When was ranexa approved by fda

Recommended initial dosing is mg twice daily; this may be escalated to a maximum dose of mg twice daily, based on disease response. ERICA Study In this placebo controlled study, patients were randomized to receive a 1 week loading regimen of mg Ranexa or placebo twice daily, followed by a 6 week regimen of mg Ranexa or placebo twice daily, in combination with 10 mg amlodipine once daily.

Trial data showed that Ranexa significantly decreased frequency of angina attacks mean 3. The drug was seen to have higher efficacy in male patients. CARISA Study This placebo controlled study enrolled patients, who received one of two twice daily doses of Ranexa mg or mg or placebo, in combination with continued background therapy 50 mg atenolol, 5 mg amlodipine, or mg diltiazem CD.

Both doses significantly reduced angina frequency mg: 2. There was no significant difference in efficacy between the two doses of Ranexa. Adverse events associated with the use of Ranexa may include, but are not limited to, the following:.

Other drugs associated with significant QTc prolongation have been associated with torsades de pointes-type arrhythmias and sudden death. Further, the drug's QTc-prolonging effects are increased in patients with hepatic dysfunction, and in patients on medication which inhibits the metabolic enzyme CYP3A. Ranolazine is contra-indicated for subjects with existing QTc prolongations, in patients with all-grade liver disease and in patients on drugs which inhibit CYP3A including azole antibiotics, macrolide antibiotics, HIV protease inhibitor, and others.

Subjects are advised to monitor symptoms of QTc prolongation closely, in collaboration with their physicians. Ranexa's mechanism of action has not been fully characterized. The drug has been shown to exert its anti-anginal and anti-ischemic effects without reducing heart rate or blood pressue. The drug does not increase the rate-pressure product at maximal exercise levels.

It is suspected that the drug exerts some of its effects by eliciting changes in cardiac metabolism. European Heart Journal Jan;27 1 Epub Sep Abdallah H, Jerling M Effect of hepatic impairment on the multiple-dose pharmacokinetics of ranolazine sustained-release tablets. Published: Jan 30, The approved indication is as follows: Ranexa is indicated for the treatment of chronic angina.

Because Ranexa prolongs the QT interval, it should be reserved for patients who have not achieved an adequate response with other anti-anginal drugs. Ranexa should be used in combination with amlodipine, beta blockers or nitrates.

The effect on angina rate or exercise tolerance appeared to be smaller in women than men. Complete prescribing information for Ranexa, including detailed safety and dosage information, will be available soon at www.

The approval of Ranexa marks the first new pharmaceutical approach to treat angina in more than 20 years in the United States. CV Therapeutics anticipates that Ranexa will be available in pharmacies in late March. Lange, M. Company management will webcast a conference call on Sunday, January 29, , at p.

EST, p. PST, on the company's website.