Consensi™ is a combination drug that is indicated for the treatment of osteoarthritis (OA) pain and hypertension simultaneously. Consensi™ is comprised of two FDA-approved drugs, celecoxib (the active ingredient in Pfizer’s Celebrex®) for the treatment of pain caused by OA, and amlodipine besylate (the active ingredient in Pfizer’s Norvasc®), a drug designed to treat hypertension.
In December 2015, Kitov announced that the Phase III clinical trial for Consensi™ successfully met its primary efficacy endpoint of the trial protocol as approved by the U.S. Food & Drug Administration (FDA). The trial’s primary efficacy endpoint was to show that Consensi™ lowers daytime systolic blood pressure by at least 50% of that achieved in patients treated only with amlodipine. The trial data, in fact, revealed that Consensi™ was more efficacious at reducing blood pressure than when amlodipine was used on its own.
The trial data also showed that the favorable blood pressure effects of Consensi™ were present in all blood pressure variables measured in the study.
These results not only confirm the study’s top-line findings, but also reveal that using a combination drug for treating pain can improve patient health.
Additional data from the Phase III clinical trial of Consensi™ suggested beneficial effects on renal (kidney) function. The data also suggested that Consensi™ may protect against the amlodipine side effect of causing fluid retention by the kidneys.
Therefore, Kitov conducted a Phase III/IV clinical trial in the second half of 2017. The trial’s top-line results, which were announced in October 2017, not only validated the top-line results of the Phase III trial, but also showed that Consensi™ improves renal function.
Kitov submitted a New Drug Application (NDA) in July 2017. The U.S. Food & Drug Administration (FDA) filed the NDA in September 2017, thereby accepting it for a full review, and approved Consensi™ oral tablets for marketing on May 31, 2018.
Kitov announced in January 2019 the signing of an exclusive marketing and distribution agreement with Coeptis Pharmaceuticals for commercialization of Consensi™ in the US market. Part of Kitov’s worldwide commercialization plans for Consensi™, the agreement is Kitov’s third licensing and distribution agreement, following previously signed deals covering China and South Korea. Kitov is currently evaluating additional commercialization agreements in major markets worldwide
Celebrex® is a registered trademark of G.D. Searle LLC (a subsidiary of Pfizer Inc.). Norvasc® is a registered trademark of Pfizer Inc.