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June 17, 2014

DARA BioSciences receives FDA orphan drug designation for KRN5500

DARA BioSciences has received orphan drug designation from the US Food and Drug Administration's (FDA) Office of Orphan Products Development for KRN5500, for treating multiple myeloma.

By admin-demo

DARA BioSciences has received orphan drug designation from the US Food and Drug Administration’s (FDA) Office of Orphan Products Development for KRN5500, for treating multiple myeloma.

Multiple myeloma is a hematologic cancer or cancer of the blood.

KRN5500 is a non-opioid, non-narcotic compound that is currently being tested in Phase I clinical trial.

Earlier this year, KRN5500 received orphan status to be developed for the parenteral treatment of painful, chronic, chemotherapy-induced peripheral neuropathy (CCIPN) that is refractory to conventional analgesics in patients with cancer.

"We believe this myeloma-specific orphan designation enhances both the viability and the future market opportunity for this valuable pipeline product."

DARA BioSciences MD, CEO and chief medical officer David J Drutz said: "It is noteworthy in this regard that up to 20% of myeloma patients have intrinsic peripheral neuropathy, an incidence that increases to the range of 75% in patients treated with neurotoxic drugs such as thalidomide or bortezomib.

"We believe this myeloma-specific orphan designation enhances both the viability and the future market opportunity for this valuable pipeline product."

In 2011, the drug also received FDA grant as a fast-track programme that expedites the development pathway and consideration for priority review.

Orphan drug designation will allow DARA to market the product for seven years, starting from the time of approval, tax credits, and the waiver of PDUFA filing fees, and access to federal grants.

"This second orphan drug designation underscores the value of this asset and strengthens DARA’s resolve and positioning in the ongoing pursuit of partnering opportunities to assist in funding the clinical advancement and development pathway of KRN5500," Drutz added.

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