dm+d

Unassigned

New Medicines

Consensi Osteoarthritis treatment of pain in patients with hypertension

Information

Consensi
New formulation
Purple Biotech
Burke Therapeutics

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Launched

Dec 20: Kitov has changed its name to Purple Biotech [10].


May 20: Launched in the US [9].


Mar 20: Burke Therapeutics and Coeptis Pharmaceuticals have entered into an agreement where Burke will market the product in the US [8].


Aug 18: Kitov are seeking a commercialisation partner to market Consensi in the US following its approval by the FDA, and intend to expand global marketing further [6].


Oct 17: the NDA for KIT-302 has been accepted by the FDA, Kitov have announced, with a target action date of 31st May 2018 [5].


Dec 16: Kitov announces successful completion of batch stability testing required for submission of a New Drug Application (NDA) to the FDA, and they expect to submit a NDA in the first quarter of 2017 [4].


Dec 15: Kitov plan to submit a New Drug Application for KIT-302 in the 2nd half of 2016 and hope to receive marketing approval in 2017 [2].


Apr 14: Dexcel entered into a strategic agreement with Kitov for the development and manufacture of amlodipine/celecoxib formulation required for submission of a New Drug Application to the FDA [3].

Category

Celecoxib is a selective COX-2 inhibitor used for pain and inflammation while amlodipine is a long-acting calcium channel blocker used to lower blood pressure [2].
OA is one of the most common chronic diseases, with an estimated overall prevalence in the general adult population of 11% for hip OA and 24% for knee OA, respectively. [1] Data are not available for the numbers of pts with OA who suffer with hypertension.
Osteoarthritis treatment of pain in patients with hypertension
Oral

Trial or other data

Dec 15: Regulatory relief was granted by the FDA so Kitov is required to complete two minor trials only after the completion of the pivotal PIII trial. One trial will investigate the drug-drug interaction between celecoxib and amlodipine in 18 healthy volunteers. A second is a pilot pharmacokinetics study in 24 healthy volunteers. The trial will demonstrate that the amlodipine and celecoxib concentrations in the blood in the two formulations of amlodipine/celecoxib are equivalent to the concentrations seen, when the drugs are administered separately [3].


Dec 15: A PIII, double-blind, placebo-controlled trial, indicated that KIT-302 was better at lowering hypertension than amlodipine besylate. The PIII trial (n=150 pts aged 40-65) was designed to assess the effect and safety of celecoxib/amlodipine in pts with osteoarthritis pain and hypertension requiring anti-hypertensive therapy (KIT-302-03-01; EudraCT2013-005381-19; NCT02172040). The primary endpoint was the mean change in average 24 hour ambulatory systolic blood pressure, assessed at baseline and two weeks. The trial studied four groups of 26 to 49 pts in the UK over a two-week period. One group received KIT-302, another group received amlodipine besylate alone, and one was treated with Celebrix alone. A fourth control group received a double placebo. Kitov have reported a successful final outcome though results are awaited [2,3].