According to the FDA, Tramadol extended release (ER) was designated a fast track product both because of the seriousness of painful HIV-associated neuropathy and because the treatment demonstrates the potential to provide a therapeutic benefit. There are currently no approved therapies for patients with painful HIV- associated neuropathy.
Fast track designation provides expedited regulatory review; TheraQuest is now eligible to submit an application for Tramadol ER on a rolling basis rather than making the full submission in one go.
“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 Dr Najib Babul, CEO of TheraQuest.
Tramadol ER (TQ-1017) is an extended release once-daily abuse deterrent formulation of tramadol. According to TheraQuest, it demonstrates more robust in vitro abuse deterrent properties than either controlled release oxycodone or marketed Tramadol ER formulations.
The treatment has already been granted orphan drug status providing TheraQuest with seven years of market exclusivity in both HIV-associated neuropathy and a further designation, post-herpetic neuralgia.