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.
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
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.