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TheraQuest receives 2nd Orphan Drug status for neuralgia drug



13th August,2005:TheraQuest Biosciences announced that the FDA Office of Orphan Products Development has granted a second Orphan Drug Designation for TQ-1017, its abuse deterrent once-daily extended release tramadol for the management of postherpetic neuralgia.

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.

In addition to persistent pain, patients with PHN experience episodic pain due to abnormal sensations from normal daily activities such as putting on a shirt or contact with a cool gentle breeze. If untreated, postherpetic neuralgia can adversely affect a patient’s quality of life. Patients frequently fail to obtain complete pain relief with existing treatments or develop troublesome side effects, the company said in a news release.

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.

The 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 the once-daily formulation using common solvents, including alcohol, the release noted.

TheraQuest Biosciences is a development-stage pain management company . Despite their limitations, current treatments for acute and chronic pain yield worldwide sales in excess of $25 billion. The TheraQuest team has contributed to the development of numerous analgesics approved in the U.S. over the past 20 years. TheraQuest’s strategy is to use its expertise to identify, develop and commercialize product candidates with strong market potential that have lower development costs and reduced regulatory risk than new chemical entities. TheraQuest is headquartered in Blue Bell, Pennsylvania.

TheraQuest is funded in part by BioAdvance, the Biotechnology Greenhouse of Southeastern Pennsylvania and Ben Franklin Technology Partners of Southeastern Pennsylvania.

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