Oxycodone hydrochloride ER

Oxycodone hydrochloride ER

Potential Best-in-Class Oxycodone Product

One of our key non-generic development products is Oxycodone hydrochloride ER, an abuse- and alcohol-resistant, controlled-release oral oxycodone formulation. Oxycodone hydrochloride ER is designed to discourage common methods of tampering associated with misuse and abuse of prescription opioid analgesics. Oxycodone hydrochloride ER provides deterrence against intentional (drug abuse) and unintentional dose dumping.

Product Pipeline

Product Brand US Sales Indication Clinical/BE Studies FDA Filed FDA Approved
NDA
Oxycodone hydrochloride ER OxyContin® $1.94B* Pain
Clinical/BE Studies Phase complete
FDA Filed Phase in progress
FDA Approved Phase not started

Source: Represents sales for all strengths, unless otherwise noted, for the 12 months ended August 2017 in the US., including sales of generics in TRx MBS Dollars, which represents projected new and refilled prescriptions representing a standardized dollar metric based on manufacturer’s published catalog or list prices to wholesalers, and does not represent actual transaction prices and does not include prompt pay or other discounts, rebates or reductions in price. Source: Symphony Health Solutions Corporation. The information attributed to Symphony Health Solutions Corporation herein is provided as is, and Symphony makes no representation and/or warranty of any kind, including but not limited to, the accuracy and/or completeness of such information.

Physico-chemical clinical studies suggests

  • Should be difficult to abuse through crushing, chewing or licking

  • Release of oxycodone is likely to be slower or not instantaneous in a range of beverages and solvents

  • Should not "dose dump", or instantaneously release the entire dose of oxycodone, in the presence of ethanol (alcohol) over a range of concentrations

  • When pulverized and reduced to particles, should be difficult and time consuming to syringe or inject in the form and volume suitable for intravenous administration

  • When pulverized or reduced to particles, contains an irritant which should make it difficult or inefficient to snort or inhale

  • Release of oxycodone should be insignificant or inefficient via heating and vaporization

  • Extraction of oxycodone which has been microwaved should be difficult or inefficient

  • Contains a blue dye that is emitted once the tablet is tampered with or crushed. This blue dye may act as a deterrent or early warning mechanism if abused orally or via the intra-nasal route

  • Oxycodone hydrochloride ER has No Food Effect, can be taken with or without a meal, unlike many opioids currently on the market

Phase I Clinical Trial Results

In January 2016, we announced that pivotal bioequivalence trials of our Oxycodone hydrochloride ER, dosed under fasted and fed conditions, had demonstrated bioequivalence to OxyContin® (oxycodone hydrochloride) extended release tablets. The study design was based on FDA recommendations and compared the lowest and highest strengths of exhibit batches of our Oxycodone hydrochloride ER to the same strengths of OxyContin®. The results show that the ratios of the pharmacokinetic metrics, Cmax, AUC 0-t and AUC 0-f for Oxycodone hydrochloride ER vs OxyContin®, are within the interval of 80% - 125% required by the FDA with a confidence level exceeding 90%. Having demonstrated such bioequivalence, we will not be required to conduct Phase III studies for Oxycodone hydrochloride ER. The FDA notification is significant as it provides a basis for an accelerated development plan for our Oxycodone hydrochloride ER.

These results demonstrate that the bioavailability of a single dose of our Oxycodone hydrochloride ER oxycodone was equivalent to that of OxyContin®, as measured by the respective areas under the curve (AUC).

This indicates that the technology platform in our formulation of our Oxycodone hydrochloride ER, the point of divergence drug delivery system in nPODDDS™ does not interfere with the bioavailability of oxycodone.

Differentiated from Current Commercial Products

We believe that our Oxycodone hydrochloride ER oxycodone is also sufficiently differentiated from currently available commercial oxycodone hydrochloride extended-release products. Our nPODDDS technology allows Oxycodone hydrochloride ER to provide a quick onset of action, followed by a sustained release rate, designed to potentially retard tampering without interfering with the bioavailability of the product. In addition to being bioequivalent to OxyContin®, our Oxycodone hydrochloride ER contains a blue dye which is released if abused or tampered with. This dye can potentially serve as an early warning mechanism to flag abuse or misuse of the opioid.

No Food Effect

Following an FDA requested food effect study, our Oxycodone hydrochloride ER showed that it can be administered with or without a meal (i.e., no food effect). The lack of a food effect is a critical safety dimension, that further differentiates our Oxycodone hydrochloride ER from currently marketed oral oxycodone extended release products.

The study design was a randomized, one-treatment two periods, two sequences, crossover, open label, laboratory-blind bioavailability study for our Oxycodone hydrochloride ER following a single 80 mg oral dose to healthy adults under fasting and fed conditions.

According to Symphony Health Solutions, OxyContin® (oxycodone hydrochloride controlled-release tablets) had estimated U.S. sales of approximately US$1.94 billion for the 12 months ending August 2017 (TRx MBS Dollars).

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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