Reacting for a Healthy Life

Pisgah Labs Files Eighth Patent Aimed at Curbing Drug Abuse

While large pharmaceutical companies have been unsuccessful at addressing the nation’s prescription drug abuse problem—particularly of their opiate based drugs, one Western North Carolina company, Pisgah Labs, has filed its eighth patent application on a promising platform technology to accomplish the task. As larger companies have garnered superfluous headlines, Pisgah has quietly stayed the course to invent and develop a chemical methodology applicable to the pain medications most often abused. The technology was designed around six basic performance features needed to reduce drug abuse. These factors were:

  1. Provide a tamper-resistant / tamper-proof drug product presentation wherein extraction of the active ingredient was a low yielding process, both complex and un-economical
  2. the product presentation was capable of containing multiple defensive mechanisms to inhibit abuse
  3. 3) chewing, grinding or other physical manipulations of the dosage did not defeat the anti-abuse property
  4. 4) the active ingredient’s release rate in the body was unaffected by alcohol consumption
  5. 5) a track and trace feature was built-in to the active ingredient, and most importantly, the drug would work when properly administered but would not work when abused, notwithstanding overdose.

To someone intent on abusing a drug, the “perfect” abuse route generally requires isolation of the active ingredient from the dosage product. The intent is to obtain the active in a more concentrated form; the isolation may include purification steps and perhaps re-forming of a mineral acid (e.g. HCl) salt. In the concentrated form, the abuser indulges in the active to get high by administering the drug orally, or by injection, or through the mucosal membranes. Alternatively, some abusers resort to dose dumping wherein taking an extended release or some type of modified release formulated drug product with alcohol results in the entire active ingredient released at once. This so called dose-dumping technique, especially with opiate based drugs, often results in fatalities.

In general, routes of abuse administration (and other illicit or illegal activities) start with the ability to defeat the modified release properties the drug product contains and/or to circumvent the chemical and/or mechanical barriers intentionally designed into the product. Pisgah’s platform technology addresses the drug abuse issue at the active ingredient level which is then formulated into the actual dosage medication as a tablet or capsule. In this manner, the principle anti-abuse property starts at the molecular level with the active ingredient. Formulation can then provide additional defensive barriers to abuse.

Now, with their eighth patent application filed on the technology, Pisgah has initiated specific product development activities aimed at receiving FDA approval to conduct clinical trials on the first offering in a lengthy product pipeline. Their goal is to demonstrate the technology is soundly devised to intervene, interrupt and interdict drug abuse throughout the supply chain. Or in FDA jargon, to address abuse, misuse and diversion through sound science and demonstrated clinical results. Considering the breadth and depth Pisgah’s technology, it would appear they are well poised to meet the challenge.