Knoll's Tarka Receives FDA Approval

Knoll Pharmaceutical's Tarka, a combination of the ACE inhibitor trandolapril and the calcium channel blocker verapamil, has received US Food and Drug Administration approval.

The product is indicated for the treatment of hypertension as a second-line therapy and is specifically for patients who are unable to control their blood pressure with monotherapy. The two components of Tarka work in a complementary action to lower peripheral resistance, a common cause of hypertension. Physicians will now be able to prescribe Tarka if single-agent therapy is ineffective, and will not have to extend this form of treatment to the point at which side effects are intolerable.

Clinical trials with the product found that it was well-tolerated with minimum side effects of constipation (3.3% of patients), dizziness (3.1%) and coughing (4.6%). Side effects were no greater than noted in patients receiving monotherapy. In addition, Tarka was recorded as having little effect on metabolism, amd therefore could safely be used in diabetic patients, says the company. Tarka will be launched in January 1997 in four different doses.