New Haven Pharmaceuticals Presents Survey Results that Showed High Risk Cardiovascular Patients Believed That There are Generally Greater Benefits Associated with Prescription Versus OTC Medications

Results Presented at the American Pharmacist Association Annual Meeting

Positive Data Presented on DURLAZA ™ as Being Well Tolerated, with a Favorable Safety Profile Comparable to Immediate Release Low Dose Aspirin

07 Mar, 2016, 13:24 ET from New Haven Pharmaceuticals, Inc.

NEW HAVEN, Conn., March 7, 2016 /PRNewswire/ -- New Haven Pharmaceuticals, Inc. today announced the results of a Company sponsored survey that showed patients with a history of one or more cardiovascular events and were taking a daily dose of aspirin, had generally more favorable attitudes toward the use of prescription compared with OTC medications. This is the first and only survey, conducted in a Harris Poll of 1,000 people, to assess attitudes and beliefs regarding the use of prescription and OTC medications in patients taking aspirin for the prevention of secondary cardiac events. The survey results also showed that most respondents believed that aspirin was a beneficial part of their cardiovascular prevention regimen, and they were not averse to participating in active prescription management regimes for aspirin, which could enhance overall patient adherence to treatment.

The Company also presented positive study data that shows that DURLAZA, the first prescription low dose, extended release aspirin, is well tolerated and has a favorable safety profile comparable to low dose, immediate release aspirin. These data were highlighted during poster presentations at the American Pharmacist Association (APhA) annual meeting in Baltimore, MD.

The studies, titled, "Perceptions of Prescription and Over-the-Counter Medication Use in Populations with a History of Cardiovascular Disease," by Patrick J, Dillaha L, Pennell A, New Haven Pharmaceuticals Inc. and "A New Extended-Release Acetylsalicylic Acid Formulation is Well Tolerated: Analysis of Three Double-Blind Studies," by Patrick J, Johnson A, Dillaha L, Pennell A, New Haven Pharmaceuticals Inc. were presented by Andy Pennell, PharmD, Vice President, Medical Affairs at New Haven Pharmaceuticals.

Patrick Fourteau, CEO of New Haven Pharmaceuticals, said, "These survey results show that patients who already experienced at least one cardiovascular event had a favorable attitude toward actively managing their treatments with prescription compared to OTC medications.  DURLAZA, which is available by prescription, provides a significant benefit to patients by providing 24–hour protection against platelet aggregation (blood clotting), which may help prevent a second heart attack or stroke. Additionally, the survey showed that 17% of participants in the survey admitted that they forgot to take a dose of aspirin at least once a week. We believe DURLAZA, as a prescription medication, provides a means to assess and potentially increase patient adherence to treatment."

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) in high-risk cardiovascular and diabetes patients.

DURLAZA received FDA approval in September 2015. In an open-label, single-center study, high-risk patients with Type II Diabetes (T2DM) and 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 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

Indications and Usage

DURLAZA (aspirin) Extended Release Capsules (162.5 mg) are 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 chronic stable angina, or;
  • 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 of bleeding.
  • Aspirin may cause gastric ulceration and bleeding. Avoid use of aspirin in patients with active peptic ulcer disease.
  • DURLAZA, when administered to a pregnant woman, can cause fetal harm, 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.
  • Co-administration of DURLAZA with renin-angiotensin system (RAS) inhibitors is not recommended in patients who are elderly, volume-depleted, or have compromised renal function, as co-administration may lead to deterioration of renal function. Monitor renal function periodically in patients receiving RAS inhibitors and aspirin. NSAIDs may attenuate the anti-hypertensive effects of RAS inhibitors.
  • Co-administration 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, a specialty pharmaceuticals company utilizing proprietary technology developed by Yale University, is dedicated to developing and commercializing innovative drugs to improve the health and quality of patients suffering from serious medical conditions, including cardiovascular disease, the world's leading cause of death. DURLAZA, approved by the FDA and now available, is the first and only prescription, low dose, extended release aspirin (162.5mg) for the secondary prevention of stroke and acute cardiac events, including myocardial infarction (heart attack) in high-risk cardiovascular and diabetes patients.  The Company is also developing additional products incorporating zinc salts, including a proprietary product designed to lower stomach acid in patients suffering from gastro-esophageal reflux disease (or GERD) and a combination product with DURLAZA. For additional information about the Company and DURLAZA, please visit www.newhavenpharma.com.

Contacts:

Dr. Larry Dillaha
New Haven Pharmaceuticals
Executive Vice President, Operations
203-488-4620

Joseph T. Schepers
SCIR Consulting
770-558-5517
joeschepers1@gmail.com

SOURCE New Haven Pharmaceuticals, Inc.



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