PODRAS

PODRAS

Paradoxical Technology Designed to Prevent Overdose and Abuse

PODRAS (Paradoxical Overdose Resistance Activating System) deliberately regulates the bioavailability of active ingredients in both generic and non-generic medications in a way that reduces the opportunity for overdose and/or abuse.

More Becomes Less

Our PODRAS™ delivery technology is designed to prevent overdose when more pills than prescribed are swallowed intact. Preclinical studies of prototypes of oxycodone with PODRAS technology suggest that, unlike other third-party abuse-deterrent oxycodone products in the marketplace, if more tablets than prescribed are deliberately or inadvertently swallowed, the amount of drug active released over 24 hours may be substantially less than expected. However, if the prescribed number of pills is swallowed, the drug release should be as expected. We are currently working on an alternate Oxycodone hydrochloride ER product candidate incorporating our PODRAS™ delivery technology. In April 2015, the FDA published Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling, which cited the need for more efficacious abuse-deterrence technology. In this Guidance, the FDA stated, "opioid products are often manipulated for purposes of abuse by different routes of administration or to defeat extended-release properties, most abuse-deterrent technologies developed to date are intended to make manipulation more difficult or to make abuse of the manipulated product less attractive or less rewarding. It should be noted that these technologies have not yet proven successful at deterring the most common form of abuse-swallowing a number of intact capsules or tablets to achieve a feeling of euphoria." The FDA reviewed our request for Fast Track designation for our abuse deterrent Oxycodone hydrochloride ER (formerly referred to as Rexista™) development program incorporating PODRAS™, and in May 2015 notified us that the FDA had concluded that we met the criteria for Fast Track designation. Fast Track is a designation assigned by the FDA in response to an applicant's request which meets FDA criteria. The designation mandates the FDA to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. This could potentially result in accelerated approval for Oxycodone hydrochloride ER incorporating PODRAS™, thereby making it available to patients earlier than would be traditionally possible.

Our innovative pharmacokinetic delivery system responds to an overdose with an inversely proportional release ratio, rapidly reducing the body's ability to uptake the active ingredients. Put succinctly, the more tablets swallowed intact, the less medication is released over a 24-hour period. Conversely, if the medication is taken as prescribed, the drug release should be as expected.

How It Works

Abuse Deterrent Delivery

The PODRAS abuse deterrent system discourages abuse in a number of different ways.

Abuse Prevention and Deterrence

Should the Company be successful in demonstrating that PODRAS™ works in humans, then the intention is to apply PODRAS™ to Oxycodone hydrochloride ER. Oxycodone hydrochloride ER contains a number of abuse-deterrent attributes. A non-toxic blue dye is released only if the pill is tampered with. This dye is readily apparent on the mouth, nose and hands of anyone who tries to abuse the drug, and may serve as an early warning mechanism. Oxycodone hydrochloride ER also contains an irritant that causes irritation when snorted to inhibit abuse. Once hydrated, our abuse-deterrent technology makes the drug viscous, sticky and difficult to introduce into a syringe. Alcohol dose dumping, which is often used as a catalyst to enable the premature and exaggerated release of a drug, is prevented by inhibiting dose-dumping above the prescribed dose. Oxycodone hydrochloride ER is also difficult to abuse via inhaling or using conventional heat extraction methods.

Partnership Opportunities

With the help of our partners, we apply our proprietary delivery platform technologies and expertise in pharmaceutics, drug delivery and drug manufacture with the goal of minimizing the risk, time and manufacturing cost of bringing the finished product to market.

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Product Pipeline

See our technology in action. Our product portfolio includes both new products, which follow a New Drug Application (NDA) 505(b)(2) FDA regulatory pathway, and controlled-release generic products, which follow an Abbreviated New Drug Application (ANDA) pathway.

View Product Pipeline