Espero Acquires DURLAZA® (aspirin) Extended Release Capsules for Secondary Prevention of Stroke and
Tuesday, February 7, 2017
Espero Acquires DURLAZA® (aspirin) Extended Release Capsules
for Secondary Prevention of Stroke and Acute Cardiac Events
JACKSONVILLE, Fla. (Feb. 7, 2017) – Espero Pharmaceuticals, Inc., a commercial-stage cardiovascular pharmaceutical company, today announced that the company has acquired the global rights to DURLAZA® (aspirin) Extended Release Capsules. Company officials will provide an update on Feb. 13, 2017 at the BIO CEO & Investor Conference held at the Waldorf Astoria New York.
DURLAZA is an FDA-approved and commercially available prescription 24-hour extended-release aspirin capsule, the first and only once-daily drug of its kind, indicated for the secondary treatment of stroke and acute cardiac events. Approved in September 2015, DURLAZA is designed to reduce the risk of death and myocardial infarction in patients with chronic coronary artery disease, and reduce the risk of death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attack (TIA). www.durlaza.com
“According to the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) Task Force on Practice Guidelines, low-dose aspirin is a recommended treatment for patients with stable ischemic heart disease (SIHD), unless contraindicated, with the goal to improve survival,” commented Quang Pham, Espero Chief Executive Officer.
“DURLAZA will compliment our portfolio of cardiovascular treatments, including GONITRO™ (nitroglycerin sublingual powder), and enable us to leverage our commercial infrastructure,” added Jeff Cole, Espero President and Chief Financial Officer.
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). The U.S. Preventive Services Task Force (USPSTF) pointed out that heart disease kills many Americans. The USPSTF, whose recommendations often are used as the basis for medical policy, says adults in their 50s who have a 10 percent or greater risk of heart disease over the next 10 years should take a low-dose aspirin daily to prevent heart disease.
“Cardiovascular disease, including heart attack and stroke, is responsible for 30 percent of all deaths in the United States,” as reported by the USPSTF. “About 40 percent of American adults over 50 currently take a daily aspirin to prevent heart attacks or strokes. More than 26 million adults have been diagnosed and are living with heart disease. Nearly 8 million adults have a history of heart attack and 6 million have a history of stroke.”
While the body is making platelets 24-hours a day, current immediate-release traditional aspirin only stays in the blood for a mean duration of approximately 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.
With GONITRO™ and DURLAZA, Espero now has two FDA-approved standard of care prescription medications for treating SIHD. DURLAZA was previously marketed by New Haven Pharmaceuticals, headquartered in Connecticut.
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.
- DURLAZA may cause gastric ulceration and bleeding. Avoid use of DURLAZA 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
- Renal: Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure
- Alcohol: Do not take DURLAZA 2 hours before or 1 hour after consuming alcohol.
- Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension and hyperkalemia.
- Anticoagulant and antiplatelets: Increased risk of bleeding.
- Anticonvulsants: Decreased phenytoin concentration and increased serum valproic acid levels.
- Methotrexate: Increased risk of bone marrow toxicity.
- NSAIDs: Increased risk of bleeding. Nonselective NSAIDs may interfere with the antiplatelet effect of DURLAZA.
Please click here for full Prescribing Information for DURLAZA.
About Espero Pharmaceuticals
Espero Pharmaceuticals, Inc., www.esperopharma.com, is a commercial-stage cardiovascular pharmaceutical company engaged in maximizing the commercial value of proven treatments that improve the quality of life for patients. Espero is focused on compounds with proven safety and efficacy administered via novel delivery solutions in the cardiovascular category. Through Jacksonville Pharmaceuticals, its wholly owned subsidiary, the company markets and distributes selected generic pharmaceutical products including the authorized generic version of Nitrolingual® Pumpspray (nitroglycerin lingual spray).