PISGAH FOREST, N.C., March 5, 2013 — Pisgah Laboratories, Inc. has announced the launch of a new website to assist in its abuse deterrent technology licensing efforts. Over the past several years, Pisgah (www.pisgahlabs.com) has elucidated a technical means to address the Nation’s drug abuse epidemic as declared by the Center for Disease Control (CDC). The impact of illicit drug use in America is financially staggering and the statistics are well summarized in a report by the Office of National Drug Control Policy (https://www.ncjrs.gov/ondcppubs/publications/pdf/economic_costs.pdf). Pisgah’s patented technology is aimed at introducing abuse deterrent features at the active ingredient level with laboratory results indicating broad applicability to many of the most notoriously abused narcotics and psychotherapeutic medications.
P2P Interventions™, www.P2PINTERVENTIONS.com, is the trademark Pisgah Laboratories has adopted for its platform technology designed to significantly reduce recreational drug abuse of narcotics and psychotherapeutic medications. Pisgahhas researched and patented pathways for introducing new narcotic products possessing chemical and physical characteristics, which make recreational drug use not only difficult, but essentially un-economic to the abuser. Unique to Pisgah’s approach are that modifications to the salt form selected for the active ingredient impart additional safety features without compromising expected efficacy of the drug. For product manufacturers, additional protective measures can also be added from formulation techniques incorporating the abuse deterrent active ingredient.
As with any pharmaceutical endeavor, the pathway to commercialization is fraught with many challenges and obstacles, but P2P Interventions™ is armed with an essential component for success in today’s challenging markets. At its core, P2P Interventions™ is backed by numerous US patents which encompass the technology’s groundwork. Additionally, and through Pisgah Labs, new discoveries and improvements on the technology are being routinely submitted to the US Patent & Trademark Office as Pisgah maintains its efforts to fully detail the technical breadth of the inventions. These patents afford potential licensees the opportunity to introduce new pain medications with patent protected revenue streams.
An ongoing applied research program at Pisgah Labs is also complemented by a modern and capable active pharmaceutical ingredient manufacturing facility, which possesses FDA and DEA certifications. This asset is an important factor in implementing P2P Interventions’™ licensing strategy since the technology patents address abuse at the active ingredient level—before formulation and tableting. These latter activities are being performed by a Contract Manufacturing Organization (CMO) intimately familiar with the technology, formulation, and controlled substance processing. Overall, P2P Interventions™ provides a technology portal for a branded marketing group aspiring to participate in new, patent protected products. As Pisgah’s president, Bill Bristol , has stated, “P2P Interventions™ has the provision, and holds the promise of significantly reducing the Nation’s drug abuse problem”.
In the coming year, P2P Interventions™ will continue its product licensing program while Pisgah Labs advances its proof-of-concept activities into humans. Results from clinical trial evaluations of its combination hydrocodone / APAP lead product are expected later this year with Bristol commenting that “Pisgah is confident in its technical findings and [that] as a private company, our expenditures on clinical trials would not occur without a high probability of success”. Ultimately, the technical underpinnings P2P Interventions™ will share with a licensee include utilizing its technical accomplishments and tangible assets to support a market shift to abuse deterrent drug products. Such a shift away from easy-to-abuse products to pain medications containing abuse deterrent features is estimated to save the Nation over $200 billion per year in expenses associated with drug abuse.