Pisgah Labs receives QTDP grant to accelerate abuse deterrent technology

Nov 4 2010

Pisgah Labs, Inc. (http://www.pisgahlabs.com), an innovative drug development and active ingredient manufacturer located in Western North Carolina, has received a substantial federal grant. The Qualifying Therapeutic Discovery Project Program (http://www.grants.nih.gov/grants/funding/QTDP_PIM/index.htm) made funding available to promising new technologies ready for pre-clinical or clinical trials, and to support filing of a New Drug Application (NDA) with the United States Food and Drug Administration. Pisgah Labs solicited the grant monies in order to accelerate their abuse deterrent technology incorporated into their first product, hydrocodone. The grant will be used to fund on-shore pre-clinical and clinical trials in furtherance of Pisgah's FDA filing for an abuse deterrent form of hydrocodone.

The nation is experiencing a prescription drug abuse epidemic -- a condition highly detrimental to the abuser, a burden on society and one incurring huge costs to our infrastructure. Hydrocodone is a medically necessary pain medication and with over one-hundred million prescriptions annually, it's the most abundantly prescribed narcotic. Consequently, and not surprisingly, it's the most abused narcotic in the country.

Pisgah Labs' technology platform addresses these global problems in the context of the FDA's drug safety initiative (REMS). The methodology operates at the active ingredient level by forming a specialized salt form of the opiate. The desired abuse deterrent performance features provide the first line of defense against abuse and dosage formulation techniques may (optionally) provide additional abuse deterrent features.

In laboratory tests, Pisgah's technology prevents hydrocodone solubility in the pH range common for mucosal abuse and hence, abuse pathways are mitigated. Further, benefits arise from the material's poor solubility in organic solvents and in particular, ethanol does not accelerate the inherent dissolution profile. Initial product formulation efforts employing the Pisgah technology incorporate a chemical marker for an out-of-package "track and trace" system useful by law enforcement in the controlled substance supply chain. The in vitro tests also demonstrate the ability to provide efficacious and medically necessary drug products while simultaneously inhibiting drug misuse, abuse or tampering.

Pisgah plans to utilize the grant monies for further refinement of the formulated dosage product, to prepare clinical trial materials and to execute clinical trial protocols designed to demonstrate bioequivalence with existing commercial products (principally, through cross-over pharmacokinetic studies). More importantly, and to which the benefit of the technology may be realized, Pisgah plans to conduct "likability" studies in opiate tolerant / drug abusers to confirm the in vivo results correlate with the in vitro laboratory findings.  

As Pisgah proceeds with its drug product development pipeline of abuse deterrent products, Pisgah recognizes the importance of partnering with interested companies to bring innovative and novel products to the marketplace which have a huge societal impact. Currently, Pisgah is in intellectual property licensing negotiations with several prominent pharmaceutical companies to discuss how Pisgah's technology could accelerate market access to abuse deterrent forms of the more commonly abused pain and attention deficit / hyperactivity disorder (ADHD) medications. Besides the abuse potential associated with pain relief medications such as hydrocodone, oxycodone and similar narcotics, methylphenidate and amphetamine, which are commonly used for ADHD treatment, are also reported to have high abuse rates. New abuse deterrent drug products for ADHD based on Pisgah's technology are in progress and development efforts have yielded promising results.  

In addition to their product development program, Pisgah anticipates additional patent allowances soon supporting its commercial efforts and the broader foray into abuse deterrent products.