New Haven Pharmaceuticals was founded with a strong lineage of achievement and we build on our internal strengths through relationships with experts and innovators around the world. Our collaborative approach will drive our pipeline by seeking to identify where we can leverage expertise and innovative thinking to bring better outcomes to patients through delivery of medications.
It’s our belief that — for nearly every disease — one size does not fit all; one dose does not fit all; and one dosing formulation does not fit all.
We are very pleased to have received approval from the FDA on September 4, 2015, for DURLAZA for secondary prevention for cardiovascular patients. New Haven Pharmaceuticals developed DURLAZATM to assist the more than 25 million people in the US being treated for the secondary prevention of stroke and acute cardiovascular events — to reduce the risk of stroke or acute cardiac events in patients who have suffered a prior stroke or acute cardiac event.
The Company designed DURLAZA to be slowly released into the bloodstream over 24 hours. Currently available aspirin products are released over a shorter period of time. The Company believes that DURLAZA will provide the benefit of extended aspirin release to many among the growing number of patients who currently take aspirin daily to reduce the secondary risk of clotting, heart attack and stroke.
New Haven Pharmaceuticals is also developing gastrointestinal and other products through our proprietary zinc salts program with our innovative research collaborator, Dr. John Geibel, Vice Chair of Surgery at Yale School of Medicine.
One of these novel products under development is a controlled-release formulation of zinc salts designed to lower stomach acid production and will be evaluated in patients suffering from excessive acid production as well as breakthrough GERD (Gastro Esophageal Reflux Disease).
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
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