Pisgah Laboratories Develops Abuse-Deterrent Hydrocodone Product

Strategic Insights -

Pisgah Laboratories, Inc. is making significant progress in developing a lead abuse deterrent opioid product, with plans to soon begin scale-up of its patent-pending form of hydrocodone. The company has successfully developed a specialized salt form of hydrocodone that imparts abuse deterrent properties to a dosage product. This innovative approach thwarts attempts by potential abusers to de-formulate hydrocodone products, addressing the growing concern of opioid abuse.

Key Takeaways:

  • Pisgah Laboratories has developed a patent-pending form of hydrocodone with abuse deterrent properties, which will be manufactured in their FDA/DEA registered facility for clinical trials.
  • The company's approach defeats the "cold water method," a popular extraction procedure used by abusers to isolate the narcotic component from the dosage product.
  • A pharmacokinetic study comparing inhalation properties of hydrocodone bitartrate with Pisgah's abuse deterrent hydrocodone validated the effectiveness of the company's approach in defeating nasal abuse.
  • Pisgah's product development program is focused on clinical trial production, with a selection of dosage strengths of hydrocodone/APAP meeting the FDA's new limits for acetaminophen.
  • A likability study using known "recreational" users has shown that Pisgah's hydrocodone is "un-likable" when inhaled or applied to the mucosa.
  • Pisgah Laboratories has filed fourteen patent applications covering the broad applicability of their technology to hydrocodone and other narcotic products.
  • The company's technology provides an integrated approach to solving three principal concerns: improving patient care, reducing medical practice liability, and reducing barriers for treating pain.

Statistics:

  • Fourteen patent applications covering opioids, anti-depressants, and ADHD medications are currently in various states of prosecution before the US Patent and Trademark Office.
  • Pisgah Laboratories expects to complete clinical trial production and initiate scale-up of its patent-pending hydrocodone product.

Sources:

  • Clinical Trials Week editors, "Pisgah Laboratories Develops Abuse-Deterrent Hydrocodone Product"
  • FDA, "Information by Drug Class: Acetaminophen"
  • NewsRx.com, "Pisgah Labs, Inc. Develops Abuse-Deterrent Hydrocodone Product"