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Generics and Some Brands May Lose $7 Billion Pain Market as Pisgah Labs Develops Abuse Deterrent Products
Date:6/12/2013

PISGAH FOREST, N.C., June 12, 2013 /PRNewswire/ -- As controversy surrounds the recent FDA decisions concerning abuse deterrent forms of oxycodone drug products, Pisgah Laboratories, Inc. (www.pisgahlabs.com) achieves another technical milestone which may radically alter the landscape for pain medication regulations. Recently, the FDA ruled that the Abbreviated New Drug Applications (ANDAs) — competitive to Purdue Pharma's branded Oxycodone® — would no longer be considered if they did not possess abuse deterrent capability. The announcement's timing coincided with the day Purdue's patent for Oxycodone® expired and this regulatory ruling simultaneously delivered a devastating financial blow to would-be generic offerings and a strong message that the government is getting serious about abuse deterrence.

Previous releases by Pisgah Labs have revealed their current product development efforts are directed toward an abuse deterrent hydrocodone / acetaminophen combination product. Interestingly though, the abuse deterrent methodology used to intervene with the potential abuse of the controlled substance, hydrocodone, is also applicable to a variety of other commonly abused narcotics. Of particular interest to Pisgah are the opioid-based products almost exclusively used in pain management therapy and the Attention-Deficit Hyperactivity Disorder (ADHD) products such as Ritalin® and Adderall®. It's no secret that the rampant abuse of pain medications and the ADHD drugs has reached epidemic proportions in the US; it's also not surprising the FDA has taken strong action to curtail drug abuse activity.

In regard to Pisgah's product development efforts, the Company's president, Bill Bristol, stated, "We're committed to the careful development of abuse deterrent products incorporating our technology to
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SOURCE Pisgah Laboratories
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