How long has ranexa been on the market

In addition, Gilead may also be unable to obtain Phase 3 clinical trial results from the studies in the timelines currently anticipated and may need to modify or delay the clinical trials or to perform additional trials.

In addition, Gilead may make a strategic decision to discontinue development of ranolazine for type 2 diabetes if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements.

The reader is cautioned not to rely on these forward-looking statements. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements. Gilead Sciences, Inc. Press Releases. About the TERISA Study TERISA was a randomized, double-blind, placebo-controlled, parallel study designed to evaluate the efficacy of ranolazine in chronic stable angina patients with concurrent type 2 diabetes who remain symptomatic for angina despite receiving a stable dose of one or two concomitant antianginal agents, including beta-blockers, calcium channel blockers or long-acting nitrates.

About Ranexa Ranexa is an extended-release tablet approved as a treatment for chronic angina. Clinical experience did not show an increased risk of proarrhythmia or sudden death. Dosage and administration Begin treatment with mg twice daily and increase to the maximum recommended dose of mg twice daily, based on clinical symptoms.

Swallow tablets whole; do not crush, break, or chew. P-gp inhibitors e. Doses of other sensitive CYP3A substrates e. Drugs transported by P-gp e. About Gilead Sciences Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need.

Forward-Looking Statement This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of , that are subject to risks, uncertainties and other factors, including risks related to the possibility of unfavorable results from other clinical trials involving ranolazine for the treatment of type 2 diabetes.

Source: Gilead Sciences, Inc. 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. Ranexa has been studied in one main study including a total of patients with an average age of 64 years who had had angina pectoris for at least three months. Two doses of Ranexa and 1, mg twice a day were compared with placebo a dummy treatment as an add-on to commonly used medicines for angina pectoris atenolol, amlodipine or diltiazem.

The main measure of effectiveness was how long patients could exercise after 12 weeks of treatment, compared with before treatment. Ranexa has been investigated in one main study involving patients with an average age of 64 years who had had angina pectoris for at least three months. In the study, two doses of Ranexa and 1, mg twice a day were compared with placebo a dummy treatment as an add-on to commonly used medicines for angina pectoris atenolol, amlodipine or diltiazem.

Ranexa was shown to be more effective than placebo at increasing the length of time the patients could exercise. At the start of the study, the patients could exercise for about 7 minutes. After 12 weeks, this increased by an average of 1 minute 56 seconds in the patients adding either dose of Ranexa, and by an average of 1 minute 32 seconds in those adding placebo.

The most common side effects with Ranexa which may affect up to 1 in 10 people are dizziness, headache, constipation, vomiting, nausea feeling sick and weakness. For the full list of side effects of Ranexa, see the package leaflet. Ranexa must not be used in patients who have severe problems with their kidneys or moderate or severe problems with their liver.

It must also not be used in patients who are taking other medicines that are broken down in the same way as ranolazine, or certain other medicines that are used to correct the heart rhythm. For the full list of restrictions, see the package leaflet. The European Medicines Agency noted that the effectiveness of Ranexa in improving the symptoms of patients with stable angina pectoris is modest but that it could be of value in patients who have not responded fully to other medicines.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ranexa have been included in the summary of product characteristics and the package leaflet. As for all medicines, data on the use of Ranexa are continuously monitored. Side effects reported with Ranexa are carefully evaluated and any necessary action taken to protect patients. Ranexa received a marketing authorisation valid throughout the EU on 9 July More detail is available in the summary of product characteristics.