Medication Monitor



Generic Name (Trade Name—Company)
Notes
December 12, 2011

Oxymorphone

(Opana ER—Endo)
New formulation aimed at reducing abuse

Uses:

Relief of moderate-to-severe pain

A new crush-resistant formulation of Endo’s oxymorphone extended-release tablets, Opana ER, has been approved by FDA, according to a news release on the manufacturer’s website. This new formulation uses INTAC technology from Grunenthal, which is partnering with Endo to develop this product.

The tablets will be marketed in the same dosage strengths, color, packaging, and tablet size and shape as the original Opana ER tablets. In addition, there are no significant differences in the rate and extent of absorption of the therapeutic ingredient between this new formulation and the original formulation.

The original tablets will be phased out gradually next year as patients are transitioned to the new formulation. Extended-release oxymorphone tablets are indicated for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.