Research Study Validates Technology for Abuse Deterrent Prescription Drugs

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Pisgah Forest, NC, December 8, 2010 — Pisgah Labs announced today the findings from a proof of concept study confirming Pisgah’s technology imparts abuse deterrence to commonly abused prescription drugs, particularly narcotics. The controlled study, conducted in dogs, was performed with the un-formulated active ingredient, hydrocodone, as modified according to a host of patent applications filed by Pisgah Labs with the United States Patent and Trademark Office (http://www.uspto.gov). Marketed hydrocodone products are highly susceptible to abuse and indeed, hydrocodone represents the most highly abused pain medication in the country. Since Pisgah’s technology converts the active ingredient to an abuse-deterrent form, the controlled study was performed using Pisgah’s abuse-deterrent hydrocodone compared with hydrocodone bitartrate, which is exclusively marketed by pharmaceutical companies. With the study’s performance evaluations done on the un-formulated active ingredients, a direct comparison was made between the two forms of active ingredient. The findings from the study confirmed Pisgah’s technology is a superior choice over the existing hydrocodone bitartrate for providing abuse deterrence.

Hydrocodone is most often abused by first extracting the active ingredient from the formulated product, then using the enriched opioid to get high. Hydrocodone isolated from existing commercial products provides a powerful “high” to the abuser since the enriched active is highly soluble in the mucosal membranes – like those found in the nose. With Pisgah’s hydrocodone, the opioid has been modified at the active ingredient level to prevent or inhibit both the extraction process from the formulated product and if extracted, to absorb slowly in the nasal mucosa so that an abuser does not get high – just highly disappointed.

In regard to the study, dogs were ideal to demonstrate the advantage of Pisgah’s modified hydrocodone versus the commercial alternative. Dogs were chosen because of their high nasal surface area, which would provide the highest sensitivity and differentiation between the two opioid forms. The intranasal dosing was also compared to results from oral dosing. The pharmacokinetic (PK) data was acquired for the opioid forms for both dosing regimens and the matrix comparisons performed for the two types of hydrocodone active ingredient. As was expected, hydrocodone bitartrate was readily absorbed through the nasal tissues and rapidly reached maximum blood concentrations as compared with Pisgah’s version of the active ingredient. With Pisgah’s hydrocodone, the intranasal application yielded a much slower rate of absorption into the blood stream with a lower Cmax occurring at nearly an hour after dose administration. Simply stated, Pisgah’s hydrocodone exhibits abuse deterrence when administered nasally.

The study findings from the oral administration were equally encouraging. Pisgah’s hydrocodone active ingredient was designed to have immediate release characteristics like those of hydrocodone bitartrate, yet still remain abuse deterrent. Indeed, the two forms had similar oral release profiles except the Pisgah hydrocodone, immediately after dose administration, exhibited an induction period before attaining the same release rate as the bitartrate salt. In fact, Pisgah’s hydrocodone exhibited performance characteristics representing the best outcome possible: intranasal administration confirmed abuse deterrent features while oral administration can be subjected to formulation techniques to yield an immediate release or extended release drug product.

Pisgah is currently engaged in final dose product development employing their patent pending technology and will soon be submitting the necessary regulatory filings to the FDA. Their technology represents a global solution to the abuse of opioid based narcotics and to the often abused attention deficit / hyperactivity disorder (ADHD) medications such as amphetamine and methylphenidate. For more information on Pisgah’s technology and licensing opportunities, visit http://www.pisgahlabs.com or call the contact listed below.