Fifth product approved by the US FDA licensing Elan’s NanoCrystal®
technology for various formulations
Elan Drug Technologies, a business unit of Elan Corporation, plc (NYSE:
ELN) announces the first approval of a long-acting injectable
formulation using Elan Drug Technologies’ proprietary NanoCrystal®
technology.
Late last week, Janssen, a division of Ortho-McNeil-Janssen
Pharmaceuticals, announced the approval of INVEGA® SUSTENNA™,
the first once monthly atypical antipsychotic injection, by the United
States Food and Drug Administration.
“The approval of INVEGA® SUSTENNA™, is an important milestone
for our NanoCrystal® technology as it marks the first
long-acting injectable product approved by regulatory authorities using
the technology,” announced Shane Cooke, Executive Vice President and
Head of Elan Drug Technologies. “Our versatile NanoCrystal®
technology in this instance, allowed for a stable, low viscosity, high
drug-loaded formulation in a small injection volume, to be developed.”
The NanoCrystal® technology, a technology enabling the
formulation of poorly water soluble compounds for all routes of
administration, allows for a ready-to-use one month duration
intramuscular depot formulation of paliperidone palmitate which can be
administered by healthcare professionals. The intramuscular injection is
administered using a small bore needle and small volume syringe,
negating the need for a power injector. By applying the NanoCrystal®
technology to paliperidone palmitate, for the first time, healthcare
professionals will be able to provide patients with consistent
medication coverage for one month potentially allowing them to improve
compliance for schizophrenic patients.
NanoCrystal® technology, is a proprietary technology
developed by Elan Drug Technologies through Elan Pharma International
Limited and other Elan affiliates. INVEGA® SUSTENNA™ is the
fifth licensed product approved by the US FDA using Elan’s NanoCrystal®
technology for various formulations.
About Elan Drug Technologies and NanoCrystal®
technology
Elan Drug Technologies, one of the world’s leading drug delivery
businesses, is a business unit of Elan Corporation, plc. As a fully
integrated drug delivery business, Elan Drug Technologies delivers
clinically meaningful benefits to patients, by using its extensive
experience and proprietary delivery technologies in collaboration with
pharmaceutical companies.
