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FDA Approves Durlaza

FDA Approves Durlaza (aspirin) ER Capsules for Secondary Prevention of Stroke and Acute Cardiac Events

New Haven, CT, September 8th, 2015 – New Haven Pharmaceuticals, Inc. a privately held specialty pharmaceuticals company, today announced that the U.S. Food and Drug Administration (FDA) has approved Durlaza (aspirin), the first and only 24-hour, Extended Release Capsules, (162.5mg) for the secondary prevention of stroke and acute cardiac events, including myocardial infarction (heart attack).

“Durlaza is an aspirin formulation for secondary prevention in high-risk CVD patients. The aspirin delivery technology in Durlaza extends the release of aspirin in a manner designed to provide a stable antiplatelet effect over the course of the day. The latter unique property of Durlaza is important as patients at risk generate new platelets throughout the day. Also, as one dosage form of any medication rarely works for all patients, Durlaza provides an alternative dosing option for patients who need aspirin for cardiovascular risk prevention” said Paul Gurbel, MD, Associate Chief for Research and Director of the Sinai Center for Thrombosis Research, Sinai Hospital, Baltimore, Professor of Medicine, Johns Hopkins University, Adjunct Professor of Medicine, Duke University.

"We are very pleased to have received FDA approval for Durlaza for secondary prevention for cardiovascular patients, and we now look forward to making it available by prescription in the fourth quarter of 2015,” said Patrick Fourteau, CEO of New Haven Pharmaceuticals. “We believe Durlaza represents an important advancement by extending aspirin anti-platelet protection for high risk patients in the United States.”

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).

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. Durlaza, like immediate-release aspirin, increases the risk of bleeding and gastric ulceration, and may cause fetal harm when administered to a pregnant woman.

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 two hours before or one 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

Posted: September 2015

Durlaza (aspirin) FDA Approval History

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