NEW HAVEN, Conn., March 1, 2016 /PRNewswire/ -- New Haven Pharmaceuticals, Inc. today announced positive study data that shows that DURLAZA™ is well tolerated, with a favorable safety profile comparable to immediate release low dose aspirin and delivers sustained antiplatelet control for a full 24-hour period in high-risk cardiovascular and diabetes patients. These data were highlighted during poster presentations at the Annual American College of Preventive Medicine (ACPM) meeting in Arlington, VA.
The studies, titled, "A New Extended-Release Acetylsalicylic Acid (ASA) Formulation is Well Tolerated: Analysis of 3 Double-Blind Studies" and "Durability of Antiplatelet Effect of a Novel Extended-Release Formulation of Acetylsalicylic acid, DURLAZA, in Patients with Diabetes," were presented by Jeff Patrick, Pharm.D., Chief Scientific Officer at New Haven Pharmaceuticals.
Patrick Fourteau, CEO of New Haven Pharmaceuticals, said, "These positive data show that DURLAZA is well tolerated, and its antiplatelet activity for a full 24-hours provides a significant benefit to patients who have diabetes and cardiovascular disease, by preventing blood clotting, which may cause a secondary heart attack or stroke."
DURLAZA is the first prescription, low dose, extended-release aspirin, (162.5mg), for the secondary prevention of stroke and acute cardiac events, including myocardial infarction (heart attack), in high risk cardiovascular and diabetes patients.
DURLAZA received FDA approval in September 2015. In an open-label, single-center study, high-risk patients with Type II Diabetes (T2DM) with a history of Cardiovascular Disease (or multiple CV risk factors) were treated daily with DURLAZA for 14 days +/- 4 days. The assessment concluded that the new, extended-release orally administered aspirin formulation provided sustained antiplatelet effects over 24 hours in patients with a favorable safety profile.
Low-dose aspirin has been proven to reduce the risk of secondary cardiovascular events and mortality in high-risk patients with stable cardiovascular disease. This is primarily due to aspirin's ability to inhibit platelet aggregation (blood clotting). DURLAZA's 24-hour extended delivery helps maximize the benefit of aspirin by providing consistent platelet inhibition around the clock and the potential for improved patient compliance and adherence to aspirin therapy.
While the body is making platelets 24-hours a day, current immediate-release traditional aspirin only stays in the blood for about a mean duration of four to six hours, with peak plasma concentrations peaking after just 30 minutes. DURLAZA utilizes extended-release, microcapsule technology to prolong aspirin release. DURLAZA offers the only once-daily, 24-hour antiplatelet therapy through the extended release of its 162.5mg dose, resulting in prolonged absorption and sustained platelet exposure to aspirin.
Interested patients should consult with a physician regarding which prescription options are most suitable for their specific needs.
Indication and Important Limitations of Use
DURLAZA (aspirin) Extended Release Capsules 162.5 mg is indicated:
- to reduce the risk of death and myocardial infarction (MI) in patients with chronic coronary artery disease, such as patients with a history of MI or unstable angina pectoris or with chronic stable angina
- to reduce the risk of death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attack
Limitation of use: Use immediate-release aspirin, not DURLAZA in situations where a rapid onset of action of action is required (such as acute treatment of myocardial infarction or before percutaneous coronary intervention).
Important Safety Information
DURLAZA is contraindicated in patients with a hypersensitivity to nonsteroidal anti- inflammatory drugs (NSAIDs) and in patients with the syndrome of asthma, rhinitis, and nasal polyps. DURLAZA may cause severe urticaria, angioedema, or bronchospasm
Warnings and precautions
- DURLAZA increases the risk of bleeding. Risk factors for bleeding include the use of other drugs that increase the risk for bleeding
- Aspirin may cause gastric ulceration and bleeding. Avoid use of aspirin in patients with active peptic ulcer disease
- DURLAZA can cause fetal harm when administered to a pregnant woman, including low birth weight, increased incidence for intracranial hemorrhage in premature infants, stillbirths and neonatal deaths. Avoid DURLAZA in the third trimester of pregnancy
The following adverse reactions have been reported for products containing low dose aspirin:
- Central Nervous System: Agitation, cerebral edema, coma, confusion, dizziness, headache, lethargy, seizures
- Fluid and Electrolyte: Hyperkalemia, metabolic acidosis, respiratory alkalosis
- Gastrointestinal: Dyspepsia, hepatic enzyme elevation, hepatitis, Reye's Syndrome
- Special Senses: Hearing loss, tinnitus
- Renal: Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure
Selected Drug interactions
Do not take DURLAZA 2 hours before or 1 hour after consuming alcohol. Alcohol can interfere with the controlled release properties of DURLAZA
- The concurrent use of DURLAZA with other NSAIDs increases the risk of bleeding and may result in renal impairment
- Coadministration of DURLAZA with renin-angiotensin system (RAS) inhibitors is not recommended in patients who are elderly, volume-depleted, or with compromised renal function as coadministration may lead to deterioration of renal function. Monitor renal function periodically in patients receiving RAS inhibitors and aspirin. NSAIDs may attenuate the antihypertensive effects of RAS inhibitors
- Coadministration of DURLAZA with anticoagulant and antiplatelets may increase the risk of bleeding
- Salicylate can displace protein-bound phenytoin and valproic acid, leading to a decrease in the total concentration of phenytoin and an increase in serum valproic acid levels
- Salicylate can inhibit renal clearance of methotrexate, leading to bone marrow toxicity, especially in the elderly or renal impaired
Please click here for full Prescribing Information for DURLAZA.
About New Haven Pharmaceuticals, Inc.
New Haven Pharmaceuticals, a specialty pharmaceuticals company utilizing proprietary technology developed by Yale University, is dedicated to developing and commercializing innovative drugs to improve the health and quality of patients suffering from serious medical conditions including cardiovascular disease, the world's leading cause of death. DURLAZA, approved by the FDA and now available, is the first and only prescription, low dose, extended-release aspirin, (162.5mg), for the secondary prevention of stroke and acute cardiac events, including myocardial infarction (heart attack), in high risk cardiovascular and diabetes patients.
The Company is also developing additional products incorporating zinc salts, including a proprietary product designed to lower stomach acid in patients suffering from gastro-esophageal reflux disease (or GERD) and a combination product with DURLAZA. For additional information about the Company and DURLAZA, please visit www.newhavenpharma.com.
Dr. Larry Dillaha
New Haven Pharmaceuticals
Executive Vice President,
Joseph T. Schepers
SOURCE New Haven Pharmaceuticals, Inc.