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FDA approves new formulation based on bioequivalency with existing product
In a co-development project, GSK’s Lamictal (lamotrigine) has been reformulated as an orally disintegrating tablet using the Advatab and Microcaps technologies of Eurand NV (Milan; US HQ: Vandalia, OH). Lamictal is currently a $1.3-billion product in the US, and is prescribed primarily for the longterm treatment of bipolar disorder and a variety of seizure disorders. The ODT version, together with Eurand’s taste-masking encapsulation technology, called Microcaps, is expected to make the drug more available to patients with difficulty swallowing.
“Patients with epilepsy or bipolar disorder can have difficulty swallowing tablets. Unfortunately, this problem may go unrecognized, because many patients don’t discuss this issue with their healthcare providers,” said Daniel Lieberman, MD, associate professor and clinical director of the George Washington University Dept. of Psychiatry and Behavioral Sciences, in a statement released by GSK. “Orally disintegrating tablets, like Lamictal ODT, offer an option for patients who have difficulty swallowing tablets.”
Under terms of the agreement, Eurand will manufacture Lamictal ODT exclusively, and may have certain rights to commercialize it outside the US. Eurand will receive an undisclosed milestone payment upon launch, revenue for manufacturing Lamictal ODT tablets for GSK, royalties on net sales of the product and milestone payments in connection with Lamictal ODT achieving predetermined sales levels in the U.S. marketplace.
Eurand’s proprietary Advatab technology employs granulation and tabletting technology to produce the ODT form, which can be taken by the patient with our without water. The Microcaps encapsulation technology coats drug particles to mask the drug’s taste while allowing it to dissolves in the stomach.
“We were delighted to have the opportunity to use our AdvaTab(R) and Microcaps(R) proprietary technologies to co-develop Lamictal ODT with GSK, and we look forward to a successful launch,” said Gearoid Faherty, Chairman and CEO. “We see Lamictal ODT, Eurand’s fifth FDA-approved drug since 2001, as another clear demonstration of the breadth of our drug formulation expertise and the depth of our pipeline.” PC