Data from Pharmawand - Curated by EPG Health - Date added 08 January 2019

Pain Therapeutics announced two new publications for its drug candidate, Remoxy ER (extended-release oxycodone). The studies are published in Journal of Opioid Management (Vol 14, No 6), a medical journal whose editorial review board consists of the world’s leading experts in the field. Remoxy is the trade name for a new type of abuse-deterrent, twice-daily capsule gel formulation of oxycodone. Remoxy has physical/chemical properties intended to deter abuse.

The first publication is titled “Abuse-Deterrent Properties of Remoxy ER, a High-Viscosity Extended-Release Oxycodone Formulation” and examined the complexity, time and effort needed to extract oxycodone in a lab setting. The publication concludes that Remoxy ER demonstrated robust, meaningful abuse-deterrence relative to OxyContin ER and Xtampza ER. Specifically, in lab simulations of injection abuse, OxyContin ER released 65-87% of its oxycodone within 10 minutes. Xtampza ER released 96% of its oxycodone within 5 minutes in a simple heated manipulation and released 50-60% in two unheated manipulations in 10 minutes. In contrast, a minimal (5-30%) amount of oxycodone was extracted from Remoxy ER in heated or unheated manipulations in 10 minutes, even with the use of multistep manipulations. Additionally, in lab simulations of oral abuse, OxyContin ER released 77-85% of its oxycodone in 5 minutes in four common ingestible liquids. In contrast, manipulated Remoxy ER released 2-22% of its oxycodone in 20 minutes in five common ingestible liquids. Failure of the Remoxy formulation occurred only following a complex combination of manipulation techniques and extraction conditions that require advanced lab equipment.

The second publication is titled “A Nasal Abuse Potential Randomized Clinical Trial of Remoxy ER, a High-Viscosity Extended-Release Oxycodone Formulation” and examined nasal abuse. The publication concludes that Remoxy ER demonstrated significantly lower nasal abuse potential compared to oxycodone immediate-release or OxyContin ER. Specifically, intranasal Remoxy ER led to four-fold lower peak levels of drug (Cmax); a 57-128% longer time to peak levels of drug (Tmax); a >10-fold lower ‘Abuse Quotient’; and lower ‘Take Drug Again’ scores compared to both OxyContin ER and oxycodone IR. Data from both studies were included in the New Drug Application (NDA) for Remoxy.

Despite these robust data, and a total of over 8,800 meaningful data points, in August 2018 the FDA issued a Complete Response Letter (CRL) for Remoxy. Pain Therapeutics disagrees with recent FDA comments and conclusions regardingRemoxy's abuse-deterrent properties.

A meeting will be held with the FDA on January 31st to discuss this matter.

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