Grunenthal insists crush-proof tablet works after Endo pulls Opana sNDA

Irish drugmaker Endo Pharmaceuticals ($ENDP) has pulled away from its aim to label pain drug Opana ER as abuse-deterrent. This was a matter of concern for crush-proof tablet developer Grunenthal, which provided Endo with its technology--and this week still insists it is beneficial.

Grunenthal’s Intac technology is a polymer that makes tablets difficult to crush, preventing those looking to abuse the opioid from taking it in a way other than prescribed. Endo originally announced back in 2012 that it would be manufacturing Opana ER only as its reformulation with Intac, citing patient safety.

But earlier this month, Endo slowed its roll for a supplemental new drug application with the FDA, saying it would wait for additional data before advancing the application. This follows several years of declining sales due to generic competition and the company has long petitioned the U.S. agency to acknowledge the drug was crush resistant and require competitors to provide data showing theirs lived up to Opana’s standards. The FDA declined, noting that the tablets could still be compromised.

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Grunenthal stands by its technology, though. A spokesman told inPharmaTechnologist: “We believe that the properties of Intac add signicant[ly] to prescription drugs. … Grunenthal will continue investing into the advancement of the Intac technology.”

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