New Haven Pharmaceuticals to Share DURLAZA™ (aspirin) Extended-Release Capsules Study Data At American Heart Association Scientific Sessions Fall Event

News provided by

Nov 02, 2015, 10:30 ET

NEW HAVEN, Conn., Nov. 2, 2015 /PRNewswire/ -- New Haven Pharmaceuticals, Inc. today announced it will present study results regarding antiplatelet effects of its FDA-approved drug DURLAZA™ at the upcoming American Heart Association Scientific Sessions event.

The poster session: "Durability of Antiplatelet Effect of a Novel Extended-Release Formulation of Acetylsalicylic acid, DURLAZA™ in Patients with Diabetes," will be presented by Dr. Paul A. Gurbel at 9 a.m. Tuesday, November 10^th at the Orlando, Fla. conference. For more information on location and full conference schedule, visit www.scientificsessions.org.

In September, New Haven Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) had approved DURLAZA™ 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).

"We are excited that coming on the heels of FDA approval for DURLAZA™ that this study will be presented at the American Heart Association's annual meeting. This presentation represents an important opportunity to share data and other details about DURLAZA™ with the cardiovascular community," said Patrick Fourteau, CEO of New Haven Pharmaceuticals.

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. (www.newhavenpharma.com) 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.

SOURCE New Haven Pharmaceuticals, Inc.