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Abuse-Deterrent Opioid From Neura Therapeutik Complies With FDA Draft Guidance

1/15/2013 10:06:52 AM

PRINCETON, N.J., Jan. 15, 2013 /PRNewswire/ -- Neura Therapeutik announced today the securing of terms on NL-001, an abuse-deterrent, long-acting opioid analgesic and that studies conducted on NL-001 comply with recent FDA draft guidance. Issued last week, this guidance is intended to assist pharmaceutical companies who wish to develop abuse deterrent opioid formulations.

Prescription opioids 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. 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. Commenting on the abuse crisis, Jeff Gudin, MD, Director Pain and Palliative Care, Englewood Hospital and Medical Center in New Jersey, said, "Achieving a balance between pain control and minimizing the risks of abuse, misuse and diversion is critical to foster better treatment outcomes."

Neura Therapeutik will be completing final pharmacokinetic studies for NL-001, a proprietary abuse-deterrent version of a long-acting opioid. Studies conducted to date demonstrate that Neura's product is less susceptible to manipulation and conforms to FDA's draft guidance.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.

"We commend the FDA for issuing this draft guidance in its efforts to address this serious public health issue," said John La Lota, CEO of Neura Therapeutik. "NL-001 coupled with a comprehensive educational and risk management program would be integral to providing patients with adequate pain management, while attempting to minimize the abuse, misuse and diversion of opioids within the community."

NL-001 is the first in Neura's abuse-deterrent opioid portfolio and is being developed for the U.S. market. NL-001 is expected to be launched in early 2015. Neura is seeking strategic partnerships to advance these products in the US and globally.

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. Neura is divided into two strategic business units:

  • Neura Labs, LLC Focused on the in-licensing and launch of pharmaceutical assets where Neura's development and commercial experience can be leveraged to provide value enrichment through optimal clinical development and commercial advancement.
  • Neura Group, LLC Focused on providing an array of commercial services and management oversight that will optimize the value of market ready/currently marketed assets.

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Media Contact: Greg Gironda
Neura Therapeutik LLC

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SOURCE Neura Therapeutik LLC

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