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www.fdanews.com/articles/174609-kitov-reports-positive-results-in-phase-3-trial-for-osteoarthritis-candidate

Kitov Reports Positive Results in Phase 3 Trial for Osteoarthritis Candidate

December 21, 2015

After raising $13 million in an initial public offering last month, Tel Aviv-based Kitov Pharmaceuticals reported positive Phase 3 results for its candidate that aims to ease osteoarthritis pain while keeping a patient’s blood pressure in check.

In the 152-patient study, KIT-302 was more effective at reducing hypertension than amlodipine besylate, one of its components, alone. KIT-302 is a combination of two off-patent drugs — Pfizer’s Celebrex (celecoxib) for osteoarthritis and amlodipine besylate for hypertension. The brand version of amlodipine besylate is Pfizer’s Norvasc.

In light of the study results, Kitov plans to submit an NDA for approval next year. It would be the first single medication to treat both osteoarthritis pain and hypertension, a side effect of nonsteroidal anti-inflammatory drugs like Celebrex.