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FDA Approves Consensi for Osteoarthritis Pain

FirstWord Pharma news release; 2018 May 31

Kitov Pharma Ltd. recently announced that the US Food and Drug Administration (FDA) has approved Consensi (amlodipine and celecoxib) oral tablets for the treatment of osteoarthritis pain and hypertension. Kitov Pharma Ltd. is headquartered in Tel Aviv, Israel.

Indications: Consensi is a patent-protected combination of celecoxib, a non-steroidal anti-inflammatory drug (NSAID) for the treatment of osteoarthritis pain, and amlodipine besylate, an antihypertensive calcium channel blocker for the treatment of hypertension.

Dosage/administration: Consensi was approved for once daily use in 3 dosage forms, corresponding to the current approved dosages of amlodipine (2.5, 5, and 10 mg) for hypertension and a 200 mg dose of celecoxib for the treatment of osteoarthritis pain.

Adverse reactions: Most common adverse reactions to celecoxib in arthritis trials (>2% and

>placebo) were abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema,

accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper respiratory

tract infection, and rash. Most common adverse reaction to amlodipine is edema which occurred in a dose-related manner. Other adverse experiences to amlodipine that were not

dose-related but that were reported with an incidence >1.0% are fatigue, nausea, abdominal pain, and somnolence.


FDA approves Kitov’s Consensi for treatment of osteoarthritis pain and hypertension. [news release]. Tel Aviv, Israel: Kitov Pharma Ltd. May 31, 2018. Accessed June 14, 2018.