As controversy surrounds the recent FDA decisions concerning abuse deterrent forms of oxycodone drug products, Pisgah Laboratories, Inc. (www.pisgahlabs.com) achieves another technical milestone which may radically alter the landscape for pain medication regulations. Recently, the FDA ruled that the Abbreviated New Drug Applications (ANDAs)—competitive to Purdue Pharma’s branded Oxycodone® would no longer be considered if they did not possess abuse deterrent capability. The announcement’s timing coincided with the day Purdue’s patent for Oxycodone® expired and this regulatory ruling simultaneously delivered a devastating financial blow to would-be generic offerings and a strong message that the government is getting serious about abuse deterrence.
Previous releases by Pisgah Labs have revealed their current product development efforts are directed toward an abuse deterrent hydrocodone / acetaminophen combination product. Interestingly though, the abuse deterrent methodology used to intervene with the potential abuse of the controlled substance, hydrocodone, is also applicable to a variety of other commonly abused narcotics. Of particular interest to Pisgah are the opioid based products almost exclusively used in pain management therapy and the Attention-Deficit Hyperactivity Disorder (ADHD) products such as Ritalin® and Adderall®. It’s no secret that the rampant abuse of pain medications and the ADHD drugs has reached epidemic proportions in the US; it’s also not surprising the FDA has taken strong action to curtail drug abuse activity.
In regard to Pisgah’s product development efforts, the Company’s president, Bill Bristol, stated, “We’re committed to the careful development of abuse deterrent products incorporating our technology to assure our partners of the viability to deliver safe and efficacious medications into the pain and ADHD marketplace”. Pisgah’s technology introduces the abuse deterrent capability at the active ingredient level before it is actually formulated into a dosage presentation, such as a tablet. This approach has been viewed by many as offering additional layers of abuse deterrence by building in the protection from the ground up. Pisgah is also accumulating a number of patent allowances for their novel approach to abuse deterrent pain medications. Bristol added, “As our patents are allowed and issued, the financial component to our product development program provides a sustainable business model for us and to potential marketing partners”.
Pisgah Labs was recently granted a US Patent allowance based on an underlying filing entitled, “Opioid Salts and Formulations Exhibiting Anti-Abuse and Anti-Dumping Properties”. This addition to Pisgah’s patent portfolio covers anti-dose dumping characteristics imparted to oxycodone, hydromorphone, and of course, hydrocodone, through specific salt forms of each active. For those wondering just what dose dumping is and why it is of concern, one should first be aware of the potential consequences to the dose-dumping abuser: often its death. Extended or sustained release pain medications contain sufficient active ingredient to maintain pain relief for twelve, and sometimes, twenty-four hours. This amount of narcotic is considerably more than that found in one immediate release tablet that a patient may take every three to six hours depending on need. However, when the higher dosage product is taken in combination with an alcoholic beverage, a phenomenon known as dose dumping can occur, which releases the entire active ingredient dose quickly—a dose which had been intended to release over a half-day or more. The abuser is seeking the gratifying “high”, but often encounters respiratory and cardio suppression leading to death. Pisgah Labs has identified a means of reducing an active ingredient’s propensity to dose-dump and in so doing, has found another line of defense against drug abuse.