DARA BioSciences‘s (NASDAQ:DARA) investigational pain treatment for cancer patients now has fast-track status from the U.S. Food and Drug Administration.
The compound KRN5500 is being developed with the National Cancer Institute to treat neuropathic pain brought on by chemotherapy. The FDA’s fast-track program is intended to facilitate development and speed regulatory review of new drugs that treat serious conditions and address unmet medical needs.
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Raleigh, North Carolina-based DARA says estimates show that between 40 percent and 50 percent of cancer patients receiving chemotherapy suffer from chemotherapy-induced neuropathy, or CIPN. The pain is caused by damage to peripheral nerves from the chemotherapeutics that travel throughout the body. The pain typically starts in the feet and hands, and progresses as cancer treatment continues.
With fast-track status, DARA can submit data to the FDA in parts rather than waiting to complete an entire New Drug Application. The company may also receive more frequent meetings with regulators. This type of review could save time and speed development. The idea is that the sooner a company hears answers from the FDA, the more quickly it can respond and move forward developing the compound.
DARA has completed one phase 2 trial on KRN5500. The company plans to start a second phase 2 study later this year in partnership with the National Cancer Institute, which is financing the study.
DARA does not yet have any FDA-approved drugs. The company’s drug pipeline includes another compound, DB959, being developed as a new type 2 diabetes treatment. That compound is still in early stage clinical development.
