FDA News

Combination therapy for hypertension, osteoarthritis receives FDA green light

Kitov Pharma announced that a combination of celecoxib and amlodipine besylate for treatment of patients with osteoarthritis pain and hypertension has been approved for marketing by the FDA.

The combination drug (Consensi, Kitov Pharma) includes a nonsteroidal anti-inflammatory drug and an antihypertensive calcium channel blocker, according to a press release from the company. Approved doses of the single-pill combination were based on the current approved doses of celecoxib (200 mg) and amlodipine besylate (2.5 mg, 5 mg and 10 mg).

The approval included results from a phase 3 clinical trial, which showed that the combination drug lowered daytime systolic BP by at least 50% of the reduction in BP achieved in patients treated with amlodipine besylate only (P = .001). A phase 3/4 trial, which not only met the primary endpoint from the previous trial but also showed the combination drug significantly reduced serum creatinine (P = .0005), was also considered in the approval decision, according to the release.

“Over 50 million Americans suffer from osteoarthritis,” Isaac Israel, CEO of Kitov Pharma, said in the release. “About one of three U.S. adults or about 75 million people have high blood pressure, known as the ‘silent killer’ due to the absence of noticeable symptoms. As a result, patients’ adherence to the hypertension treatment regimen is low. We believe that Consensi, as a single-pill combination treatment for osteoarthritis and hypertension, presents a unique value proposition of potentially increasing treatment adherence.”

Disclosure: Israel is an employee of Kitov Pharma.

Kitov Pharma announced that a combination of celecoxib and amlodipine besylate for treatment of patients with osteoarthritis pain and hypertension has been approved for marketing by the FDA.

The combination drug (Consensi, Kitov Pharma) includes a nonsteroidal anti-inflammatory drug and an antihypertensive calcium channel blocker, according to a press release from the company. Approved doses of the single-pill combination were based on the current approved doses of celecoxib (200 mg) and amlodipine besylate (2.5 mg, 5 mg and 10 mg).

The approval included results from a phase 3 clinical trial, which showed that the combination drug lowered daytime systolic BP by at least 50% of the reduction in BP achieved in patients treated with amlodipine besylate only (P = .001). A phase 3/4 trial, which not only met the primary endpoint from the previous trial but also showed the combination drug significantly reduced serum creatinine (P = .0005), was also considered in the approval decision, according to the release.

“Over 50 million Americans suffer from osteoarthritis,” Isaac Israel, CEO of Kitov Pharma, said in the release. “About one of three U.S. adults or about 75 million people have high blood pressure, known as the ‘silent killer’ due to the absence of noticeable symptoms. As a result, patients’ adherence to the hypertension treatment regimen is low. We believe that Consensi, as a single-pill combination treatment for osteoarthritis and hypertension, presents a unique value proposition of potentially increasing treatment adherence.”

Disclosure: Israel is an employee of Kitov Pharma.