieve bioequivalence" to pills based on more conventional and easily crushed formulations, Grünenthal says in its own statement. The company explains that "polymer compositions and a unique manufacturing process yield tablet formulations with crush-resistant properties while preserving desired release characteristics."
Endo says also that the U.S. Patent and Trademark Office will issue a patent for the formulation, stretching Opana ER protection to November 2023.
Crush resistance addresses the tendency of drug abusers to crush opioid pills for smoking, inhaling or injection, reports Drug Store News.
The FDA found that the drug, scheduled for a 2012 launch, is otherwise identical to the previous formulation, already on the market. It exhibits "no significant difference" in API absorption characteristics compared with the original Opana ER formulation, the statement says.
The new formulation will bear the same name and Endo says it expects a "seamless transition" in 2012. Opana ER will be available in the same dosage strengths, color and packaging, as well as tablet size and shape.
- here's the story
- see the Endo release
- and the Grünenthal announcement