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FDA Grants Fast Track Designation on Tramadol ER in Painful HIV-associated Neuropathy
Fast Track designation provides expedited regulatory review for new drugs demonstrating potential to address unmet medical needs for the treatment of serious or life-threatening conditions. Under Fast Track, TheraQuest is now eligible to submit a new drug application (NDA) for Tramadol ER on a rolling basis, allowing the FDA to review sections of the NDA in advance of receiving TheraQuest's full submission.
According to the FDA, Tramadol ER was designated a Fast Track product both because of the seriousness of painful HIV-associated neuropathy and because Tramadol ER demonstrates the potential to provide a therapeutic benefit. There are currently no approved therapies for patients with painful HIV- associated neuropathy.
"Tramadol ER's fast track status underscores the urgency of developing new treatments for patients with painful HIV-associated neuropathy and the potential of Tramadol ER to improve the quality of life of patients with this devastating disease," said Najib Babul, PharmD, President and CEO of TheraQuest. "We look forward to working closely with the Division of Anesthetic, Analgesic and Rheumatology Products at FDA to expedite the development of Tramadol ER for painful HIV-associated neuropathy," added Babul.
About Tramadol ER (TQ-1017)
TheraQuest's Tramadol ER (TQ-1017) is a proprietary, extended release once-daily abuse deterrent formulation of tramadol. It demonstrates more robust in vitro abuse deterrent properties than either controlled release oxycodone or marketed Tramadol ER formulations. It is exceedingly difficult to extract the active drug from the formulation using common solvents. It also cannot be crushed for inhalation to obtain rapid euphoria. Without a secure release once-daily tramadol, rapid absorption from intentional or inadvertent crushing has the potential to deliver a massive dose all at once and produce neurological toxicity, including agitation, seizures, coma and respiratory failure.
TheraQuest has 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." Orphan product designation provides seven years of market exclusivity, 50% R&D Tax Credits, exemption from FDA Prescription Drug User Fee and access to research grants from the Office of Orphan Products Development.
TheraQuest has an open IND in the United States and has recently completed a Phase I study evaluating the pharmacokinetics of once-daily Tramadol ER compared to short-acting tramadol (Ultram(R)), which is dosed every four to six hours.
Source: TheraQuest Biosciences, LLC