Kitov Pharmaceuticals is announcing that KIT-302, a drug that treats both osteoarthritis (OA) pain and hypertension, has done well in its Phase III, double-blind, placebo-controlled clinical trial. KIT-302 met the primary efficacy endpoint of the trial protocol as approved by the FDA. In addition, KIT-302 was more efficacious at reducing hypertension than the hypertension drug amlodipine besylate. KIT-302 is actually made of both celecoxib (used for OA) and amlodipine besylate.
“We are very pleased with the successful and final outcome of our pivotal Phase III trial and we look forward to meeting with the FDA in the near future to finalize plans for our NDA submission. We believe we will be ready to submit the NDA for KIT-302 in the second half of 2016. Should the NDA [new drug application] meet with the FDA’s approval, we would expect to receive marketing approval in 2017, ” stated Kitov CEO Isaac Israel in the December 15, 2015 news release.
Dr. J. Paul Waymack, chairman of Kitov’s Board and chief medical officer said, “KIT-302 has the potential to address the multi-billion dollar market for the treatment of osteoarthritis pain and hypertension with one drug that reduces patients’ risk of suffering a heart attack or stroke, while also reducing cost for payers. There is currently no single medication on the market that treats both osteoarthritis pain and hypertension and thus, KIT-302 will be the only NSAID indicated both to treat pain and to reduce the risk of heart attack, stroke and death.”
Dr. Waymack told OTW, “NSAIDs are the most widely consumed class of medication, despite having a ‘black box’ warning stating that this class of drugs increases the risk of heart attack, stroke, and death. Kitov’s greatest challenge was to develop an NSAID, which while treating chronic pain, did not increase the risk of these events.”
“The most surprising finding in Kitov’s Phase III study was the fact that instead of impairing amlodipine’s antihypertensive effect, celecoxib enhanced the antihypertensive effect of amlodipine. This synergistic effect contradicted what had been predicted by the world’s medical literature. This literature had previously and repeatedly reported that all NSAIDs impaired the antihypertensive effects of the various classes of blood pressure reducing drugs.”
“As a result of the successful conclusion of Kitov’s Phase III study, as well as prior agreements reached with FDA, by 2017 Kitov anticipates being able to offer to orthopedic surgeons, as well as the rest of the medical community, an NSAID that instead of increasing the risk of heart attack, stroke, and death, will have labeling that states it is indicated to prevent heart attack, stroke, and death, in addition to treating chronic pain.”
