Intec Pharma - Zaleplon GR for Insomnia

Zaleplon GR for Insomnia

Current epidemiological data suggest that insomnia is one of the most common CNS disorders, affecting one-third of the general population.

In 2005, the Sleep in America poll found that 54% of adults reported one or more symptoms of insomnia at least a few nights a week, with one-third experiencing at least one symptom of insomnia every night or almost every night¹

There are three key attributes expected from an optimal insomnia drug:

1. Rapid sleep onset
2. Sleep maintenance
3. No residual effects (hangover-like symptoms the following day)

There are no current medications that both induce and successfully maintain sleep without having next day residual effects. Conceptually, an ideal treatment would be a modified-release formulation of a drug that is rapidly absorbed (therefore provides a rapid sleep induction) and has a very short half-life (associated with no residual effects). Continuous release of the drug overnight would provide efficient sleep maintenance.

Intec's product

Intec Pharma is developing a gastro retentive formulation of Zaleplon.

Zaleplon is the fastest and shortest acting drug of its class. It is absorbed rapidly, reaching peak blood levels within an hour after dosing and is rapidly cleared from the blood with a terminal half-life of 1 hour. Accordingly, it is associated with rapid sleep induction and has minimum next-day residual effects.

The Accordion Pill enables a continuous duodenal infusion of Zaleplon throughout the night, thereby prolonging the absorption phase and keeping a sufficient blood concentration for sleep maintenance over night.

Phase I

The Accordion Pill Zaleplon has demonstrated statistically significant superiority over the marketed Zaleplon (Sonata)

¹ Datamonitor, Pipeline Insight: Insomnia, April 2007

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