(Reuters)—Kitov Pharmaceuticals Holdings Ltd. said on Tuesday its lead drug, KIT-302, met the main goal of a late-stage study, reducing pain without increasing the risk of heart diseases in patients with osteoarthritis.
Israel-based Kitov says its drug does not need to be labeled with health warnings, but will instead say it reduces the risk of cardiovascular events.
KIT-302 is a combination pill that uses U.S. drugmaker Pfizer’s FDA-approved drugs celecoxib (Celebrex) for pain and amlodipine besylate for hypertension.
No single medication treats both osteoarthritis pain and hypertension and, thus, KIT-302, if approved, will be the only NSAID for use in both conditions, Kitov Chief Medical Officer Paul Waymack tells Reuters.
Data on Tuesday from the late-stage study in 152 patients showed that KIT-302 significantly reduced blood pressure and pain, compared with a placebo, and was also better than the two drugs given separately.
Kitov plans to apply for marketing of the drug in the second half of 2016, and expects to launch it in summer 2017 if approved, Kitov’s Chief Executive Isaac Israel tells Reuters.