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Trials & Filings

Zalicus Pain Treatment Gets Orphan Designation

FDA recognizes shingles treatment Z160

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Zalicus Inc. has receive Orphan Drug Designation from the FDA for Z160, its first-in-class, oral, state-dependent, selective N-type calcium channel (Cav 2.2) modulator in development for chronic neuropathic pain. The designation covers  management of postherpetic neuralgia, a painful neuropathic condition resulting from an outbreak of the herpes zoster virus, otherwise known as shingles.

Zalicus completed patient enrollment in two Phase II trials of Z160 for chronic neuropathic pain indications, including postherpetic neuralgia and lumbosacral radiculopathy, on September 3, 2013. Top-line results of both studies are expected in the 4Q13.

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