Pharmaceutical Business review

Phase III trial shows positive results for Cleviprex

Cleviprex is a novel investigational IV antihypertensive for the treatment of acute hypertension when the use of oral therapy is not feasible or desirable.

Among patients treated in the trial with Cleviprex, which is administered by intravenous (IV) infusion, target blood pressure levels were reached by a median of 10.9 minutes, with 89% (104 of 117) of patients achieving their target within 30 minutes. Following initial blood pressure control, Cleviprex was infused continuously for a median of 21 hours to maintain blood pressure within target limits. Among patients who received 18 hours of continuous Cleviprex therapy, 92% (108 of 117) did not require the addition of other IV antihypertensive agents during the 18-hour period.

Joseph Varon, clinical professor of medicine, University of Texas Health Science Center and St. Luke’s Episcopal Hospital, Houston, said: “The rapid control achieved with Cleviprex in this study is an important finding because every minute counts when treating acute hypertension. Maintaining target blood pressure can prevent potentially irreversible damage to the brain, heart, kidneys or blood vessels. And our finding that continuous infusion of Cleviprex for a median of 21 hours maintained the target blood pressure is also important, because some patients require prolonged treatment with an IV agent to keep their blood pressure under control.”

John Kelley, president and COO of Medicines, said: “Current agents for the treatment of acute hypertension have various shortcomings, and there have been no new therapies in 10 years. There is a clear need for new and better IV antihypertensive agents that provide rapid, predictable and sustained blood pressure control, and we believe Cleviprex can meet that need.”