TheraQuest Biosciences, a development stage pain management company, has been granted a second Orphan Drug Designation for TQ-1017, its abuse deterrent once-daily extended release tramadol for the management of postherpetic neuralgia by the FDA Office of Orphan Products Development.

Postherpetic neuralgia (PHN) is a chronic, debilitating neuropathic pain syndrome that occurs as a complication of shingles or herpes zoster infection. The pain of PHN is unrelenting and is often described as burning, stabbing or aching. According to

Topical lidocaine patch (Lidoderm), gabapentin (Neurontin) and pregabalin (Lyrica) are the only approved treatments for postherpetic neuralgia. Tramadol's pain relieving effects are due to multiple mechanisms of action, including serotonin and norepinephrine reuptake inhibition and opioid receptor activation. The current consensus is that multimodal analgesic therapy may be necessary to exploit the benefits of drugs with different mechanisms of action, said a company release.

Najib Babul, CEO of TheraQuest stated "New, long-acting formulations of tramadol in development are designed to gradually release their much larger tramadol content over a 24-hour period. TQ-1017 was engineered from the outset as a secure-release formulation of once-daily tramadol. It cannot be easily crushed for inhalation or to obtain rapid euphoria from high blood levels when swallowed. It is also difficult to extract tramadol from our once-daily formulation using common solvents, including alcohol. TheraQuest believes that these features may provide a greater margin of safety in the event of intentional or inadvertent attempts to defeat the timed release mechanism".