DURLAZA™ is a proprietary, once-daily oral 24-hour controlled-release aspirin product. DURLAZA™ is a novel oral dosage form that exhibits an extended release profile specifically designed to continuously deliver aspirin in the circulation over a 24 hr time period. This unique characteristic makes DURLAZA™ particularly suited to the secondary prevention of stroke and cardiovascular events, indications for which aspirin is currently used. The design of the Micropump® microparticles allows for a prolonged transit time to release in the circulation, with a plasma mean residence time extended up to 24 hours. Over-the-counter ("OTC") aspirin is currently only available in immediate and delayed release (enteric coated) formulations, which release aspirin into the circulation over a shorter period of time. Therefore, DURLAZA™ is intended to extend therapeutic coverage as compared to the OTC aspirin products currently available.
- Anti-platelet Aspirin Therapy - Secondary Prevention of Stroke + Acute Cardiac Events
DURLAZA™, the Company's most advanced product candidate, is being developed for the secondary prevention of stroke and acute cardiovascular events. A US NDA is expected to be submitted to FDA in Q3 2014, with US approval and a US commercial launch in Q3 2015.
Market Opportunity - Over 100 million people globally currently take aspirin daily to prevent heart attack and stroke. Aspirin prevents clot formation through the inhibition of thromboxane, a naturally-occurring prostaglandin derivative in the body that induces platelet aggregation.
DURLAZA™ Advantages - DURLAZA™ represents a unique product opportunity that was developed in consultation with a Nobel laureate to improve treatment over conventional aspirin products, via its specially designed 24 hour controlled-release profile.
US NDA Submission - Based on 2 pre-NDA meetings with the FDA, NHP plans to submit an NDA for NHP-554C in Q3 2014 for the secondary prevention of stroke and acute cardiovascular events (consistent with the current FDA monograph: professional labeling for aspirin products). Approval is expected in Q3 2015.
NHP-554CZ - Antiplatelet Aspirin Therapy
NHP-554CZ, a combination form of NHP-554C (utilizing Yale IP involving zinc salts), potentially represents an improved second generation Micropump® Aspirin product. Development is expected to begin in 2014.