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 unintentionaldose dumping.

Product Pipeline

Product US Market Size Indication Clinical/BE Studies FDA Filed FDA Approved
Oxycodone hydrochloride ER $1.36B* Pain Phase complete Phase in progress Phase not started

Source:Represents sales for all strengths, unless otherwise noted, for the 12 months ended May 2019 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

  • ANDA Candidates

    • 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

MulticolumnaDifferentiated 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.

  • 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.