New Haven Pharmaceuticals: Study Shows DURLAZA (aspirin) Extended-Release Capsules Delivers Sustained Antiplatelet Effects For Full 24 hours

New Data Presented at American Heart Association’s Scientific Sessions

New Haven Pharmaceuticals, Inc. recently announced new study data that shows the company’s FDA-approved drug DURLAZA delivers sustained antiplatelet control for a full 24-hour period in high-risk patients.

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).

The data was released during a poster presentation at the American Heart Association’s Scientific Sessions event in Orlando, Fla. The study, entitled “Durability of Antiplatelet Effect of a Novel Extended-Release Formulation of Acetylsalicylic acid, DURLAZA, in Patients with Diabetes,” was presented by Dr. Paul A. Gurbel.

Low-dose aspirin has been proven to reduce the risk of secondary cardiovascular events and mortality in high-risk patients with stable cardiovascular (CV) disease. This result is primarily due to aspirin’s ability to inhibit platelet aggregation (blood clotting). DURLAZA utilizes extended-release, microcapsule technology to prolong aspirin release.

“Patients with diabetes and CV disease often demonstrate high platelet turnover and high on-treatment platelet reactivity and experience increased rates of secondary CV events. The DURATION trial was the first study to characterize the durability of platelet inhibition from DURLAZA (162.5mg), the first extended-release, low-dose aspirin, in this prothrombotic patient population. The primary endpoint of this study was the change in platelet aggregation between 1 hour and 24 hours post-dosing. In the DURATION study, there was no change in mean platelet aggregation at any time in that 23 hour time interval following dosing of (162.5mg) DURLAZA. These data demonstrate the maintenance of stable platelet inhibition over the entire 24 hour dosing interval,” said Paul Gurbel, MD, Director of the Inova Center for Thrombosis Research and Drug Development and Director of Interventional Cardiology and Cardiovascular Medicine Research at Inova Heart and Vascular Institute, Professor of Medicine, Johns Hopkins University, Adjunct Professor of Medicine, Duke University.

In an open-label, single-center study, high-risk patients with type II diabetes (T2DM) with a history of CV 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.

“As a preventive cardiologist and lipid specialist I continually seek improvements in our ability to reduce coronary interventions and hopefully ultimately eradicate the more serious vascular outcomes, stroke and heart attack. Though we have made dramatic strides in lipid management, an enormous unmet need remains, as reflected by unacceptably high residual risk in those who have already experienced an Artherosclerotic Cardiovascular Disease (ASCVD) event. Now with Durlaza I believe we have made a consequential leap in our approach to thrombosis, a key contributor to stroke and heart attack. We know that immediate release aspirin has an unacceptably short half-life of approximately 20 minutes; enabling many of the 4 billion platelets the average human produces hourly to remain fully capable of forming dangerous clots. Certain populations such as those with underlying vascular disease and diabetic patients are known to have even higher platelet production rates, making them even more prone to persistent platelet-induced thrombotic vulnerability. As the Duration study demonstrated in patients with diabetes, Durlaza addresses this issue through its novel release system. DURLAZA (162.5 mg) daily doses produce smoother and more prolonged anti-platelet effects. Durlaza has been approved for use in secondary prevention, and I will surely take advantage of this simple yet remarkable opportunity to better control a prominent risk in my ASCVD patients,” said Seth J. Baum, MD, FACC, FACPM, FAHA, FNLA, Preventive and Integrative Cardiology, Medical Director, Women’s Preventive Cardiology, Christine E. Lynn, Women’s Health & Wellness Institute, Boca Raton Regional Hospital, CMO, MB Clinical Research.

DURLAZA offers the only once-daily antiplatelet therapy through the extended release of its (162.5mg) dose, resulting in prolonged absorption, andsustained platelet exposure to aspirin.

The company expects market availability in early 2016.

About DURLAZA
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 is required (such as acute treatment of myocardial infarction or before percutaneous coronary intervention).

Important Safety Information
Contraindications
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

Adverse reactions
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

About New Haven Pharmaceuticals, Inc.
New Haven Pharmaceuticals Inc. is a specialty pharmaceuticals company developing new prescription drug products that utilize currently marketed drugs or generally recognized as safe (GRAS) active pharmaceutical ingredients (APIs) for use in therapeutic applications representing attractive market opportunities. In addition to FDA-approved DURLAZA, New Haven Pharmaceuticals is developing products incorporating proprietary Yale University technology utilizing zinc salts, including both a proprietary zinc salts product designed to lower stomach acid in patients suffering from gastro-esophageal reflux disease (or GERD) and a combination product with DURLAZA. For more information, visit www.newhavenpharma.com.