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news.TheraQuest Biosciences' TQ-1017, an abuse deterrent once-daily extended release tramadol for HIV-associated neuropathy, has been granted orphan drug designation by the FDA.
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HIV infection and HIV medications are both associated with the development of neuropathy and neuropathic pain. Symptoms include burning sensations and numbness, which are similar to the neuropathies seen with diabetes. At present, there are no approved drugs available to treat this condition.
“TQ-1017 was engineered from the outset as a secure-release formulation of once-daily tramadol,” said Dr Najib Babul, president and CEO of TheraQuest. “As such, recreational drug users cannot easily tamper with it for inhalation or to obtain rapid euphoria from high blood levels.
“We are particularly pleased to have been granted an orphan drug designation for tramadol,” he continued. “Orphan status affords us 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 for TQ-1017”