(Pisgah Forest, NC—November 12, 2012) Pisgah Laboratories, Inc. (www.pisgahlabs.com) has recently received three Notices of Allowance for United States Patents related to its abuse deterrent medications platform. Earlier this year, Pisgah obtained US Patent 8,211,905 emanating from work conducted at their facility in Pisgah Forest, NC. The latest Notices represent additional milestones to what Pisgah believes will be significant advances in the war on drug abuse.
Two of the Notices relate to “Opioid Salts and Formulations Exhibiting Anti-Abuse and Anti-Dose-Dumping Properties”, and the third is entitled, “Salts of Physiologically Active and Psychoactive Alkaloids and Amines Simultaneously Exhibiting Bioavailability and Abuse Resistance”. Pisgah indicates these patent allowances are the foundation to what they expect to be a broad intellectual property portfolio encompassing narcotics, obesity treatment drugs, and high abuse-potential medications used to treat attention deficit hyperactivity disorder, AD(H)D.
Pisgah’s approach to counter drug abuse is to re-vamp the chemistry of abused medications so as to remove the features which enable abuse—while still retaining the intended medical benefit when the drug is used properly. To do this, Pisgah has modified the active ingredient in the drug product to have properties which are difﬁcult to extract from the dosage form (the pill) and to yield a drug substance that is ineffective when used illicitly in “alternate routes of administration”. This chemical and physical selectivity imparted to the drug substance—the active pharmaceutical ingredient (API), now enables drug product manufacturers to prepare specialty pharmaceuticals with highly refined features and benefits.
Pisgah’s president and CEO, Bill Bristol commented, “the broad applicability of these innovations offers a new hope for defeating the drug abuse cycle while revitalizing an underserved market”. Indeed, Pisgah’s approach allows for advancement on many fronts supporting abuse-deterrent product development for a range of pain, AD(H)D and bariatric medications. As bureaucracy and regulations have strangled an otherwise vibrant drug development industry, Pisgah’s inventions offer a scientific underpinning to the FDA’s objectives to reduce drug abuse and provide a predictable and viable financial mechanism to potential patent licensees.
Bristol further commented, “[that} tangible accomplishments such as allowed patents, animal studies and IND filings serve to further validate the technology and make it a credible business venture with a high probability of success”. And, Pisgah is doing their part to deliver on a complex set of expectations by internally funding the product development work on an abuse deterrent hydrocodone product. As each step of product development progresses, new quality standards are achieved and the unique features and beneﬁts of the technology are confirmed.
Bristol‘s only lament is the absence of multiple products being developed simultaneously in order to hasten these valuable products to market. He concedes that large pharmaceutical companies are hesitant to commit to new opportunities until essentially all risks are removed. This reluctance is enhanced by global market uncertainties and the poor business climate created by enormous government deficits. Pisgah’s product development activities are self-funded and clearly reflect this company’s commitment to improving the safety of beneficial medications while pursuing an entrepreneurial return. As Pisgah continues on its progression of patent allowances and product development, it’s their intention to collaborate in licensing arrangements to help feel empty pipelines.