Neura Therapeutik Addresses FDA Concerns about Abuse, Misuse of Drugs With Development of Safe and Affordable Abuse-Deterrent Opioids
Published: Apr 18, 2013
FLEMINGTON, N.J., April 18, 2013 /PRNewswire/ -- Neura Therapeutik announced today that they will be accelerating the development of their abuse-deterrent brand and generic extended-release opioids. This is in response to the Food and Drug Administration's recent announcement that they will not approve any generic to the original version of OxyContin® extended release oxycodone. The currently marketed version of OxyContin® possesses abuse-deterrent properties which the original version did not; the original version was removed from the market.
Prescription opioids like OxyContin® are a mainstay in the management of moderate-to-severe chronic pain. However, abuse and misuse of these medications have led to a serious public health crisis. The recent FDA announcement cites the benefits of the older, non-abuse-deterrent formulation of the extended-release oxycodone did not outweigh the risks and, therefore, was withdrawn from the market. "We commend the FDA for taking a stance against generic extended-release oxycodone formulations that do not have abuse deterrent properties," said John La Lota, CEO of Neura Therapeutik. "We will be working with the FDA in bringing safe and affordable abuse-deterrent opioids to the market."
Neura Therapeutik is advancing a portfolio of long-acting opioid analgesics designed to prevent the common methods of abuse. Abusers of long-acting opioids seek to defeat the time-release properties of these medications to achieve immediate euphoria. Many long-acting opioids' time-release properties can be defeated by crushing and then ingesting, crushing and then snorting, injecting intravenously after extraction from a tablet or capsule; or co-ingesting with alcohol. Opioids with a reduced abuse liability are the most important unmet need in the development of new long-acting opioids for chronic pain.
Neura Therapeutik will be conducting pharmacokinetic studies for its lead candidates, NL-001 and NL-002, both proprietary abuse-deterrent versions of two currently marketed long-acting opioids. Studies conducted to date demonstrate that Neura's product is less susceptible to manipulation and conforms to FDA's draft guidance. It has physical barriers that prevent chewing, crushing, grating or grinding. Its chemical barriers resist extraction of the opioid using common household solvents or co-ingesting with alcohol. In addition, its key differentiating feature compared to other abuse-deterrent formulations is its ability to retain its extended-release properties even when crushed.
About Neura Therapeutik:
Neura Therapeutik LLC (Neura) is a pain specialty company focused on the commercialization of innovative analgesics that address unmet needs in the marketplace.
Please visit neuratherapeutik.com for more information.
Neura Therapeutik LLC, Greg Gironda, Email, 609-256-1942
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SOURCE Neura Therapeutik LLC