Intec Pharma Ltd. (TASE: INTP) reported today that the US Food and Drug Administration (FDA) has approved the launch of a Phase II clinical trial to study its accordion pill for sleep disorders.
The report comes only a few weeks after Intec reported positive interim results in a Phase IIb clinical trial of its accordion Levodopa pill for Parkinson's disease.
Intec estimates that if the clinical trial proves successful in the next few months, the company will consider options to market the drug to leading global pharmaceutical firms. A deal would grant an external license to complete the development, production, and marketing of the product.
Intec said that the current study includes tens of patients suffering from sleep disorders, who will receive the accordion pill containing the medication Zaleplon. The study will track how many times patients awaken, for how long, and sleep time during the night. The study will be conducted in leading sleep laboratories at medical centers in the US and Israel.
The firm expects that the accordion pill technology will improve the efficiency of Zaleplon, by keeping it in the stomach during most of the night, and steadily releasing the medication, improving sleep quality and preventing a hangover effect the next day.
The market for sleep disorder medications was estimated at $4.1 billion in 2007, in seven leading markets - the US, UK, Japan, France, Germany, Switzerland, and Italy.
Intec's accordion pill is a regular sized capsule. Folded up inside (like an accordion) is a material that contains one or more drugs. After the capsule dissolves, the material remains in the stomach for as long as twelve hours, releasing the drugs it contains. Later on, the material itself degrades.
Published by Globes [online], Israel business news - www.globes-online.com - on September 15, 2010
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