Pisgah receives USPTO Notice of Allowance for drug abuse solution

Pisgah Laboratories, Inc. (www.pisgahlabs.com) received Notice of Allowance from the United States Patent and Trademark Office (www.uspto.gov) for its patent application entitled "Opioid Salts and Formulations Exhibiting Anti-Abuse and Anti-Dose Dumping Properties." Pisgah began pursuing a technology platform in 2006 that addresses the nation's drug abuse epidemic and this patent is the first in what is expected to be a large estate of allowed patents protecting Pisgah's discoveries. Fortunately, these innovations represent a readily available game-changer for altering the destructive path of drug abuse.

Prescription drug abuse has reached epidemic proportions in the US and Pisgah Labs is emerging as the technical leader in providing realistic solutions to a difficult problem. According to Dr. Cliff King, Pisgah's Vice President, "Pisgah has employed its expertise in chemistry to simultaneously address multiple routes of prescription drug abuse through an integrated technology platform." Pisgah's recently allowed patent covers a new form of hydrocodone to replace the often abused hydrocodone bitartrate now used in pain medications. While highly genericized, hydrocodone is best recognized by brand names such as Vicodin®, Lortab® and Norco®. These products, which also contain acetaminophen (or APAP), are receiving scrutiny from the FDA and product manufacturers are being subjected to a mandate to lower the APAP levels contained in their products. Pisgah's patent allowance provides for an abuse-deterrent form of hydrocodone to be incorporated into these products inclusive of the new acetaminophen safe level standards.

Indeed, Pisgah's development of abuse deterrent hydrocodone / acetaminophen combination products is only the first in a series of pain and attention deficit disorder medications Pisgah has in its drug pipeline. Their technology platform is equally applicable to pain medications such as Oxycontin® (oxycodone) or to the AD(H)D therapies employing Adderall® (d-amphetamine) or Ritalin® (methylphenidate), and Pisgah has patent applications under examination on these developments, too. In the face of increasing death rates, Pisgah's innovations represent a practical answer to medical professionals' dilemma -- to provide relief to a patient in legitimate need of treatment yet eliminate or lessen the potential for drug abuse. And, statistics have shown drug abuse may not be by the patient, but 70% of the abusers obtained the drug from a family member or friend. Similarly, and disturbingly, deaths have also been reported of patients in drug abuse programs actually abusing the methadone they were provided to wean them from their drug abuse behaviors. Here, too, Pisgah's technology uses chemistry to shut down the abuse pathways via "alternate routes of administration," i.e. the body's mucous membranes.

As mentioned above, Pisgah's solution to the drug abuse epidemic was designed as an integrated approach and the chemistry employed also addresses the serious abuse behavior of dose dumping. For extended release pain medications, the amount of active ingredient incorporated into the pill or tablet is quite high and is designed through formulation techniques to release over time. Abusers, intending to get the quick rush, or "high," take a tablet and follow it by drinking an alcoholic beverage to release the entire amount of the active ingredient at one time. For extended release opioid narcotic pain medications, such an immediate release of the powerful active ingredient can quickly lead to death. Pisgah's innovations chemically modify the opiate to prevent the rapid release of the active ingredient in the presence of alcohol.

As Pisgah expands its intellectual property estate and progresses with its development milestones, they are also in discussions and are seeking licensing and co-development partners to accelerate introduction of these life-saving products.