New Haven Pharmaceuticals Announces Availability of DURLAZA™, First and Only Once-Daily 24-Hour Aspirin

Low-Dose Extended Release Capsules Deliver Sustained Anti-Platelet Protection

Designed for the Secondary Prevention of Heart Attacks and Strokes in High Risk Cardiovascular Patients

Jan 07, 2016, 12:53 ET from New Haven Pharmaceuticals, Inc.

NEW HAVEN, Conn., Jan. 7, 2016 /PRNewswire/ -- New Haven Pharmaceuticals, Inc. today announced the availability by prescription of DURLAZA, the first and only 24-hour, extended-release aspirin capsules (162.5mg) approved by the U.S. Food and Drug Administration (FDA) for the secondary prevention of stroke and acute cardiac events, including myocardial infarction (heart attack) in high-risk cardiovascular patients.  DURLAZA is now commercially available for physicians and their patients.

"We are very pleased to announce the national availability of DURLAZA as a new, novel alternative option for high-risk cardiovascular patients who would benefit from increased all-day protection from clotting risks," said Patrick Fourteau, CEO of New Haven Pharmaceuticals. "We are confident of the positive effects that DURLAZA has on stabilizing and maintaining platelet inhibition for a full 24-hours – no other single, low-dose aspirin can offer this level of coverage to these patients. We believe that DURLAZA offers a significant benefit by reducing the risk of secondary strokes and heart attacks."

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.

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 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

Please click here for full Prescribing Information for DURLAZA.

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.



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