DARA BioSciences, Inc. 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.
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