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July 8, 2014

Purdue’s hydrocodone bitartrate tablets granted priority review designation

Purdue Pharma has been granted priority review designation by the US Food and Drug Administration (FDA) for its hydrocodone bitartrate extended-release tablets for treatment of chronic pain.

By Mekala ShivaramPrasad

Purdue Pharma has been granted priority review designation by the US Food and Drug Administration (FDA) for its hydrocodone bitartrate extended-release tablets for treatment of chronic pain.

The once-daily, single-entity pain medication was formulated to incorporate abuse-deterrent properties designed to make the product more difficult to manipulate for misuse or abuse by various routes of administration.

Purdue Pharma chief medical officer and regulatory affairs vice-president Todd Baumgartner said: "It is imperative to provide healthcare professionals with an array of therapeutic options to ensure chronic pain patients receive individualised care.

"If approved by the FDA, this product will be a valuable therapy for treating chronic pain."

"If approved by the FDA, this product will be a valuable therapy for treating chronic pain, and it is also designed to deter misuse and abuse by various routes of administration."

In April, the company filed a new drug application with the FDA seeking authorisation to market its hydrocodone bitartrate tablet. The FDA has set a target action date under the Prescription Drug User Fee Act of October 2014.

A series of manipulation and extraction studies and clinical abuse liability studies have been conducted by the company to assess the abuse-deterrent properties of the hydrocodone bitartrate extended-release tablets.

Purdue Pharma had presented the data from these clinical studies assessing the safety, efficacy, and abuse liability of this investigational medication at the 33rd Annual Scientific Meeting of the American Pain Society.

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