In January, New Haven Pharmaceuticals, Inc. (NHP) announced the FDA clearance of DURLAZA, the first and only 24-hour, extended-release aspirin capsules (162.5 mg) for the secondary prevention of stroke and acute cardiac events, including myocardial infarction (heart attack) in high-risk cardiovascular patients.
An open-label, single-center study concluded that the new, extended-release orally-administered aspirin formulation provided sustained antiplatelet effects over 24 hours in patients with a favorable safety profile. In this study, patients with type 2 diabetes with a history of cardiovascular disease (or multiple CV risk factors) were treated daily with DURLAZA for 14 days +/- four days. Maximizing the benefit of aspirin by providing consistent platelet inhibition, DURLAZA utilizes extended-release, microcapsule technology to prolong aspirin release. Patrick Fourteau, CEO of NHP, participated in a Q&A about the company’s new product.
What factors contributed to the design of DURLAZA?
Fourteau: The intent of the formulation of DURLAZA was two-fold:
First, DURLAZA was designed to deliver aspirin, the most well-known product in cardiovascular risk prevention, in a “low and slow” fashion so as to avoid overly high concentrations beyond the portal circulation, the point at which aspirin acetylates, and thus inhibits platelets. Scientific rationale led to the concept that excess peripheral aspirin concentration could potentially contribute to inhibition of peripheral endothelium-derived PGI2 (Prostacyclin), which can be an unintended, negative consequence of aspirin therapy.
Second, conventional aspirin was developed to perform as a rapid-onset pain reliever, not as an around-the-clock platelet inhibitor. DURLAZA, conversely, was specifically designed to release aspirin into the circulation over every hour of the 24-hour dosing interval, as platelets are produced at a rate of four billion platelets per hour, every hour of the day.
What, would you say, is one of the greatest feats about DURLAZA?
Fourteau: Numerous studies have shown that patients with type 2 diabetes mellitus and cardiovascular disease (CVD) are at much higher risk of cardiovascular events compared to patients without type 2 diabetes. It has been determined that patients with type 2 diabetes and CVD have a substantial risk for high platelet turnover (HPT) and high on-treatment platelet reactivity (HPR) while taking conventional aspirin. This incomplete response to aspirin is thought to be at least in part to the vascular disease and subsequent HPT/HPR that ensues. Simply put, patients with type 2 diabetes and CVD produce an increased number as well as larger and more reactive platelets.
DURLAZA was studied in patients with type 2 diabetes and CVD (or multiple CVD risk factors) and demonstrated greater than 95 percent platelet inhibition over the entire 24-hour dosing interval. Achieving substantial and sustained platelet inhibition in the most challenging patients, those with type 2 diabetes and CVD, was a milestone for DURLAZA—achieving the result of the intended design.
Could you describe how DURLAZA delivers controlled-release aspirin over 24-hours?
Fourteau: DURLAZA utilizes a well-known extended release technology, the same utilized in a product with hundreds of thousands of prescriptions, Coreg-CR. The MircoPump technology utilized in DURLAZA relies on microcapsular design, which is a complex design deploying polymer coatings of differing rates of solubility, and thus varying the release rate of the proprietary crystalline aspirin core. This combination results in the proven 24-hour release profile of DURLAZA.
Do you see developing trends in new aspirin medications or in stroke and acute cardiac events treatment?
Fourteau: Absolutely. NHP believes aspirin is the best known risk prevention product, yet is also the one with the most potential of any product in the pharmaceutical arena. For example, in addition to cardiovascular and cerebrovascular prevention, aspirin is being explored for cancer prevention, including colorectal, pancreatic, and other cancers. Further, aspirin is being evaluated in numerous other diseases, including Alzheimer’s disease.
The extended release technology along with the value of aspirin, as illustrated in the product DURLAZA, may prove to be beneficial in numerous applications. NHP is a nimble organization, founded on rich pharmaceutical industry experience and capable of partnering with expert clinicians to define and maximize all potential opportunities for our portfolio. Needlessly said, NHP will optimize the opportunity that clearly exists with DURLAZA.