TheraQuest's IND For Abuse Deterrent Strong Opioid (TQ-1015) Accepted By FDA

Main Category: Alcohol / Addiction / Illegal Drugs
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 14 Nov 2008 - 0:00 PDT

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TheraQuest Biosciences, Inc. a development stage pain management company announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug ("IND") application for TQ-1015, its abuse deterrent extended release strong opioid. TQ-1015 is being developed using SECUREL(R), TheraQuest's proprietary abuse deterrent technology.

Najib Babul, PharmD, Chief Executive Officer of TheraQuest stated, "Sustained release opioids are the standard of care for the management of chronic pain. Unfortunately, it is easy to defeat the sustained release mechanim of such dosage forms, making them subject to drug diversion and drug abuse. The TQ-1015 dosage form is highly tamper resistant, when compared to OxyContin(R), thereby minimizing abuse by recreational drug users and drug addicts."

About TQ-1015

TQ-1015 is a once-a-day extended release opioid analgesic for the treatment of chronic pain. It has been developed using TheraQuest's proprietary abuse deterrent extended release drug delivery system (SECUREL(R)). TQ-1015 is significantly more potent than many current oral therapies, including morphine and oxycodone. It shows robust efficacy in various animal models of acute pain, inflammatory pain and neuropathic pain. TQ-1015 will compete in the $8.3 billion U.S. opioid market.

What are Opioids?

For more information on what opioids are, and opioid-induced constipation (OIC), please see:
All About Opioids and Opioid-Induced Constipation (OIC)

About SECUREL(R)

Recent experience with extended release opioid pain relievers has shown that intentional crushing or extraction of the active ingredient from the dosage form by addicts and recreational drug users can destroy the timed-release mechanism and result in a rapid surge of drug into the bloodstream. Serious side-effects and death have been reported from such misuse.

SECUREL(R) is TheraQuest's proprietary abuse deterrent extended release technology for oral abusable drugs. SECUREL(R) dosage forms cannot be easily crushed for inhalation or to obtain rapid euphoria from high blood levels when swallowed. It is also exceedingly difficult for I.V. abusers to extract the active drug from the dosage form using common solvents, including alcohol.

About TheraQuest

TheraQuest Biosciences, Inc. (http://www.theraquestinc.com) is a private, development-stage pain management company building a diversified portfolio of pharmaceutical products to address a critical area of unmet medical need. Despite their limitations, current treatments for acute and chronic pain yield worldwide sales in excess of $30 billion. The TheraQuest team has contributed to the development of numerous analgesics approved in the U.S. over the past 20 years. TheraQuest's strategy is to use its expertise to identify, develop and commercialize product candidates with strong market potential that have lower development costs and reduced regulatory risk than new chemical entities. TheraQuest is headquartered in Blue Bell, Pennsylvania.

TheraQuest is funded in part by BioAdvance, the Biotechnology Greenhouse of Southeastern Pennsylvania and Ben Franklin Technology Partners of Southeastern Pennsylvania.

SECUREL(R) and OxyContin(R) are registered trademarks of TheraQuest Biosciences, Inc., and Purdue Pharma LP., respectively.

TheraQuest Biosciences, Inc.
http://www.theraquestinc.com

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