Eurand announced that the US Food and Drug Administration (FDA) has granted final marketing clearance to Reliant Pharmaceuticals LLC for InnoPran XL (propranolol hydrochloride) Extended Release capsules, a once-a-day chronotherapy, which utilizes Eurand's novel Diffucaps technology.
InnoPran XL is a beta-blocker and will be used in the treatment of hypertension. InnoPran XL provides 24-hour blood pressure control in a once daily formulation and a flexible dosing range from 80 mg to 120 mg. It is the only product in its class approved for administration in the evening and can be used alone or in combination with other anti-hypertensive agents. With evening administration, clinical trials have shown a reduction in blood pressure in the early morning hours and sustained control throughout the day. According to the American Heart Association, approximately 60 million Americans suffer from hypertension. These patients often experience an increase in blood pressure and heart rate in the early morning hours and, as a result, are more vulnerable to cardiac events during that time.
To address patients' early morning susceptibility to cardiovascular events, InnoPran XL was developed as a chronotherapy using Eurand's Diffucaps technology. As a result, patients can take the drug at bedtime and have optimal protection during the early morning hours when the risk of experiencing adverse cardiovascular events, including heart attack, is heightened. When taken at bedtime, InnoPran XL has a delayed release of approximately four hours, after which drug plasma levels rise progressively to provide peak plasma concentrations approximately 12-14 hours after dosing.
"The approval of InnoPran XL is the second regulatory approval in the US in the past two years for products developed using Eurand's Diffucaps technology. These approvals demonstrate the value of Eurand's technology platforms and are a testament to our success as a leader in drug delivery," said Gearoid Faherty, Chief Executive Officer of Eurand. "The development of InnoPran XL showcases the flexibility of our Diffucaps technology and confirms Eurand's ability to develop products with unique drug release profiles."
The New Drug Application (NDA) for InnoPran XL was filed in November 2001 and was accepted for review by the FDA in February 2002. Eurand has received product development payments for this program and will receive royalties on product sales as well as manufacturing revenue for supplying the product.
"InnoPran XL represents a pioneering concept in the treatment of high blood pressure," said Joseph Krivulka, President and Co-Founder of Reliant. "Working with our partner Eurand and their Diffucaps technology, we were able to formulate a drug release profile to mirror the body's natural circadian rhythm such that maximum anti-hypertensive protection effect is available during the period of greatest risk for adverse cardiovascular events."
Dr. Domenic Sica, Chairman of Clinical Pharmacology and Hypertension at Virginia Commonwealth University in Richmond, Virginia said, "InnoPran XL represents a breakthrough in the treatment of hypertension. Nighttime dosing results in clinically efficacious blood levels in the early morning hours -- the time when the majority of adverse cardiovascular events, such as heart attacks, occur. With the introduction of InnoPran XL, physicians now have an important new option in the management and treatment of hypertension."
Eurand's Diffucaps technology provides customized release profiles for optimal therapeutic results. This technology is a multi-particulate system in which individual beads of the drug are prepared with specific rate-controlling membranes providing a unique release profile. Customized release profiles can then be achieved by combining different types of beads in a capsule.