Pisgah Labs’ P2P INTERVENTIONS™ Mission:

Pisgah Labs is committed to improving medically necessary pain medications that contain Active Pharmaceutical Ingredients (APIs) that by their design dramatically impede illicit drug use. With our success, the intersection of chemistry and healthcare will yield a broad range of controlled substance pharmaceuticals possessing performance enhancing features which thwart drug abuse and lessen a product’s abuse potential and appeal to would-be addicts.

First, let’s define what comprises a pharmaceutical pain medication (tablet or pill) such as Vicodin®, Lortab®, Oxycontin®, etc.

A drug product such as a tablet dosage contains two basic parts:

1. The Active Pharmaceutical Ingredient (API) which abusers seek to obtain their “high”; and
2. Inert ingredients (excipients) blended with the API to provide a compressible tablet of the correct therapeutic dosage.

An inherently weak approach to abuse deterrence = Abuse Deterrent Formulations (ADFs)

The pharmaceutical industry is relying on their historical expertise in formulation development to blend the API with various excipients to yield abuse deterrent products in immediate release (IR) or extended release (ER) presentations.

…but ADFs are analogous to a place where the API is stored that remains vulnerable to theft.

An ADF is built to safeguard its valuable assets (the API) from theft (by abusers). The vulnerability to abuse arises from the following:

1. A single Abuse Deterrent Formulation technique is unable to work identically among the variety of prescription pain, AD(H)D and pseudo-ephedrine products, dosages or strengths; and
2. Potential abusers easily circumvent the ADF and thus achieve their intended “high” due to the API remaining unsecured.

The vulnerability and consequence

An ADF remains penetrable and is insufficient to inhibit mechanical or chemical extraction of the API. In contrast, a bank’s vault is much more difficult to breach unless opened under the proper supervision and authority of the patient and the doctor. P2P INTERVENTIONS™ provides the bank vault built for protecting any pain medication from abuse yet allows access to the vault when the drug is used for its intended purpose.

P2P INTERVENTIONS™ distinguishing approach

P2P INTERVENTIONS™ focuses specifically on the Active Pharmaceutical Ingredient to interrupt abuse at the heart of the problem—at the active ingredient level whatever formulation or proposed ADF in which the active may be used.

P2P INTERVENTIONS™ becomes analogous to the bank’s vault by safeguarding the API from extraction!

Pisgah Labs’ P2P INTERVENTIONS™ went well beyond a simple bank building structure and using organic chemistry, built an impenetrable vault around the active ingredient. This unique approach safeguards against the possibility of API extraction, mis-use, abuse from potential drug abusers and drug counterfeiting. Additionally, the chemical process is directed at the API with P2P INTERVENTIONS™ methodology applicable to a full range of prescription pain, AD(H)D and pseudo-ephedrine products regardless of the formulation in which they are used.

How will your innovation reduce prescription drug abuse in the USA?

With the removal of the non-medical “high” component from the drug product, the innovation alleviates the demand for that product based on intended abuse. P2P INTERVENTIONS™ has removed all of the key elements sought by abusers to attain their “high”, including:

1. Extraction of the API is difficult and costly for a “street chemist”;
2. The drug’s euphoric response is unavailable from grinding or chewing;
3. The API is not bio-available in the mucosal membranes for absorption;
4. The API cannot be melted for injection;
5. The API is resistant to dose dumping—i.e. it does not release rapidly when mixed with alcohol.

As if the above performance features didn’t make abusing a prescription product difficult enough, the really bad news for the potential drug abuser is the innovation is commercially viable across the entire family of opioid and narcotic pain medications.

Diversion and counterfeiting

An outfall of prescription drug abuse is both the diversion and counterfeiting of controlled substance pharmaceutical products. P2P INTERVENTIONS’™ innovation not only lessens the abusers’ demand for a product, but has ramifications that decrease diversion and counterfeiting. Products containing P2P INTERVENTIONS’™ active pharmaceutical ingredients allow a means for “out-of-package” track and trace capabilities due to the API’s unique characteristics when examined in the laboratory. When a drug product is “out-of-package”—it’s original packaging with barcodes and / or RFID—precise identification of the product is difficult. APIs utilizing P2P INTERVENTIONS’™ technology allow for definitive identification of the drug and provide the additional benefit to strengthen law enforcement’s efforts to combat prescription drug abuse, diversion and counterfeiting.

What resources and government approvals are necessary to commercialize this innovation and have you obtained them?

With abuse deterrence receiving wide-ranging attention from a multitude of organizations, government agencies and regulatory bodies, a predictable route to commercialization is essential. First, Pisgah’s innovation has led to over thirty patent filings and issuance of US Patent 8,211,905 is illustrative of the first, flagship product to be introduced. Additionally, Pisgah has met with the FDA and confirmed the most direct regulatory pathway required for gaining the FDA’s market approval for the drug. Additional confidence to P2P INTERVENTIONS’™ approach was gained through successful animal studies which confirmed that the fundamental concepts would yield practical performance features. Importantly, Pisgah Labs is positioned well to commercialize the abuse deterrent products; the company holds the necessary FDA and DEA certifications, and has the proven expertise to perform such development work.

By whom and how widely must the innovation be adopted to produce measurable reductions in prescription drug abuse in the US? And, how do you intend to foster adequate market adoption of the innovation?

Pisgah Labs and its P2P INTERVENTIONS™ process provides an integrated solution to the complex variables associated with producing abuse deterrent products. As such an integrated answer to questions 3 and 4 seem appropriate. Physician and practice liability for patient drug abuse (through the REMS program) is a market driver gaining momentum. Achieving market awareness and adoption is vital to any new product launch. However, the abuse deterrent pharmaceutical marketplace is evolving and so too are the vast regulations accompanying pharmaceutical endeavors—while well intended, they often burden marketing campaigns. That aside, Pisgah Labs asserts that measurable reduction of abuse and adequate market penetration needs to be achieved on a broad front which is achievable only by an innovation applicable to all the pain, AD(H)D and pseudoephedrine products which are commonly abused.

Reiterated here, all pharmaceutical products have an active ingredient and accordingly, Pisgah Labs addresses abuse deterrence at the active ingredient level in a fashion that allows for a tailored fit to each targeted drug. Adoption, acceptance and abuse reduction observed for Pisgah’s first product (hydrocodone), will have a force multiplier effect for each succeeding product—oxycodone, methadone, oxymorphone, hydromorphone, as well as addressing abuse of the AD(H)D drugs methylphenidate and dextro-amphetamine. The culmination of multiple product offerings utilizing P2P INTERVENTIONS™ will be Pisgah Labs’ contribution to what is sure to be a collaborative effort along numerous fronts to battle prescription drug abuse.