DARA BioSciences submits KRN5500 Orphan Drug Application with FDA

DARA BioSciences, Inc. (NASDAQ: DARA), a specialty pharmaceutical company focused on oncology and oncology supportive care products, announced today it has submitted an Orphan Drug Application to the U.S. Food and Drug Administration (FDA) for KRN5500, a compound in development to treat a painful form of chronic chemotherapy-induced peripheral neuropathy (CCIPN). The FDA provides orphan drug status to products that treat rare conditions for which there may be few adequate therapies. No approved treatments currently exist for CCIPN. Orphan designation qualifies the drug developer for tax credits, the waiver of the prescription drug user fee and seven-year market exclusivity. DARA engaged consultants with extensive FDA experience to guide the preparation of the Orphan Drug Application.

In October 2011, the FDA designated KRN5500 a "Fast Track" drug. The Fast Track process expedites the development and review of drugs that treat serious diseases and fill an unmet medical need. Fast track designation may support accelerated approval of such drugs, and orphan designation would provide seven year exclusivity on KRN5500 for the orphan indication.

KRN5500 is an intravenously administered, non-opioid analgesic with rapid onset of action and prolonged pain mitigation, as demonstrated in both pre-clinical and clinical studies. KRN5500 is being developed to treat the painful form of CCIPN. Painful CCIPN is characterized by the persistence of chemotherapy-associated pain for at least twelve weeks after chemotherapy has stopped.

Peripheral neuropathy is caused by nerve damage, a potential complication of treatment with platins, taxanes and other cancer drugs. The disorder comprises numbness and tingling of the arms and legs, including hands and feet. A subset of these patients develops a chronic, painful form of the condition. The pain can be extreme and continuous, and can be elicited by stimuli such as touch and cold, which do not normally elicit a pain response. Painful CCIPN interferes with activities of daily living and significantly reduces the quality of life of cancer patients. Since CCIPN has no current approved therapies, KRN5500 addresses a significant unmet medical need, especially since people with cancer are living longer due to improved treatments and therapies.

DARA CEO, David J. Drutz, MD, stated, "Painful CCIPN can be truly debilitating. Taking just a single step can cause tremendous pain. Currently, clinicians treat CCIPN with a number of prescription medications, botanicals and dietary supplements. However, none has been proven effective in placebo-controlled clinical trials. In fact, several large trials testing many of these products have failed to demonstrate any efficacy when compared to placebo. Conversely, KRN5500 demonstrated statistical and clinical superiority over placebo in a small Phase 2a clinical trial conducted in patients that had both advanced cancer and the painful form of CCIPN. It is important to note that each of the trial participants was also prescribed other pain medications, none of which alone or in combination had resulted in a reduction of pain due to CCIPN."

Given the promising results from its Phase 2a trial, DARA is currently seeking potential development partners, with the intention of initiating a Phase 2b trial for KRN5500 in 2013 once collaboration has been established.

In addition to seeking orphan designation, DARA has simplified the formulation of KRN5500 to make it easier to administer at the bedside. Instead of requiring a two-step mixing process, the new formulation is a solution that can be added directly to an IV bag. DARA has filed new patents for this formulation and has established a drug supply chain to support future clinical trials."

"KRN5500 fits well within DARA's portfolio of cancer support products," Dr. Drutz continued. "Cancer supportive care is an underserved area with unmet medical needs, as CCIPN illustrates. DARA's mission is to bring therapies to oncology patients beyond those specifically directed to the treatment of their cancer."