The US Food & Drug Administration (FDA) Office of Orphan Product Development has granted orphan drug designation for Zalicus’s Z160, used for the treatment of pain resulting from shingles.
Biopharmaceutical firm Zalicus said Z160 is an oral, state-dependent, selective N-type calcium channel (Cav 2.2) modulator for postherpetic neuralgia (PHN), a painful neuropathic condition resulting from an outbreak of the herpes zoster virus, also known as shingles.
The orphan designation is reserved for compounds intended at treating conditions, which affect less than 200,000 people in the US and provides tax credits for clinical research costs.
In addition, Zalicus can also apply for annual grant funding, clinical research trial design assistance and waiver of prescription drug user fee act (PDUFA) filing fees.
Earlier this month, Zalicus completed patient enrollment in two Phase II clinical studies of Z160 for chronic neuropathic pain indications, including postherpetic neuralgia and lumbosacral radiculopathy.
Results of both clinical studies are anticipated in the fourth quarter of 2013.
Zalicus president and CEO Mark H N Corrigan said securing orphan drug status for Z160 is an important milestone for the company as it continues the clinical development work required for FDA approval of the drug.
"We look forward to evaluating and reporting the activity of Z160 in chronic neuropathic pain indications later this year, including postherpetic neuralgia and lumbosacral radiculopathy," Corrigan said.
Zalicus said Z160 has demonstrated efficacy in multiple animal models of neuropathic and inflammatory pain, suggesting that it has the potential to treat a broad range of chronic pain conditions.
According to the company, clinical trials in more than 200 subjects have established Z160 as a safe and well tolerated drug candidate.
Image: Earlier in September 2013, Zalicus completed patient enrollment in two Phase II clinical studies of Z160. Photo: courtesy of FreeDigitalPhotos.net.