(Pisgah Forest, NC—May 17, 2011). Responding quickly to the FDA’s proclaimed new limits on acetaminophen in prescription painkiller combination products, Pisgah Laboratories, Inc., www.pisgahlabs.com files a patent application on abuse deterrent features for opioid drug products. Filed with the US Patent & Trademark Office (www.uspto.gov), this new patent application is the eighteenth filing for Pisgah and represents a substantial R&D effort directed toward a broad-based platform technology addressing the horrific effects of drug abuse.
Drug abuse has crept into every facet of global society with untold human costs and is an incalculable financial drain on a nation. Governmental efforts to stem drug abuse are essentially ineffective and recidivism high. At a time when the United States needs a “break”, drug abuse continues to squander human talent and resources, but Pisgah Labs’ scientists remain focused on reducing abuse of popular prescription drugs. Indeed, nearly one hundred and forty million prescriptions are written annually for hydrocodone in combination with acetaminophen (APAP).
Many of these products, containing APAP in large dosage amounts, are purported to cause liver toxicity and the FDA has established new limits for the amount of APAP allowed. The new rulings come at a favorable time in Pisgah’s product development cycle as they develop abuse deterrent hydrocodone / acetaminophen products.
Unlike older attempts to manipulate the abuse potential by formulation, Pisgah has scientifically addressed the abuse potential at the active ingredient level. Pisgah has identified new salt forms of hydrocodone which significantly improves its performance features compared with hydrocodone bitartrate currently used in the industry. Indeed, Pisgah has avoided the pitfalls often found in commercializing pro-drugs or relying solely on formulation techniques to solve complex problems. Pisgah has identified salt forms of nearly all the commercial opiates used in prescription pain medications which will impart abuse deterrent features. The drug abuser will find it more difficult to separate the active ingredient from the dosage form, and the active will be far less soluble in the abuse-route mucosa (nasal, vaginal, rectal). However, it is important to note, the drug will perform properly when used as intended by oral administration—and when taken as prescribed, the release of the drug is not accelerated by drinking alcohol.
As for an integrated commercial offering covering other popular pain medications, Pisgah is continuing their research efforts while aggressively pursuing a development program for hydrocodone / acetaminophen combination products. In laboratory testing, Pisgah has shown they can “adjust” the properties of the new salts to yield immediate or controlled release versions. In general, the drug development pathway can be quite tortuous with unexpected events occurring such as the FDA’s mandate to reduce acetaminophen levels in products like Pisgah is developing. Fortunately, Pisgah sees this change more as an opportunity than a difficulty. As Pisgah’s President, Bill Bristol commented, “The mandated lower levels of acetaminophen allows for our technology’s benefits to shine and not to be eclipsed by the health issues raised by higher levels of acetaminophen in combination products”.
With eighteen patent applications and more on the way, Pisgah’s intellectual property stable continues to grow, and is applicable to dozens of abused prescription drugs. Pisgah’s technology provides an integrated solution to three principal concerns within the medical community: 1) improving patient care, 2) reducing medical practice liability, and 3) reducing barriers for treating pain. Pisgah anticipates its new products will be well received by all stakeholders interested in reducing the Nation’s drug abuse epidemic.
For more information or to discuss licensing opportunities, please contact:
Todd Stamps, Business and Market Development, 803-212-8224