FDA Approves Crush-Resistant Painkiller
Federal regulators approved a crush-resistant version of an Endo Pharmaceutical pain treatment which comes with patent protection until 2023.
Endo partnered with German drugmaker Grunenthal to develop a new version of Opana ER, which is designed to make it more difficult to abuse the drug. Opana ER releases a painkiller over 12 hours, and extended-release drugs can often be abused if they are crushed, which defeats the purpose of a time-release chemical.
The new Opana ER version will go by the same name and come in the same dosage strengths, color and packaging as the older version. Endo, based in Chadds Ford, Pa., said Monday it was committed to a "seamless transition" next year to the new formulation.
Citi analyst John T. Boris said he that while he expected U.S. Food and Drug Administration approval of the new version, he raised his earnings estimates for Endo from 2012 through 2014.
He also said he assumes Endo will switch the entire Opana ER franchise to the tamper-resistant version in the first half of next year, before the old formulation's U.S. patent protection expires Jan. 1, 2013. Boris expects an "orderly commercial shift" to the new formulation to prevent a decline in prescriptions.
Opana ER generated $97.8 million in third-quarter sales.
Date: December 12, 2011
Source: Associated Press