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. Kitov determined that the blood pressure reduction synergy seen with combining celecoxib and amlodipine was present in daytime systolic blood pressure – the study’s primary efficacy endpoint. Based on the data, however, the blood pressure reduction synergy was also present with all other blood pressure variables and at all times of day – i.e. daytime diastolic blood pressure, nighttime systolic blood pressure, and nighttime diastolic blood pressure. Although celecoxib, when combined with amlodipine, appears to have a synergistic effect by lowering blood pressure, it lacks this effect when administered by itself.
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. The full clinical study report is expected to be completed in Q2/2018.
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. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of May 31, 2018, to complete its review.
Celebrex® is a registered trademark of G.D. Searle LLC (a subsidiary of Pfizer Inc.). Norvasc® is a registered trademark of Pfizer Inc.