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Abuse Deterrent Hydrocodone / Acetaminophen Leads NDA Pipeline
Date:1/19/2011

PISGAH FOREST, N.C., Jan. 19, 2011 /PRNewswire/ -- As Pisgah Laboratories, Inc. continues development of its lead abuse deterrent opioid product, it will soon begin scale-up of its patent-pending form of hydrocodone. Pisgah has developed a specialized salt form of hydrocodone which imparts abuse deterrent properties to a dosage product. Pisgah will manufacture its hydrocodone salt for clinical trials in their FDA / DEA registered facility. Accordingly, Pisgah's pilot plant has recently undergone appropriate modifications to convert the often, and readily abused, hydrocodone bitartrate currently used by the pharmaceutical industry to Pisgah's abuse deterrent form. Pisgah's approach to the abuse epidemic thwarts attempts by potential abusers to de-formulate hydrocodone products for abuse purposes.

Typically, abusers extract the active ingredient from a formulated dosage product. The principal extraction procedure popularly employed by hydrocodone abusers is the "cold water method." The abuser grinds up the hydrocodone bitartrate / acetaminophen combination tablets and extracts them with a minimum amount of cold water to separate the insoluble and potentially toxic acetaminophen (APAP) from the water soluble hydrocodone bitartrate. The abuser then drinks the water extract and experiences a "high" or "rush." In contrast, Pisgah's hydrocodone salt is not amenable to such an extraction procedure and thus defeats the abusers' attempt to isolate the narcotic component from the dosage product.

Pisgah recently completed an alternate species animal study comparing inhalation properties of hydrocodone bitartrate with their abuse deterrent hydrocodone. The pharmacokinetic study clearly differentiated the two forms thus validating Pisgah's approach in defeating nasal abuse of hydrocodone. Similarly, the study results also confirm proper oral administration allows for the drug to work as intended. These results, coupled with the extraction protection available t
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SOURCE Pisgah Labs, Inc.
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