Monday, July 21, 2014

FDA Prioritizes Review of 'Abuse-Deterrent' Painkiller

Purdue Pharma LP’s hydrocodone bitartrate tablet (HYD) is undergoing “priority review” by the Food and Drug Administration (FDA), the company recently announced.

Reports said the tablet, if approved, will be the first painkiller with an “abuse-deterrent formula.” Such a formula will make it harder for the drug to be crushed or liquefied so it may be snorted or injected by drug abusers.

Market Watch pointed out that the FDA only gives priority review to new drugs that propose significant and improvement to the safety and effectiveness of existing drugs.

"This is another milestone in our effort to offer patients and health professionals a portfolio of pain medications with abuse-deterrent technology," Mark Timney, President and CEO of Purdue Pharma, was quoted saying.

Todd Baumgartner, MD, MPH, Vice President of Regulatory Affairs and chief medical officer of Purdue Pharma said that if approved by the FDA, the tablet “will be a valuable therapy for treating chronic pain.”


Read more: http://www.benzinga.com/14/07/4716634/fda-prioritizes-review-of-abuse-deterrent-painkiller#ixzz388wHoBnj

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