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 through Pisgah's technology, provide the first practical solution to hydrocodone drug abuse.
Pisgah's product development program is now focused on clinical trial production. Since hydrocodone is principally used in combination products with other actives such as acetaminophen, Pisgah has selected dosage strengths of hydrocodone / APAP meeting the FDA's new limits for acetaminophen, http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm165107.htm, and comparable to existing commercial products so that side-by-side abuse deterrent comparisons can be performed. One study in particular, called a likability study, will be performed using known "recreational" users. From results to date, these users will predictably find Pisgah's hydrocodone "un-likable." Indeed, inhalation or other abuse routes of administration -- such as application to the mucosa -- will not yield the desired "high."
Pisgah Laboratories continues to file patent applications covering the broad applicability of their technology to hydrocodone as well as to other narcotic products. At last count, fourteen applications were in various states of prosecution before the US Patent and Trademark Office covering opioids, anti-depressants and the ADHD medications dex-amphetamine and methylphenidate. While hydrocodone has advanced from the laboratory into the development stage, other abuse deterrent products will soon follow an identical and established development template.
Pisgah's technology provides an integrated approach to solving three principal concerns within the medical community: 1) improving patient care; 2) reducing medical practice liability; and 3) reducing barriers for treating pain. Clearly, abuse deterrent products improve the health of the nation's population by reducing drug abuse. Secondly, the regulatory initiatives to reduce abuse impose liability on the medical community requiring identification and mitigation of patient drug abuse. Without exception, these well-intended actions erect barriers to pain treatment for legitimate patients and enhance the perceived liability of doctors. Pisgah anticipates its new products will be well-received by all stakeholders interested in reducing the nation's drug abuse epidemic.