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TheraQuest's Abuse Deterrent Tramadol ER IND for Neuropathic Pain Accepted by FDA
BLUE BELL, PA -- February 6, 2006 -- TheraQuest Biosciences, a development stage pain management company today announced that the FDA has accepted TheraQuest's Investigational New Drug ("IND") application for TQ-1017, its proprietary, abuse deterrent Tramadol Extended Release (ER).
Under the IND, which was submitted for FDA review in late December 2005, TheraQuest will initiate its development program by conducting a pilot Phase I study using its Tramadol ER. The study will evaluate the pharmacokinetics of once-daily Tramadol ER compared to short-acting tramadol (Ultram(R)), which is dosed every four to six hours.
"TheraQuest's Tramadol ER formulation demonstrates excellent dissolution characteristics and has more robust in vitro abuse deterrent properties than either controlled release oxycodone or Tramadol ER formulations marketed in Europe," said Najib Babul, PharmD, President and CEO of TheraQuest. "TQ-1017 was engineered from the outset as a secure-release formulation of once-daily tramadol. As such, recreational drug users cannot easily tamper with it for inhalation or to obtain rapid euphoria from high blood levels," adds Babul.
In 2005, TheraQuest announced that it had been granted 7-years market exclusivity for Tramadol ER by the FDA Office of Orphan Products Development for the management of post-herpetic neuralgia and for the treatment of painful HIV-associated neuropathy.
TheraQuest is funded in part by BioAdvance, the Biotechnology Greenhouse of Southeastern Pennsylvania and Ben Franklin Technology Partners of Southeastern Pennsylvania.
SOURCE: TheraQuest Biosciences, LLC
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