FDA approves Consensi for the treatment of osteoarthritis pain and hypertension.- Kitov Pharma.

Kitov Pharma Ltd.announced that the FDA has approved Consensi (amlodipine and celecoxib) oral tablets for the treatment of osteoarthritis pain and hypertension. The drug is a combination of celecoxib, a non-steroidal anti-inflammatory drug (NSAID), and amlodipine besylate, an antihypertensive calcium channel blocker that has been approved for once daily use in three dosage forms, corresponding to the current approved dosages of amlodipine (2.5, 5, and 10 mg) for the treatment of hypertension and a 200 mg dose of celecoxib for osteoarthritis pain.

The FDA�s approval was based on positive results from the phase III trial that met its primary endpoint. According to the study, the drug lowers daytime systolic blood pressure by at least 50% of the reduction in blood pressure achieved in patients treated with amlodipine besylate only with statistical significance of p=0.001. t has been approved for patients who are appropriate for treatment with amlodipine for hypertension and celecoxib for osteoarthritis.